Actis Total Hip System 2 Year Follow-up
Phase: NA
Conditions: Osteoarthritis, Traumatic Arthritis, Rheumatoid Arthritis, Congenital Hip Dysplasia, Avascular Necrosis of the Femoral Head, Acute Traumatic Fracture of the Femoral Head or Neck, Certain Cases of Ankylosis, Non-union of Femoral Neck Fractures, Certain High Sub-Capital & Femoral Neck Fractures in Elderly
Sponsor: DePuy Orthopaedics

CONFIDENTIAL 
   Page 1 of 53 
  DePuy Synthes / Actis® Total Hip System 
Version Date: May 7, 2018
 Protocol #14014 / Version B 
DePuy Synthes 
CLINICAL RESEARCH 
CLINICAL INVESTIGATION PLAN (CIP) 
Actis® Total Hip System 2-Year Follow-up 
Clinical Investigation Plan (CIP) 
Number: 
14014 
Country: 
U.S. 
CIP Prepared By: 
 
DePuy Synthes  
CIP Version: 
Version Date:  May 7, 2018 
Version B 
Clinical Investigation Sponsor: 
DePuy Synthes  
700 Orthopaedics Drive 
P.O. Box 988 
Warsaw, IN 46581 
Telephone: (800) 829-7003 
Fax: (574) 371-4950 
Medical Monitor 
 
Medical Device Business Services, Inc. 
(hereafter referred to as DePuy Synthes) 
Office: 
 
Mobile: 
 
NCT02783274
PPD
PPD
PPD
PPD

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Version Date: May 7, 2018                                   Protocol #14014 / Version B 
 
 
 
  
1 
PROTOCOL SIGNATURE PAGE (PRINCIPAL INVESTIGATOR) 
Actis® Total Hip System 2-Year Follow-up 14014 
 
I have read this protocol and agree to conduct this clinical investigation plan in accordance with 
the design and specific provisions outlined herein. 
 
I understand I am solely responsible to ensure the investigation is conducted in accordance with 
Good Clinical Practices, Declaration of Helsinki, applicable FDA regulations and ISO 14155 
standards, local regulations, and the signed agreement with DePuy Synthes and with the protocol 
outlined herein.  
 
I will provide copies of the protocol and all pertinent information to all individuals responsible to 
me who will assist in the conduct of this study. I will discuss this material with them to ensure they 
are fully informed regarding the device and the conduct of the study.  
 
I will fulfill the requirements of my Institutional Review Board (IRB/REB/EC), or other oversight 
committee, to ensure complete and continual oversight of this clinical investigation.  
 
I will use an Informed Patient Consent Document approved by DePuy Synthes and my reviewing 
oversight committee.  
 
I agree to report all information or data in accordance with the protocol and I agree to report any 
serious adverse events as defined in this protocol to DePuy Synthes and my reviewing oversight 
committee. 
 
I agree to permit DePuy Synthes, the IRB/REB/EC or other applicable regulatory authorities, direct 
access to all records, including source data/documents, relating to the clinical investigation, 
whether paper-based or electronic data capture (EDC). 
 
The below signature confirms I have read and understood this clinical investigational protocol and 
its associated amendments or attachments, and will accept respective revisions or amendments 
provided by DePuy Synthes.  
  
PRINTED OR TYPED NAME 
 SIGNATURE  DATE 
 
  
  
Principal Investigator 
  
  

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Version Date: May 7, 2018                                   Protocol #14014 / Version B 
 
 
 
2 
CONTENTS 
1 Protocol Signature Page (Principal Investigator) .............................................. 2 
3 Table 1 List of Appendices ................................................................................... 5 
4 Table 2 Study Summary ....................................................................................... 5 
5 Table 3 Definition of Terms ................................................................................. 9 
6 Subject Management Study Schedule ............................................................... 13 
7 Introduction ......................................................................................................... 14 
8 Rationale .............................................................................................................. 14 
8.1 Duration of Study ......................................................................................... 15 
9 Subject Definition ................................................................................................ 15 
9.1 Subject Population ....................................................................................... 15 
9.2 Subject Screening ......................................................................................... 15 
9.3 Subject Eligibility (Inclusion and Exclusion Criteria) ................................. 15 
9.4 Inclusion Criteria: ........................................................................................ 16 
9.5 Exclusion Criteria: ....................................................................................... 17 
9.6 Enrollment & Subject Identification (ID) Number ...................................... 18 
10 Objective and Endpoints .................................................................................... 19 
10.1 Primary Objective ........................................................................................ 19 
10.2 Primary Endpoint ......................................................................................... 19 
10.3 Secondary Endpoints ................................................................................... 19 
10.4 Tertiary Endpoints ....................................................................................... 19 
10.5 Study Design ................................................................................................ 19 
10.6 Optional (Electronic) Patient Activity Tracking Device.............................. 20 
10.7 Study Database ............................................................................................. 20 
10.8 Treatment Assignment ................................................................................. 21 
11 Radiographs ......................................................................................................... 21 
12 Subject Evaluations ............................................................................................ 21 
12.1 Summary of Subject Evaluations ................................................................. 21 
12.2 Table 4 Summary of Subject Evaluation and eCRFs ................................... 22 
12.3 Actions for Screen Failure Subjects ............................................................. 25 
12.4 Table 5 Actions for Screen Failure Subjects ................................................ 25 
12.5 Actions for Postoperative Withdrawals ....................................................... 26 
12.6 Table 6 Actions for Postoperative Withdrawal ............................................ 26 
13 Adverse Events (AEs) ......................................................................................... 27 
13.1 Table 7 Definitions of Adverse Event (AE) Types, Device Deficiency. ..... 32 
13.2 Definition of AE Severity ............................................................................ 34 
14 Determination of Relationship to Device and/or Procedure and ADEs and 
SADEs .................................................................................................................. 35 
14.1 Device or Procedure Related ....................................................................... 35 
14.2 Worsening Adverse Events .......................................................................... 35 
14.3 Pre-existing Medical Conditions .................................................................. 35 

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14.4 Minimization of Risks .................................................................................. 36 
14.5 Table 9 Revisions and Reoperations ............................................................ 36 
15 Informed Patient Consent (IPC) Process .......................................................... 37 
16 Statistical Methodology ...................................................................................... 39 
16.1 Study Design ................................................................................................ 39 
16.2 Treatment Assignment ................................................................................. 39 
16.3 Levels of Significance .................................................................................. 39 
16.4 Interval Windows ......................................................................................... 40 
16.5 Handling of Missing Data ............................................................................ 40 
16.6 Primary and Secondary Endpoints ............................................................... 40 
16.7 Hypotheses ................................................................................................... 40 
16.8 Analysis Sets ................................................................................................ 40 
16.9 Sample Size Justification ............................................................................. 41 
16.10 
Analysis Plan ................................................................................ 41 
16.11 
Primary Endpoint .......................................................................... 42 
16.12 
Secondary Endpoints .................................................................... 42 
16.13 
Tertiary Endpoints ........................................................................ 44 
16.14 
Interim Analysis ............................................................................ 44 
17 Data management ............................................................................................... 44 
17.1 Data Management for Subject Operative Details and Follow-up Evaluations
 
44 
18 Clinical Monitoring ............................................................................................. 45 
19 Study Devices ....................................................................................................... 45 
20 Deviations & Non-compliance Handling .......................................................... 46 
20.1 Lost to Follow-up ......................................................................................... 46 
21 Ethical Principles ................................................................................................ 47 
22 Principal Investigator Responsibilities ............................................................. 47 
22.1 Institutional Review Board Approval (IRB or REB or EC) ........................ 47 
22.2 Informed Patient Consent (IPC) ................................................................... 47 
22.3 Source Documentation ................................................................................. 48 
22.4 Electronic Case Report Form (eCRF) Completion ...................................... 48 
22.5 Clinical Investigation Plan (CIP) Adherence ............................................... 49 
22.6 Clinical Investigation Plan (CIP) Amendments ........................................... 49 
22.7 Investigator Reporting Responsibilities ....................................................... 49 
22.8 Table 10 Principal Investigator Reporting Responsibilities ........................ 49 
Table 10 Principal Investigator Reporting Responsibilities ................................ 49 
22.9 Investigator Site Files (ISF or Regulatory Binder) ...................................... 50 
23 Sponsor Obligations ............................................................................................ 50 
23.1 Ethics (IRB/REB/EC) Approval .................................................................. 50 
23.2 Investigator Training .................................................................................... 51 
23.3 Sponsor Reporting Responsibilities ............................................................. 51 
23.4 Insurance ...................................................................................................... 52 
23.5 Financial Agreement .................................................................................... 52 
23.6 Sponsor Study Termination ......................................................................... 52 
24 Publication Plan .................................................................................................. 52 

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25 Study Summary Statement ................................................................................ 53 
 
 
3 
  TABLE 1 LIST OF APPENDICES  
Table 1 List of Appendices 
Appendix 
Details 
A 
Electronic Case Report Forms (eCRFs) 
B 
Informed Patient Consent Template  
C 
Surgical Technique  
D 
Radiographic Protocol 
E 
Device Product Codes for Actis® Total Hip System  
F 
References  
G 
Patient Activity Tracking Device and ActiTrack™ Application (app)  
4 
TABLE 2 STUDY SUMMARY 
Table 2 Study Summary 
Title: 
Actis® Total Hip System 2-Year Follow-up 
Treatment Device: 
Actis® Total Hip System (Featuring DUOFIX® Technology) 
Control Device: 
None: this is a non-comparative study 

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Table 2 Study Summary 
Title: 
Actis® Total Hip System 2-Year Follow-up 
Intended Use for 
Actis® Total Hip 
System: 
 
Cementless Total Hip replacement is indicated in the following conditions: 
A severely painful and/or disabled joint from osteoarthritis, traumatic 
arthritis, rheumatoid arthritis, or congenital hip dysplasia. Avascular 
necrosis of the femoral head. Acute traumatic fracture of the femoral head 
or neck.  
 
Cementless Hemi-hip arthroplasty, or replacement, is indicated in the 
following conditions: Acute fracture of the femoral head or neck that cannot 
be appropriately reduced and treated with internal fixation. Fracture 
dislocation of the hip that cannot be appropriately reduced and treated with 
internal fixation. Avascular necrosis of the femoral head. Non-union of 
femoral neck fractures. Certain high sub-capital and femoral neck fractures 
in the elderly. Degenerative arthritis involving only the femoral head in 
which the acetabulum does not require replacement. Pathology involving 
only the femoral head/neck and/or proximal femur that can be adequately 
treated by hemi-hip arthroplasty.  
 
The Actis® Total Hip System has been optimized for use with the anterior 
approach (AA with broach only technique). 
Primary Objective: 
Two-year (2-year) information regarding the performance of the 
commercially available Actis® Total Hip System in order to obtain and 
evaluate the clinical outcomes on a series of cementless primary total hip 
arthroplasty (THA) and hemi-hip arthroplasty procedures using clinical, 
radiographic and device and procedure related adverse event assessments.  
Study Design: 
 A prospective, uncontrolled, non-randomized, multicenter study.  
A total of 255 Subjects to include a minimum of 225 Primary THA 
Subjects and a cohort with a minimum of 30 hemi-hip arthroplasty 
Subjects will be prospectively enrolled into the study.  All Subjects will 
be seen for a preoperative clinic visit at the time of consent, and evaluated 
at the time of surgery, 6 weeks, 3 months, minimum 1 year, and minimum 
2-years postoperatively. 

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Table 2 Study Summary 
Title: 
Actis® Total Hip System 2-Year Follow-up 
Number of Sites: 
A minimum of 10 study sites will participate. Any one site may not enroll 
more than 40 Subjects (inclusive combination of both THA and hemi-hip 
arthroplasty Subjects) after reallocation from low enrollment sites, which 
will ensure that in a worst-case scenario, a minimum of 4 sites must 
contribute enrollment to the final sample size to represent variability across 
surgeons.  
Subject Population: 
Subjects at participating sites who meet the inclusion/exclusion criteria 
for this study.  
Sample Size: 
Sites will prospectively enroll a total of 255 Subjects to include a minimum 
of 225 Primary THA Subjects, and a cohort of a minimum of 30 hemi-hip 
arthroplasty Subjects.  
Study Duration: 
The anticipated duration of this investigation is approximately 3- to 4-years 
from the time of study initiation given that: 
x It may take up to 1-year from the time of study initiation to enroll total 
hip arthroplasty Subjects.  It is expected that the hemi-hip arthroplasty 
cohort may take longer than 1-year to enroll. 
x Each Subject will be followed until they have completed their 
minimum 2-year follow-up. 
x The study will be closed when all Subjects have completed minimum 
2-year follow-up.  

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Table 2 Study Summary 
Title: 
Actis® Total Hip System 2-Year Follow-up 
Primary, Secondary 
and Tertiary 
Endpoints: 
Primary endpoint:  
Harris Hip Score at minimum 2-years postoperatively.  
Secondary endpoints: 
x Harris Hip score at 3-months and 1-year 
x Radiographic evaluation at 2-years postoperatively, inclusive of leg 
length discrepancy 
x Type and frequency of device and procedure related AEs through 2-
years postoperatively  
x Device survivorship at 2-years postoperatively 
Tertiary endpoints:  
x Change in Subject Outcomes (i.e., FJS-12, HOOS and Subject Hip 
Evaluation) will be measured and compared from preoperative to 6-
weeks, 3-months, minimum 1-year and minimum 2-years. 
x Study Sites will be given the opportunity to participate in a non-required 
parallel activity (to collect tertiary outcomes) of this study, specifically, 
“Patient Activity Tracking”.  
x At the participating study sites, Subjects choosing to participate in 
Patient Activity Tracking will wear a device that looks somewhat like 
a wrist watch. The Patient Activity Tracking device will link via a 
downloaded mobile application (app) (i.e., ActiTrak™) to the Subject’s 
smartphone (i.e., iPhone or Android phone) or to a Sponsor provided 
Android tablet. Any Sponsor provided Android tablet will be for study 
use only in order to provide pre-populated passive and actively reported 
Subject activities such as Pain, Location of Pain, Mood/Emotion, 
Activities of Daily Living, and Range of Motion from the time of 
consent preoperatively through 3 months postoperatively. After 
surgery, there will be question about Subject Satisfaction periodically. 
Any Sponsor provided Android tablet will be returned to the Sponsor at 
the 3-month follow-up interval or at any premature study termination 
after consent and enrollment.  

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Table 2 Study Summary 
Title: 
Actis® Total Hip System 2-Year Follow-up 
Procedure Schedule: 
Subjects will be seen at the following intervals: preoperative, operative, 6- 
weeks, 3-months, minimum 1-year, and minimum 2-years 
postoperatively. 
Safety: 
Only device or procedure related adverse events (AEs) for enrolled 
Subjects are to be reported.  
5 
TABLE 3 DEFINITION OF TERMS  
Table 3 Definition of Terms 
Term 
Definition 
ActiTrak™ 
Application (app)  
A mobile application (app) is a computer program designed to run a mobile 
device, such as a smartphone (e.g., iPhone or Android phone) or tablet. For 
the purposes of this study the ActiTrak™ app will link the mobile Patient 
Activity Tracking device (the watch-like device that some Subjects may 
choose to wear in the study) to the study database.  
Android Tablet 
An Android tablet is a tablet-sized (small) personal computer (PC) that runs 
on Google's Android operating system (OS). Android tablets include almost 
all the key features found in a regular PC, including office applications, 
games, Web browsers and many other programs. For the purposes of this 
study, an Android tablet will be used to download the ActiTrak™ application 
to capture passive and active patient activities.   
(Reference: http://www.techopedia.com/definition/25194/android-tablets).  
Activity of Daily 
Living (ADLs)  
Activities of Daily Living: a term used in healthcare to refer to daily self-care 
activities within an individual's place of residence, in outdoor environments, 
or both. 
Clinical 
Investigation Plan 
(CIP) 
The CIP is a written document describing how the clinical investigation will 
be conducted. It includes the rationale, objectives, design and proposed 
analyses, methodology, monitoring, conduct and record-keeping of the 
clinical investigation. Clinical investigation is interchangeable with the term 
‘study’.  
Code of Federal 
Regulations (CFR) 
The CFR is the set of US FDA regulations that governs activities regulated 
by the FDA.  
Date of Surgery 
(DOS) 
Acronym for the actual date that surgery occurs – DOS.  
 

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Electronic Case 
Report Form 
(eCRF) 
A computerized system designed for the collection of data in electronic form. 
Ethics Committee 
(EC) 
Alternate term for Institutional Review Board (IRB) or Research Ethics 
Board (REB) - see below. 
Electronic Data 
Capture (EDC) 
A system designed for the collection of clinical data in electronic format.  
 
The EDC system that will be used in this clinical investigation has been 
validated in accordance with 21 CFR Part 11, European Commission’s 
Directive on Data Protection and US Safe Harbor Certification.  
Food and Drug 
Administration  
(FDA) 
The US FDA is an agency within the Department of Health and Human 
Services. The FDA is responsible for protecting the public health by assuring 
the safety, efficacy, and security of human and veterinary drugs, biological 
products, medical devices, US food supply, cosmetics, and products that emit 
radiation.  
Forgotten Joint 
Scale (FJS-12) 
A patient reported outcome (PRO) tool to provide a more patient-centered 
view on treatment outcome. The goal of this tool is to assess a patient’s ability 
to forget the artificial joint in everyday life.  
Good Clinical 
Practice (GCP) 
A standard for the design, conduct, performance, monitoring, auditing, 
recording, analyses, and reporting of clinical studies that provides assurance 
that the data and reported results are credible and accurate, and that the rights, 
integrity, and confidentiality of trial Subjects are protected. 
Harris Hip Score 
(HHS)  
Harris Hip Score (HHS) questionnaire is a tool used to assess the results of 
hip surgery and is intended to evaluate various hip disabilities. The HHS is a 
clinical-based outcome measure administered by a qualified health care 
profession, such as the Principal Investigator (PI) or Sub-Investigator (SI).  
Health Insurance 
Portability and 
Accountability Act 
(HIPAA) 
Federal legislation, applicable to US sites, Title II of which (in this context) 
is intended to help people keep their information private, and to address the 
security and privacy of health data. The legislation requires the establishment 
of national standards for the handling of health care information.  
Hip Disability and 
Osteoarthritis 
Outcome Score 
(HOOS)  
A 40-item questionnaire that is used to assess patient-relevant outcomes in 
five separate subscales (pain, symptoms, activity of daily living, sport and 
recreation function and hip related quality of life). The HOOS is a patient 
reported outcome (PRO).   
Informed Patient 
Consent Document 
(IPC) 
An explanation of all relevant aspects and risks of the proposed study, 
provided in appropriate language so that the Subject can understand and 
determine whether they wish to participate. See ISO 14155 and 21CFR50. 
Independent 
Radiographic 
Reviewer (IRR) 
An IRR will be used to review radiographic outcomes to help minimize bias 
in radiographic evaluations. 

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Institutional Review 
Board (IRB) 
Institutional Review Board (IRB) is a board, committee, or other group 
formally designated by an institution to review, to approve the initiation of, 
and to conduct periodic review of biomedical research involving human 
Subjects. The primary purpose of such review is to assure the protection of 
the rights, safety, and welfare of human Subjects. The IRB should be 
established, operated, and function in conformance with 21 CFR 56. The 
term has the same meaning as "institutional review committee" in section 
520(g) of the FD&C Act or “Ethics Committee” in other jurisdictions. 
Internationally, this entity may be referred to as an Ethics Committee (EC) 
or Research Ethics Board (REB). 
Investigator’s Site 
File (ISF)  
(or the Site’s Study 
Binder) 
Binder provided to the Principal Investigator by the Sponsor and maintained 
by the Investigational Site. The binder includes regulatory documents, 
IRB/REB/EC documents, correspondence, Investigator’s responsibilities, 
study protocol correspondence, Investigators Curriculum Vitae (CV), and 
other contents deemed applicable by the Sponsor.  
International 
Standard 
ISO 14155 
ISO (the international Organization for Standardization) is a world-wide 
federation of national standards for clinical investigation of medical devices 
for human subjects. ISO14155 addresses good clinical practice for the 
design, conduct, recording and reporting of clinical investigations carried out 
in human subjects to assess the safety or performance of medical devices for 
regulatory purposes.  
Patient Activity 
Tracking 
Patient Activity Tracking, for the purposes of this study, is a mobile, 
wearable watch-like device, will be used to gather passive and actively 
reported aspects of Subject recovery, pain management, activities of daily 
living (ADLs) and function directly from participating Subjects from the time 
of consent preoperatively through 3-months postoperatively.  
A smartphone (e.g., Android or iPhone) is required to receive the download 
of the ActiTrak™ mobile application (app). If a study Subject wants to 
participate and does not have a smartphone, the Sponsor can provide an 
android type tablet for study use only that will be returned at the 3-month 
postoperative visit.  
Clinical or Principal 
Investigator (PI), or 
Investigator  
Clinical Investigator is interchangeable with Principal Investigator (PI) 
and/or Investigator and is the individual at an Investigational Site qualified 
by training and experience who has overall responsibility for the conduct of 
a clinical investigation at that Site. This individual supervises the Site’s team 
and is responsible for authorizing and delegating duties. 
Research Ethics 
Board (REB)  
Alternate term for Institutional Review Board (IRB) or Ethics Committee 
(EC) - see above.  

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Source Documents 
Original documents, data and records (e.g. hospital records, clinical and 
office charts, laboratory notes, radiographs, other Subject information, etc.) 
that document Subject care and associated procedures in a clinical 
investigation. Also, called Source Documentation. 
Sub-Investigator 
(Sub-I) 
The Sub-Investigator (SI) is an individual at an investigational site qualified 
by training and experience to carry out the protocol, and whose activities 
relative to the protocol are supervised by the PI. 
 

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6 
SUBJECT MANAGEMENT STUDY SCHEDULE  
e-CRF Name 
Event / Visit 
Pre-op 
Operative 
6 Week 
3 Month 
Minimum 
1 Year 
Minimum  
2 Year 
-180 to 
DOS 
-90 to 
DOS 
 
Day 0 
 
28-70 d 
 
71-132 d 
 
304-668 d 
 
669-1763 d 
N/A 
Complete Screening Log 
 
3 
 
 
 
 
 
N/A 
Obtain Informed Subject Consent 
 
3 
 
 
 
 
 
N/A 
Verify Inclusion / Exclusion Criteria 
 
3 
 
 
 
 
 
eCRF DM 
Subject History 
 
3 
 
 
 
 
 
eCRF HH 
Harris Hip 
 
3 
 
3 
3 
3 
3 
eCRF HE 
Hip Evaluation 
 
3 
 
3 
3 
3 
3 
eCRF HOOS 
HOOS 
 
3 
 
3 
3 
3 
3 
eCRF FJS 
Forgotten Joint Scale (FJS-12) 
 
 
 
3 
3 
3 
3 
eCRF SG 
Operative Details (Total or Hemi)  
 
 
3 
 
 
 
 
eCRF DX 
Device Log 
 
 
3 
 
 
 
 
eCRF PA 
Patient Activity Tracking (ActiTrak™) 
This Optional portion of the study was 
completed upon the enrollment of 225 
THAs (i.e., June 5, 2017) 
 
3 
3 
3 
3 
 
 
eCRF UNS 
Unscheduled Visit Report * 
(Interim Visit) 
 
 
 
3 
3 
3 
 
eCRF AE 
Adverse Event 
 
 
3 
3 
3 
3 
3 
eCRF DS 
End of Study (Withdrawal) Form** 
 
 
 
3 
3 
3 
3 
Operative Side 
Radiographs 
AP Femur  
3 
 
3 
3 
3 
3 
Lauenstein Lateral 
3 
 
3 
3 
3 
3 
 
 AP Pelvis (for leg length discrepancy) 
3 
 
3 
3 
3 
3 
N/A 
Advise Subject of next visit  
 
3 
3 
3 
3 
3 
 
*To be completed, as applicable, when Subjects return for an unplanned or unscheduled visit between the protocol-defined windows.       
  
**The End of Study /Withdrawal Form to be completed for all Subjects to document a premature withdrawal or designate end of study/minimum 2-year final endpoint has been completed. 

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7 
INTRODUCTION 
Hip replacement, or arthroplasty, is a surgical procedure in which the diseased or damaged parts of the 
hip or hip joint are removed and replaced with prosthetic implants in the proximal femur (stem) and 
the acetabulum (cup or shell). The most common reason that people have hip replacement surgery is 
the wearing out of the hip joint as a result of osteoarthritis. Other conditions, such as rheumatoid 
arthritis (a chronic inflammatory disease that causes joint pain, stiffness and swelling), avascular 
necrosis (loss of bone caused by insufficient blood supply), injury (such as fracture), and bone tumors 
also may lead to breakdown of the hip joint and the need for hip replacement surgery.   
 
Hip replacement surgery is a reproducible surgical procedure with long-term implant survival. The 
Actis® Total Hip System is designed to include total hip replacement surgery and is an implant 
optimized for the anterior (surgical) approach. The anterior approach is a muscle sparing approach, 
which may allow for faster patient recovery, less pain and complications after surgery, better 
component placement, and the potential for lower postoperative dislocation and leg length 
discrepancies. The anterior approach can be performed on a standard operating or fracture table or with 
the use of a specialized orthopaedic table (e.g. HANA Table) that facilitates femoral exposure.  
 
The Actis® Total Hip System is designed to also include hemi-hip (Hemi) arthroplasty, a surgical 
procedure which replaces one half of the joint with an artificial surface and leaves the other part in its 
natural (preoperative) state. This class of procedure is most commonly performed on the hip after a 
sub-capital (just below the head) fracture of the neck of the femur (a hip fracture). The procedure is 
performed by removing the head of the femur and replacing it with a metal hip prosthesis (or hip stem). 
 
The Actis® Total Hip System consists of a wide range of stem neck designs and sizes allowing an 
accurate anatomical match for each patient. A list of compatible femoral heads and acetabular cup 
components are listed in Appendix E.   
 
The following information describes the study to be conducted for Actis® Total Hip System. The 
demonstration of the stability and performance specific to the Actis® Total Hip System medial collared 
DUOFIX® hip stem is important to survivorship and efficacy of this hip system.     
8 
RATIONALE  
The purpose of this study is to gather information regarding the function, performance and safety of 
the Actis® Total Hip System (Featuring DUOFIX® Technology).  
This is not a hypothesis driven study.  Instead it is designed to evaluate clinical outcomes (i.e., Harris 
Hip Score) with an adequate margin of error, radiographic outcomes and an estimate of device 
survivorship (please also refer to Section 16).  

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8.1 
Duration of Study 
The estimated duration of the overall clinical study is 3-years: 1-year for enrollment and 2-years for 
postoperative follow-up.  Although, it is expected that the hemi-hip arthroplasty cohort may take longer 
than 1-year to enroll. At the minimum 2-year visit, an End of Study eCRF will be completed for every 
study Subject who has not been prematurely withdrawn, and study participation will conclude.  
9 
SUBJECT DEFINITION  
9.1 
Subject Population 
For the purpose of this study, a “Subject” is defined as an individual who participates in the study as a 
recipient of the product (i.e., Actis® Total Hip System). Note: before Informed Patient Consent is 
obtained, a Subject may be referred to as a “patient”. 
9.2 
Subject Screening 
All patients who present for cementless primary total hip arthroplasty (THA) or a hemi-hip arthroplasty 
who generally meet the study requirements are potential candidates. Potential study patients should be 
screened for eligibility and listed on the Screening and Enrollment Log (to be provided by the Sponsor) 
in order to document that the patient selection was unbiased. The date of screening, the results of patient 
screening (included or not) and the primary reason for not including the patient (e.g., does not satisfy 
eligibility criteria) will be recorded on this log. Acceptance or declination of participation in the optional 
Patient Activity Tracking will also be captured on this log. The original log is to be retained at the Site 
and a copy sent to the Sponsor regularly during enrollment.   
9.3 
Subject Eligibility (Inclusion and Exclusion Criteria)  
The eligibility criteria for inclusion into this clinical investigation are consistent with the approved 
labeling for the Actis® Total Hip System.  Subjects qualify for treatment with the Actis® Total Hip 
System if they sign consent, and meet inclusion criteria and none of the exclusion criteria described 
below.  Subjects who have qualified for study treatment will also have the opportunity to participate in 
the parallel and optional Patient Activity Tracking portion of the study.  Declining participation in 
Patient Activity Tracking will not preclude the study Subject from otherwise participating as long as 
all other eligibility criteria are met.  Specific information regarding the Patient Activity Tracking device 
and the ActiTrak™ mobile application are provided in Appendix G and is also disclosed in the 
informed patient consent (IPC) document (Appendix B).   
The femoral stem component of the Actis® Total Hip System is optimized for use with the Anterior 
Approach (AA). However, if an eligible Subject has an implantation of the Actis® Total Hip System 
femoral stem and an anterior surgical approach (AA) has not been utilized the Subject will remain a 
study Subject and be followed per protocol. These non-anterior approach data will be analyzed as a 
cohort population.   

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Subjects who have an existing contralateral total hip replacement greater than 6 months 
postoperatively at the time of consent may be entered into this study if they qualify based upon the 
eligibility criteria and the approved labeling requirements. Simultaneous or staged bilateral patients 
utilizing the Actis® Total Hip System, or any hip system, are not allowed in this study (see Exclusion 
Criterion #8). 
9.4 
Inclusion Criteria: 
The Actis® Total Hip System is indicated for cementless use only, and this is as noted in the package 
labeling (i.e., Instructions for Use/IFU will be in each Actis® Total Hip System package). Subjects 
must meet at least one inclusion criterion for either total or hemi-hip arthroplasty.  
 
Total primary hip replacement is indicted in the following conditions:  
1. A severely painful and/or disable joint from osteoarthritis, traumatic arthritis, rheumatoid 
arthritis, or congenital hip dysplasia. 
2. Avascular necrosis of the femoral head. 
3. Acute traumatic fracture of the femoral head or neck.  
4. Certain cases of ankylosis.  
Hemi-hip arthroplasty is indicated in the following conditions:  
5. Acute fracture of the femoral head or neck that cannot be appropriately reduced and treated 
with internal fixation.  
6. Fracture dislocation of the hip that cannot be appropriately reduced and treated with internal 
fixation. 
7. Avascular necrosis of the femoral head. 
8. Non-union of femoral neck fractures. 
9. Certain high sub-capital and femoral neck fractures in the elderly. 
10. Degenerative arthritis involving only the femoral head in which the acetabulum does not require 
replacement. 
11. Pathology involving only the femoral head in which the acetabulum does not require 
replacement.  
Modular Femoral Heads and Acetabular Components: A DePuy modular femoral head is 
to be used with the DePuy femoral stem component. The acetabulum is to be replaced with a 
DePuy 2-piece metal-backed Ultra High Molecular Weight Polyethylene (UHMWPE) or all 
UHMWPE acetabular cup component with an inside diameter corresponding to the outside 
diameter of the modular femoral head that is utilized. 
 
Warning: Use only DePuy modular femoral heads with DePuy femoral stems. The taper size 
of the femoral head MUST be matched to the taper size of the femoral stem.  
 

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Further inclusion criteria for individuals who, in the opinion of the Principal Investigator, 
are suitable candidates for using the devices specified in this protocol and they are as follows:  
12. Individuals who can speak, read, and comprehend the informed patient consent (IPC) 
document, which is in English, and be willing and able to provide informed patient consent for 
participation in the study and have authorized the transfer of his/her information to DePuy 
Synthes. 
13. Individuals who are willing and able to return for follow-up as specified by the study protocol.  
14. Individuals who are a minimum age of 21 years at the time of consent.  
15. Individuals who are not bedridden: 
o The intent of “not bedridden” means a permanent situation, not a temporary situation as 
in a hip fracture or trauma case. 
16. Individuals who are willing and able to complete the Subject Hip Outcomes questionnaires (i.e., 
FJS-12, HOOS and Hip Evaluation) as specified by the study protocol. 
9.5 
Exclusion Criteria:  
Subjects will be excluded if in the opinion of the Investigator, the individual meets any of the 
following exclusions: 
 
1. Active local or systemic infection. 
2. Loss of musculature, neuromuscular compromise or vascular deficiency in the affected limb 
rendering the procedure unjustified. 
3. Poor bone quality, such as osteoporosis, where in the surgeon’s opinion, there could be 
considerable migration of the prosthesis or a significant chance of fracture of the femoral 
shaft and/or the lack of adequate bone to support the implant(s).  
4. Charcot’s or Paget’s disease.  
5. For hemi-hip arthroplasty, any pathological condition of the acetabulum, such as distorted 
acetabuli with irregularities, protrusion acetabuli (arthrokatadysis), or migrating acetabuli, 
that would preclude the use of the natural acetabulum as an appropriate articular surface for 
the hemi-hip prosthesis. 
6. The Subject is a woman who is pregnant or lactating. 
7. Existing contralateral hip that was implanted less than 6 months from the date of surgery at 
the time of consent into this study.  
8. Subjects requiring a simultaneous bilateral hip at the time of consent will be excluded; 
there can be only one Actis® study hip. This also means that even if another hip system is 
used for the contralateral hip during simultaneous THAs, the Subject will be excluded. As 
noted above, Subjects who have an existing contralateral total hip replacement greater than 

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6 months postoperatively at the time of consent may be entered into this study if they qualify 
based upon the eligibility criteria and the approved labeling requirements. 
9. Subject had a contralateral amputation. 
10. Subject has participated in a clinical investigation with an investigational product (drug or 
device) in the last three months. 
11. Subject is currently involved in any personal injury litigation, medical-legal or worker’s 
compensation claims regardless of body system. 
12. Subject, in the opinion of the Investigator, is a drug or alcohol abuser or has a psychological 
disorder that could affect their ability to complete patient reported questionnaires or be 
compliant with follow-up requirements. 
13. Subject was diagnosed and is taking prescription medications to treat a muscular disorder 
that limits mobility due to severe stiffness and pain such as fibromyalgia or polymyalgia. 
14. Subject has a medical condition with less than 2 years of life expectancy. 
Note: Diabetes, at present, has not been established as a contraindication. However, because 
of the increased risk for complications such as infection, slow wound healing, etc., the 
physician should carefully consider the advisability of hip replacement in the severely 
diabetic patient.  
Caution: Implants and trial components from different manufacturers or implant systems 
should never be used together.  
9.6 
Enrollment & Subject Identification (ID) Number 
A study Subject is enrolled when they have been properly consented. Once consent is obtained, the 
Subject must be added to the study electronic data capture (EDC) system, which will automatically 
generate a unique Subject number.  The first two digits of the Subject number represent the site 
identification number, followed by a hyphen, and three digits representing the sequential identification 
(e.g., Subject 10-001 is the first subject enrolled at site 10). The Subject’s unique identifier assigned in 
EDC will be recorded on each page of the eCRF and all other clinical investigation documentation 
relating to that Subject.  
 
Study-specific Subject questionnaires should not be completed until the study Subject has signed and 
dated the Informed Consent Document and has met all other eligibility criteria. Additionally, a Subject 
must meet the eligibility criteria in order to participate in the optional Patient Activity Tracking 
(ActiTrak™) part of the study.  
 
The Principal Investigator must document the Subject’s participation in this study in the Subject’s clinic 
and hospital notes.   

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10 OBJECTIVE AND ENDPOINTS 
10.1 
Primary Objective 
Two-year (2 year) information regarding the performance of the commercially available Actis® Total 
Hip System in order to obtain and evaluate the clinical outcomes on a series of cementless primary 
total hip arthroplasty (THA) and hemi-hip arthroplasty using clinical, radiographic and device and 
procedure related adverse event assessments.  
10.2 
Primary Endpoint  
Investigate the minimum 2-year postoperative functional performance for the Actis® Total Hip System 
as measured with the Harris Hip Score at minimum 2 years postoperatively for cementless primary 
total hip arthroplasty.  All analyses including the primary endpoint analysis will be conducted on 
primary THA subjects and a summary for hemi-hip arthroplasty Subjects will be provided separately.  
10.3 
Secondary Endpoints  
x Harris Hip score at 3-months and 1-year 
x Radiographic evaluation at 2-years postoperatively, inclusive of leg length discrepancy  
x Type and frequency of AEs through 2-years postoperatively 
x Device survivorship at 2-years postoperatively 
10.4 
Tertiary Endpoints 
x Change in Subject Outcomes (i.e., FJS-12, HOOS and Hip Evaluation) will be measured and    
compared from preoperative to 6-weeks, 3-months, minimum 1-year and minimum 2-years. 
x Patient tracking activities reported from the mobile ActiTrak™ application will be analyzed for 
pain, location of pain, mood/emotion, and activities of daily living and range of motion. Subject 
Satisfaction will be asked periodically after surgery. The range of time for these tertiary endpoints 
will be from the time of consent preoperatively through 3-months postoperatively.   
10.5 
Study Design 
A prospective, uncontrolled, non-randomized, multi-center study with a total of 255 Subjects to include 
a minimum of 225 Primary THA Subjects and a cohort with a minimum of 30 hemi-hip arthroplasty 
Subjects. All Subjects will be seen for a preoperative clinic visit at the time of consent, during surgery, 
and then at 6-weeks, 3-months, minimum 1-year, and minimum 2-years postoperatively.  
 
Each site is expected to implant the number of Subjects as outlined in their clinical trial agreement; 
however, cohort reallocation (no greater than 40 Subjects per site) is permitted in order to meet 
timelines. Details regarding sample size are presented in Section 16.9.  

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10.6 
Optional (Electronic) Patient Activity Tracking Device 
This clinical investigation will provide the opportunity for Subjects who are properly consented and 
deemed eligible for the study to join in a parallel and optional portion of the study – to electronically 
capture real-time patient activities of daily living (such as pain, location of pain, mood/emotion, 
activities of daily living and range of motion, Subject satisfaction will periodically be asked after 
surgery) from the time of consent preoperatively to 3-months postoperatively. If a Subject is unable or 
unwilling to provide the preoperative data, this will not preclude or delay them from enrollment. 
Subjects may also enroll in the Patient Activity Tracking on the day of their surgery and collect 
activities through the 3-month postoperative visit interval. This optional part of the study will be open 
for enrollment until 225 THA Subjects are treated; then, this part of the study will be closed. The 
fulfillment of 225 THA Subjects occurred June 5, 2017 and this portion of the study has now concluded 
with Version B of the protocol.   
Patient Activity Tracking is a combination of a wearable watch-like device and a mobile application, 
specifically, the ActiTrak™ application. The wearable watch-like Patient Activity Tracking device will 
be linked (i.e., electronically synced) to a downloaded mobile application (app) on the Subject’s own 
well-functioning (and updated to the most current operating system version) smartphone. If the Subject 
does not have a smartphone the Sponsor can provide an Android tablet to help Subjects continuously 
track their postoperative outcomes in their natural environment, in real-time, and in a non-invasive 
manner. This type of patient direct data collection can improve data quality and method of collection 
and is potentially more sensitive to the changes in activities preoperatively compared to postoperatively 
(e.g., not burdensome or possibly inconclusive like a paper diary). 
Study sites and study Subjects are not required to join in the optional portion of the study.  
For those eligible study Subjects who chose to participate, the wearable Patient Activity Tracking 
device will be provided to them by the study site (which has been provided by the Sponsor) and will 
be returned at the 3-month visit. The mobile ActiTrak™ app will linked to their smartphone (or the 
Sponsor provided Android tablet as noted above) via a downloaded mobile app. The linking of the 
Patient Activity Tracking device to the ActiTrak™ app on a smartphone or Android tablet is required 
in order for the collected data to securely import into the study’s EDC system. 
The combination Patient Activity Tracking device and the ActiTrak™ app will be used to passively 
(automatically) as well as objectively (manual or active Subject entries into a downloaded mobile 
application on either a smartphone or Android tablet) in order to collect activities of daily living. Some 
questions will occur weekly and others only monthly. Appendix G provides guidance and support for 
study sites and Subjects. 
10.7 
Study Database 
The study database has been validated in accordance with 21 CFR Part 11, European Commission’s 
Directive on Data Protection and US Safe Harbor Certification. Prior to being released for importation 
of patient activity and study data, validation of the study level components will be conducted in 

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accordance with approved user acceptance testing procedures. Access to this system will be controlled 
so that only authorized users will have the ability to enter into the system. The system is considered a 
closed system according to 21 CFR Part 11 Electronic Records; Electronic Signatures.   
10.8 
Treatment Assignment 
The Actis® Total Hip System is the only construct of interest in the study; there will be no control 
group. This is applicable to the treatment of both total and hemi-hip arthroplasty.  
11 RADIOGRAPHS 
This study will accept radiographs for the preoperative interval taken prior to the study Subject’s 
participation in this study up to -180 days before surgery as long as the radiographs meet the three 
protocol required views: Antero-Posterior (AP) Pelvis, AP Femur and Lauenstein Lateral. The -180 
days preoperative is allowed to minimize a study Subject’s unnecessary exposure to radiation. Further 
radiographic details are provided in Appendix D. 
 
Leg length discrepancy (LLD) will be recorded by the independent radiographic reviewer (IRR) via 
the radiographs on the Hip Evaluation eCRF (and, optionally by the Principal Investigator, See Section 
16.12 Secondary Endpoints).  
12 SUBJECT EVALUATIONS  
12.1 
Summary of Subject Evaluations 
Diagnostic, demographic and operative information, clinical follow-up and applicable unscheduled 
(i.e., unplanned or unscheduled that occur between the protocol defined visit windows) visits for each 
enrolled Subject will be documented on electronic case report forms (eCRFs) which have been 
developed specifically for this study.  Subject completed Patient Reported Outcomes or PROs will be 
completed on source by the study Subject and then entered by the study site into the EDC system.  The 
eCRF details that are to be used to collect and evaluate study Subject outcomes preoperatively, intra-
operatively and postoperatively are listed below in Table 4.  Patient reported outcomes (shaded in light 
blue) will be provided in hard copy (i.e., paper) printed sets for completion by the study Subject during 
the clinic visit.  Study sites should not enter any data into the EDC system until each potential patient 
has signed consent and is considered enrolled (Section 15 defines the consent process and Section 9.1 
defines the Subject population).  
 
 
 
 
 

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12.2 
Table 4 Summary of Subject Evaluation and eCRFs 
Table 4 Summary of Subject Evaluations and eCRFs 
Subject History  
eCRF DM 
Demographic and study entry criteria are documented on Subject History.  
The preferred timing of the Informed Consent process and preoperative 
data collection (with the exception of the preoperative radiographs – see 
Section 11) is from -90 to -1 days of the surgical event. 
Harris Hip 
Evaluation 
eCRF HH 
The Harris Hip Evaluation will be used to clinically assess each Subject at 
the preoperative and postoperative intervals specified in Section 6 Subject 
Management Study Schedule. 
 
Contained in Section H, Leg length, of the eCRF HH there is an OPTION 
to provide a measurement of each leg (surgical and non-surgical) pre- and 
postoperatively. This option applies to both cohorts: THA and hemi-hips. 
If manual leg length measurements are taken, there are checkboxes in 
Section H to record the measurement method: “Apparent”, “True” and 
“Other”.  
 
The “Apparent” manual method is measured using a tape measure from 
the umbilicus to the medial malleolus.  
 
The “True” manual method is measured using a tape measure from the 
anterior superior iliac spine to the medial malleolus (Sabharwal).  
 
“Other” consistent and repeatable LLD measurements are acceptable as 
per each study sites’ standard of care.  
 
If leg length is manually measured and reported pre-operatively for a 
Subject, please be consistent and collect it for the entire study for analysis. 
Leg length discrepancy (LLD) will be analyzed (Section 16.12) as a 
secondary endpoint.     
Hip Evaluation 
eCRF HE 
Subjects will complete a hip outcomes self-assessment, which includes 
questions about their satisfaction and hip function starting at the 
preoperative interval.   
 
HOOS 
eCRF HOOS 
Subjects will complete this hip outcomes self-assessment, which includes 
40 questions about their activities of daily living and more advanced sports 
and recreational activities starting at the preoperative interval.   

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Forgotten Joint Scale 
(FJS-12) 
eCRF FJS 
Subjects will complete this hip outcomes self-assessment, which includes 
12 questions about their awareness of their (operative) hip joint and their 
ability to ‘forget’ the artificial joint in everyday life.  
Pre- and 
Postoperative Hip 
Radiographic 
No eCRF for Study 
Site  
Radiographic guidelines are provided in Appendix D.  
 
High quality Antero-Posterior (AP) Femur, AP Pelvis and Lauenstein 
Lateral radiographs of the operative hip will be obtained during the same 
preoperative and postoperative follow-up intervals as for the clinical 
evaluations. All original radiographs will be retained by the site and digital 
copies will be sent to the Sponsor through a web-based application. 
Alternate methods to submit radiographs to Sponsor must be pre-arranged. 
Analysis of the radiographs by an Independent Radiographic Reviewer 
(IRR) will involve the use of a web-based application.  
 
Observations by the IRR will be documented on the radiographic eCRF 
(radiographic eCRF is not provided to study sites) and entered into the 
study radiographic database by the IRR. 
Operative Details 
eCRF OP 
For all Subjects, detailed information related to the primary diagnosis, 
anesthesia type and time, if a fracture table (e.g., HANA Table) was 
utilized, and surgical exposure (e.g., anterior approach), and other surgical 
data will be recorded on the Operative Details eCRF – this includes 
primary total hip arthroplasty and hemi-hip arthroplasty. 
Device Log 
eCRF DX 
Labels for each component/device used during the procedure must be 
recorded.  
Unscheduled Visit 
Report 
(unplanned or 
interim) 
 
eCRF UNS 
An unscheduled office visit is defined as any visit at the study site where 
a study subject is seen by one of the site staff including the principal 
Investigator (PI), any Sub-investigator (as appropriate), and anyone 
identified on the PI’s team, outside of the scheduled study visit. An 
unscheduled visit is only to be reported when the visit falls between study 
intervals as described in Section 6 Subject Management Study 
Schedule.  An unscheduled visit eCRF is not to be completed if the 
Subject comes in for additional, unplanned visits within the in-
window study interval. 
 
If the previous protocol defined study interval visit was missed, the 
required eCRFs/CRFs in the previously missed interval visit are also 
required along with the unscheduled visit eCRF.  
 

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If an unscheduled visit is related to a new, worsening, or resolved adverse 
event, both an AE eCRF and the unscheduled visit eCRF are completed.  
Adverse Event (AE) 
eCRF AE 
In the event of a postoperative AE the details will be captured on an AE 
eCRF. Only one AE can be recorded on an AE eCRF.  
 
An AE can be defined as Mild, Moderate or Severe and these terms are 
defined in Section 13 (The definitions of Serious Adverse Event and 
Unexpected Adverse Device Event or UADE are defined in Section 13).  
 
For a worsening AE, please resolve the previous AE on eCRF and report 
a “New” AE eCRF for the new Severity.  
Patient Activity 
Tracking 
(ActiTrak™) 
 
eCRF PA 
The Patient Activity Tracking device is a wearable watch-like device that 
will be linked with the ActiTrack™ app that is downloaded on to a 
Subject’s own smartphone (iPhone or Android phone, or Sponsor provided 
Android tablet) and will be used at some sites. It is not mandatory for a 
study site or a study Subject to participate. For details on the Patient 
Activity Tracking device (i.e., the wearable watch-like device) and the 
required downloaded mobile app, refer to Appendix G.  
 
Preoperatively at from the time of consent through 3 months 
postoperatively is the preferred timeline for participation.  
 
Data collected via the Patient Activity Tracking is a part of the tertiary 
endpoints (Section 16).  
End of Study/ 
Withdrawal 
 
eCRF DS 
 
 
 
Please complete the End of Study eCRF when a study Subject has either 
completed the study primary endpoint (2-year follow-up) or for any reason 
for withdrawal; some examples are listed below:   
x Withdrawal of consent 
x Investigator decision 
x Death (correlate with AE eCRF) 
x Lost to follow-up 
x General screen failure (includes intra-operative screen failures)  
x Study site withdrew/terminated from study 
x Adverse event related (including revisions postoperative, correlate 
with AE eCRF)  
x Other reasons – specify  
x Revision (correlate with AE eCRF)   
x Completion of final endpoint at minimum 2 years 

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NOTE:  AE eCRF will be completed for only device and procedure related 
AEs. For further details and directions regarding revision of any study 
component please also refer to Table 8 Revisions and Reoperations.  
All screen failures (SFs) are to be reported on the Screening and 
Enrollment Log (Log will be provided by the Sponsor).  
12.3 
Actions for Screen Failure Subjects 
Subjects can be a screen failure prior to surgery (e.g., withdraw of consent) or be considered a screen 
failure when withdrawn intra-operatively; intra-operative screen failure could be due to the Subject 
requiring a non-study implant. Table 5 below provides further examples of screen failures and required 
actions.  
12.4 
Table 5 Actions for Screen Failure Subjects 
Table 5 Actions for Screen Failure Subjects 
(Based on the definition of an Enrolled Subject in Section 9) 
Screen 
Failure 
Type 
Screening/ 
Enrollment 
Log? 
Data 
submitted 
To EDC? 
Enrolled 
Subject? 
Example 
 
Action 
Pre-
operative 
screen 
failure 
Yes 
Yes 
Yes 
Subject signed IPC, 
meeting the 
definition of 
enrolled, but has 
withdrawn consent 
before surgery or 
no longer meets 
inclusion/exclusion 
criteria at time of 
surgery 
Document on Screening & 
Enrollment Log as 
Preoperative Screen 
Failure 
 
Complete & enter 
Preoperative eCRFs if 
data was collected: DM, 
HH, HE, HOOS and DS  

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12.5 
Actions for Postoperative Withdrawals 
A postoperative withdrawal is a Subject who signed the IPC document, was implanted with the study 
device, and is later withdrawn from study participation (i.e., withdrawal of consent, revision of femoral 
or acetabular components, death, etc.). Table 6 provides examples and the actions and eCRF(s) to be 
completed at the time of withdrawal.   
 
All data up to date of withdrawal will be included in the clinical analysis.  
12.6 
Table 6 Actions for Postoperative Withdrawal 
Table 6 Actions for Postoperative Withdrawal 
Example 
Actions 
Follow -up 
Subject 
withdraws 
consent  
x Document Subject’s request for withdrawal from 
the study in the source 
x Complete End of Study/Withdrawal eCRF  
x Update Screen/Enrollment Log 
Do not  
continue 
Death 
x Document in source  
x Complete Adverse Event eCRF 
x Complete End of Study/Withdrawal eCRF 
x Update Screen/Enrollment Log 
Do not  
continue 
Revision  
See Section 14.5, Table 9 Revisions and 
Reoperations 
Do not continue if the 
femoral stem has been 
removed or revised.   
Intra-
operative 
screen 
failure 
Yes 
Yes 
Yes 
Subject signed IPC, 
meeting the 
definition of 
enrolled, but it was 
determined during 
surgery that the 
Subject would not 
have the Actis® 
Total Hip System 
implanted 
Document on Screening & 
Enrollment Log as Intra-
operative Screen Failure 
 
Complete & enter 
Preoperative & Operative 
eCRFs if data was 
collected:  DM, HH, HE, 
HOOS, PA and DS 
Overall, the number of study Subjects implanted with the Actis® Total Hip System, across all study 
sites, must meet the total sample size of 255 Subjects that includes a minimum of 225 Primary THA 
Subjects and a cohort of a minimum of 30 hemi-hip arthroplasty Subjects.  Meaning, you can replace 
Subjects who have screen failed prior to implantation.  

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Please continue to follow 
if the femoral component 
has not been removed or 
revised  
13 ADVERSE EVENTS (AES) 
An adverse event (AE) is defined as an untoward medical occurrence, unintended disease or injury, or 
untoward clinical signs (or change or worsening of a pre-existing medical condition) in a patient, which 
may or may not have an association with the device. In addition, an adverse device effect is defined as 
“any untoward and unintended response to a medical device”. Further types of AEs and definitions are 
in Table 7 below. AEs are reported beginning from when the informed consent is signed until Subject 
participation has ended (study completed or consent withdrawn.  This protocol requires each site to 
report AEs to their respective IRB/REC, EC, per their IRB/REB/EC’s respective requirements. Device 
related AEs will be reviewed by DePuy Synthes and reported, if applicable, to the appropriate 
regulatory body.  
 
Study Sites have two (2) weeks from when they become aware of device and /or procedure related AEs 
to inform the Sponsor via the AE eCRF.  
 
For this study, only the AEs related to the study devices (excluding the Patient Activity Tracking 
devices) or the procedure are to be reported (please refer to Figure 13.1). The determination 
whether the AE was related to the device or procedure will be based upon whether a causal relationship 
between the device or procedure and the AE is at least a reasonable possibility, i.e., the relationship 
cannot be ruled out. A causal relationship cannot be ruled out if, in the medical judgment of the 
Investigator, the effect follows a reasonable temporal association with the use of the device and/or is 
confirmed by the improvement of the effect upon discontinuation of the clinical use of the device, 
and/or the effect is not reasonably explained by the Subject’s clinical state.  
 
A record of each device or procedure related AE, including details of the nature, onset, duration, 
severity, relationship to the device, relationship to the operative procedure and outcome, will be made 
on an AE eCRF. Subjects must be questioned about any new or changed AEs at each subsequent 
follow-up visit, whether scheduled or not. 
 
AEs must be followed to resolution, or end of subject’s study participation. When a Subject ends 
participation in the trial, all open AE outcomes must be designated in the AE eCRF as either 
“Recovered/Resolved with no residual effects”, “Recovered/Resolved with residual effects”, 
“Ongoing”, “Death”, or “Unknown” providing a resolution date (if applicable) or ongoing designation.  

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There is no personal benefit to the Subject for participation in this study.  However, data collected in 
this study will contribute to the safety profile of the Actis® Total Hip System.  
 
Figure 13.1: AE Reporting flowchart illustrates a series of question a site must consider when 
determining whether a given clinical observation must be reported and which AEs do not need to be 
reported for this study.  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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Clinicial Observation
Is the new condition 
related to the Study 
Device or Procedure? 
DO NOT REPORT
Is this an SAE?
YES
Complete AE 
eCRF
SAEs and UADEs require 72 hour 
reporting to Sponsor. IRB/Ethics 
notification are as per local 
requirements  
NO
YES
Site to Report to 
Sponsor 2 weeks 
from when they 
become aware
YES
NO
 
 
Adverse Events (AEs) occurring postoperatively after hip arthroplasty are not unique to the Actis® 
Total Hip System and are like those that may occur with any THA or hemi-hip arthroplasty.  And, per 
Figure 13.1 AE Reporting Flowchart 

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the Instructions for Use (IFU), which is included in the implant packaging, the following are generally 
the most frequently encountered AEs and complications in hip arthroplasty. 
 
General:  
1. Change in position of the prosthetic components, often related to the factors listed in 
WARNINGS AND PRECAUTIONS.  
2. Early or late loosening of the prosthetic components, often related to factors listed in 
WARNINGS AND PRECAUTIONS.  
3. Fatigue fracture of the femoral stem, often related to factors listed in WARNINGS AND 
PRECAUTIONS. 
4. Excessive wear or fracture of the bearing components due to: intra-operative damage to the 
prosthetic components, loose cement, bone fragments, metallic particles, ceramic particles or 
other factors listed in the WARNINGS AND PRECAUTIONS. 
5. Early or late infection. 
6. Peripheral neuropathies, Subclinical nerve damage may also occur as a result of surgical 
trauma. 
7. Tissue reactions, osteolysis, and/or implant loosening caused by metallic corrosion, allergic 
reactions, wear or particulate debris (such as loose cement, metallic, polyethylene or ceramic 
particles).  
Intra-operative: 
1. Acetabular perforation. 
2. Femoral shaft perforation, fissure, or fracture, which may require the use of internal fixation. 
3. Trochanteric fracture. 
4. Damage to blood vessels (e.g., iliac, obturator and femoral artery).  
5. Temporary or permanent nerve damage (e.g., femoral, obturator or isolated peroneal nerve). 
6. Subluxation or dislocation of the hip joint due to implant size or configuration selection, 
positioning of components and/or muscle and fibrous tissue laxity. 
7. Breakage or chipping of the ceramic femoral head. 
8. Lengthening or shortening of the affected extremity.   

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Early Postoperative: 
1. Cardiovascular disorders including venous thrombosis, pulmonary embolism and myocardial 
infarction. 
2. Hematoma and/or delayed wound healing. 
3. Pneumonia and/or atelectasis. 
4. Subluxation or dislocation.  
Late Postoperative: 
1. Trochanteric avulsion from excessive muscular tension, weight-bearing, or inadvertent intra-
operative weakening of the trochanter. 
2. Aggravation of problems in the ipsilateral or contralateral knee and ankle joints due to leg 
length discrepancy, femoral medicalization and/or muscular deficiencies. 
3. Femoral or acetabular fracture due to trauma or excessive loading, particularly in the presence 
of poor bone stock caused by sever osteoporosis, bone defects from previous surgery, - reaming 
procedures, or bone resorption.  
4. Bone resorption which may contribute to the deterioration of fixation and eventual loosening 
of the implant. 
5. Peri-articular calcification or ossification which may lead to a decrease in joint mobility and 
range of motion.  
6. Traumatic arthrosis of the ipsilateral knee secondary to intra-operative positioning, of het 
extremity during surgery. 
7. Subluxation or dislocation.  
The incidence and severity of complications in hip replacement are usually greater in revisions than in 
primary operations. Common problems encountered in revision surgery may include difficulty in placement 
of the incision, removal of ectopic bone and old bone cement, positioning and fixation of components, and/or 
obtaining adequate bony support. In general, increased operative time, blood loss and risk of infection, 
pulmonary embolus and wound hematoma can be expected with revision procedures.    
 
WARNING: if postoperative breakage or chipping of the ceramic femoral head component is confirmed, 
surgery for its removal must be performed as soon as reasonably possible.  
 
 

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13.1 
Table 7 Definitions of Adverse Event (AE) Types, Device Deficiency. 
For this protocol, the term “expected” will be synonymous with the term “anticipated” and 
“unexpected” will be synonymous with “unanticipated”.  
 
Table 7 Definitions of Adverse Event (AE) Types, Device Deficiency 
Awareness (Date of AE Awareness) 
The day, month and year that the study site becomes 
aware of information from any source that reasonably 
suggests that an AE has occurred. 
 
Note: This date may or may not correspond to the date of 
onset. The date of awareness is critical to reporting 
timelines.  
Adverse Event (AE)  
AE is defined as an untoward medical occurrence, 
unintended disease or injury, or untoward clinical signs 
(or change or worsening of a pre-existing medical 
condition) in a patient, which may or may not have an 
association with the device. AE is synonymous with 
“complication” or “medical event”.  
Adverse Device Effect (ADE)  
ADE is defined as an Adverse Event related to the use of 
an investigational medical device. 
 
Notes: This definition includes adverse events resulting 
from insufficient or inadequate instruction for use, 
deployment, implantation, installation or operation, or 
any malfunction of the medical device under study. This 
definition includes any event resulting from user error or 
from intentional misuse of the medical device under 
study).  
Serious Adverse Device Effect (SADE) SADE is defined as an Adverse Device Effect that has 
resulted in any of the consequences characteristic of a 
serious adverse event. 
Serious Adverse Event (SAE)  
SAE is defined as an Adverse event that: 
x led to a death, 
x led to a serious deterioration in the health of the 
Subject that either: 
o resulted in a life-threatening illness or injury, 
or 
o resulted in a permanent impairment of a body 
structure or a body function, or 

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o required 
inpatient 
hospitalization 
or 
prolongation of existing hospitalization, or 
o resulted in medical or surgical intervention to 
prevent life threatening illness or injury or 
permanent impairment to a body structure or 
a body function. 
o led to fetal distress, fetal death or a congenital 
abnormality or birth defect. 
x Other serious important medical events. Report when 
the event does not fit the other outcomes, but the 
event may jeopardize the patient and may require 
medical or surgical intervention (treatment) to 
prevent one of the other outcomes.  
Examples of procedure related serious AEs (SAEs) may 
include: stiffness requiring manipulation of the hip under 
anesthesia, dislocation of hip requiring closed reduction, 
Deep Vein Thrombosis (DVT) without hospitalization.   
Examples of device related SAEs may include 
radiolucent lines around the femoral component or 
device dislocation.  
Unexpected/Unanticipated 
Adverse 
Device Effect (UADE)  
Is defined as any serious adverse effect on health or 
safety, or any life-threatening problems, or death, caused 
by, or associated with, a device, if that effect, problem, 
or death was not previously identified in nature, severity, 
or degree of incidence in the Clinical Investigation Plan, 
or application, or any other unanticipated serious 
problem associate with a device that relates to the rights, 
safety, or welfare of Subjects. A UADE will not be listed 
in the Instructions for Use (IFU).  
 
All potential UADEs that occur during this investigation 
must be reported by the Investigator no later than 72 
hours from the time when the Investigator is aware of 
the event to the Sponsor by telephone (800) 829-7003, 
electronic correspondence, or facsimile (574) 371-4950.  
 

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In the event of a UADE or serious adverse device effect, 
the Investigator should institute appropriate therapeutic 
and follow-up measures in accordance with good 
medical practice and notify the local IRB/REB/EC.  The 
Investigator must document follow-up treatment in the 
“comment” section of the AE eCRF.  A full written report 
of the event must be forwarded to DePuy Synthes within 
10 working days of the discovery. 
 
DePuy Synthes must notify FDA, all reviewing 
IRB/REB/EC’s 
and 
all 
participating 
Clinical 
Investigators of all UADEs within 10 working days of 
first receiving notice of the event.  In addition, the event 
will be reported to the DePuy Synthes Complaint 
Handling Unit (CHU) for investigation. 
Device Deficiencies  
Are defined as in adequacy of a medical device with 
respect to its identity, quality, durability, reliability safety 
or 
performance. 
Device 
deficiencies 
include 
malfunctions, use errors and inadequate labeling. Device 
deficiencies should institute appropriate therapeutic and 
follow-up measures in accordance with good medical 
practice and notify the IRB/REB/EC as applicable.  The 
Investigator must document follow-up treatment of the 
AE and the Sponsor will report the event to the DePuy 
Synthes Complaint Handling Unit for investigation. 
13.2 
Definition of AE Severity 
An adverse event (AE) or an adverse device effect (ADE) may be: 
x Mild: Easily tolerated and transient in nature with minimal or no impairment of normal activity. 
Intervention is not indicated. Clinical or diagnostic observations only and no impairment of 
normal activity.  
x Moderate: Poorly tolerated, sustained and interferes with normal activity and requires medical 
attention. Intervention is either noninvasive or not indicated. Activities of daily living can be 
sustained.  
x Severe: Poorly tolerated, requires intervention and significantly affects activities of daily life; 
or places the Subject at immediate risk or harm.  

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14 DETERMINATION OF RELATIONSHIP TO DEVICE AND/OR PROCEDURE AND ADES AND 
SADES 
14.1 
Device or Procedure Related 
As noted in Section 13, for this study, only the AEs related to the study devices or the procedure are 
to be reported and the determination of whether the AE is related to the device or procedure is based 
on the definition provided in that section.   
 
Relationship to study device or procedure should both be rated as follows: “Definitely”, “Probably”, 
“Possibly”, “Remote Possibility”, or “Definitely not”.  
 
Table 8 Definitions of Device-Relatedness and Procedure-Relatedness for AEs 
Term 
Description  
Definitely 
The relationship between study device or procedure and event does 
exist and is confirmed upon further investigation by the 
Investigator 
Probably 
The relationship between study device or procedure may exist if 
other causes are unlikely 
Possibly 
The relationship between study device or procedure could exist; 
however, other causes are possible 
Remote Possibility 
There is minimal chance that a relationship exists between the 
study device and/or procedure 
Definitely Not 
There is definitely no relationship between study device or 
procedure and the event 
14.2 
Worsening Adverse Events 
For a worsening AE, resolve the original AE on an AE eCRF and complete an additional AE eCRF for 
the new Severity. Examples of this exercise will be included in the eCRF Completion Instructions 
(CCIs), a tool which will be provided to site to help aid in entering data into the EDC system. A simple 
example is that if a Subject has a superficial wound infection with oral medication as a treatment that 
progresses to a deep wound infection with additional treatment (e.g., inpatient hospitalization for an 
irrigation and debridement). The study site must resolve the superficial wound infection and report the 
worsening on an additional AE eCRF. Each AE will be counted individually – as in one superficial 
wound infection and one deep wound infection AE/SAE.  
14.3 
Pre-existing Medical Conditions 
Pre-existing medical conditions or symptoms reported prior to device implantation are to be recorded 
as history and not to be recorded as AEs (e.g., History of Asthma or existing osteoarthritis in 
contralateral knee would be recorded on the Subject History eCRF). In the event there is an 

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exacerbation of the pre-existing medical condition or symptoms, related to the device or procedure, an 
AE must be reported. 
14.4 
Minimization of Risks 
The Sponsor will further minimize the identified and/or emergent risks throughout the study, by 
reviewing the reported complications and adverse effects.  Device related adverse events will be 
reviewed and reported to the FDA as part of the Medical Device Reporting (MDR) requirements 
(http://www.fda.gov/cdrh/mdr/). Based upon an evaluation of such events, the Sponsor may either 
amend the investigational plan or terminate the investigation to protect the rights, safety and welfare 
of the study Subjects. Investigators will be provided periodic reports of all adverse events. 
 
Should an IRB/REB/EC decide to suspend or withdraw its approval for a PI to conduct the study at 
that institution, based on unacceptable risks to the study Subjects, the study Sponsor will notify all 
reviewing IRB/REB/ECs, and PIs of this action.  To further minimize risks, any new information 
obtained during the course of the study relating to unanticipated adverse findings will be provided to 
all Subjects, PIs, and IRB/REB/ECs. 
 
The study has been designed to minimize the number of Subjects, yet provide sufficient numbers of 
Subjects for valid scientific analysis of the compiled study data.  The study design, the procedures for 
oversight and the documentation, reporting and evaluation of the results from its surgical use will 
further control risks. 
14.5 
Table 9 Revisions and Reoperations  
A “revision” is defined as a surgical procedure of the affected study hip where any Actis® Total Hip 
System component for any reason is removed. A revision algorithm specifically for this study is as 
follows:  
 
 
 
 
 
 
 
 
 
 
 
 
 

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Table 9 Revisions and Reoperations  
Component(s) 
revised/removed 
eCRFs to be completed 
Actions 
All 4 components removed: 
femoral stem and head, 
acetabular cup and liner 
AE eCRF 
End of Study eCRF 
Subject is revised and 
withdrawn from the study 
Exchange of only the 
polyethylene acetabular liner 
(only poly liners are allowed in 
the study) 
AE eCRF 
Subject is categorized as 
revised but not withdrawn from 
study 
Continue to follow through the 
2-year endpoint  
Removal of only the femoral 
stem and head (acetabular cup 
and liner remain in place)  
AE eCRF 
End of Study eCRF 
Subject is revised and 
withdrawn from the study 
Removal of only the acetabular 
cup and liner (femoral stem 
and head remain in place) 
AE eCRF  
Subject is categorized as 
revised but not withdrawn from 
study 
Continue to follow through the 
2-year endpoint 
 
A “re-operation” is defined as any surgical procedure of the affected study hip in which NO THA 
components are removed.  These subjects are not to be withdrawn.  An AE eCRF must be 
completed (e.g., reoperation could occur to treat an infection).  
 
All removed components are subject to further evaluation. If the implant is known to be available, the 
Sponsor will encourage the Investigator to preserve the prosthesis alone.  In the event of a death, the 
excised hip joint with the implant in place should be provided to the Sponsor if possible. Please contact 
the Sponsor for details should a retrieved study implant become available.  
15 INFORMED PATIENT CONSENT (IPC) PROCESS 
In compliance with ISO 14155 and 21CFR50, no Subject shall be enrolled in an investigation without 
provision of adequate informed consent.  The Principal Investigator is responsible for ensuring that no 
Subject is included in the study without adequate informed consent being provided.  Failure to obtain 
and properly document this process is in violation of ISO 14155, the Declaration of Helsinki, and this 
study protocol.   

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All Informed Patient Consent (IPC) documents must have favorable opinion of the IRB/REB/EC. Many 
institutions request modification of the IPC to satisfy specific institutional requirements.  The use of a 
modified or unique IPC is permitted provided that all the requirements of ISO 14155 are met and the 
document is approved before use by the Sponsor.   
Subjects who agree to participate in the study will complete an IRB/REB/EC approved IPC document 
that documents his or her willingness to take part in this study.  Each potential Subject will have the 
nature and the purpose of this study explained to him or her by the Principal Investigator (PI) or another 
delegated member of the investigative team at the study Site.  The PI or designee will explain the 
following features of the study to the patient thoroughly and will offer to answer any questions the 
patient may have.  
x The purpose of the study  
x The potential risks or adverse events that are posed by their treatment 
x The potential risks or adverse events related to study participation 
x Possibility of failure and the need for subsequent treatment(s) 
x Alternative procedures/treatments available to the Subject 
x Requirements of the study follow-up visits 
x All the Subject’s rights as a participant in the clinical investigation 
x The plan to perform retrieval analysis in the event of an explanted device 
x A modest payment may be provided to cover Subject travel expenditures associated with study 
participation up to 2 years postoperatively  
x Voluntary participation in the Patient Activity Tracking portion of the study, and the details 
associated with this portion of the study. 
Consent must be given by the Subject, or by a Legally Authorized Representative as applicable, and 
documented on an Informed Patient Consent Document in the primary language of the Subject.  A copy 
of the IPC is to be provided to the Subject. An IPC must be obtained for all Subjects prior to the Subject 
completing any study-specific assessments or procedures that are not standard of care.  A study Subject 
is considered enrolled in the study once they have signed the IPC.  
 

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Obtaining Consent Day of Surgery:  If the IPC document signatures are acquired on the day of 
surgery a time stamp on the signature page is required to support consent was obtained from the study 
Subject prior to any treatment related and/or mood-altering medications being administered. 
No dates should be pre-populated, or completed by someone other than the person providing the 
signature.   
 
Subjects will be made aware that their personal data will be collected and processed in accordance with 
data protection legislation including Health Insurance Portability and Accountability Act of 1996 
(HIPAA - refer to Section 5, Table 3, Definition of Terms). The release of Personal Health 
Information (PHI) for the purpose of this clinical investigation will be included in the informed patient 
consent. Results from this clinical investigation may be published, however, subject confidentiality 
will be maintained at all times and it will not be possible to identify them from any data presented.  
16 STATISTICAL METHODOLOGY 
Statistical analysis will be performed using SAS (SAS Institute Inc., SAS Campus Drive, Cary, North 
Carolina 27513) software version 9.3 or higher.  Any further software that may be necessary will be 
described in the final study report.  
16.1 
Study Design 
 The study design is a prospective, uncontrolled, non-randomized, multicenter study.  
A minimum of 255 Subjects that includes a minimum cohort of 225 Primary THA and a cohort of a 
minimum of 30 hemi-hip arthroplasty Subjects, will be prospectively enrolled into the study.  All 
Subjects will be seen for a preoperative clinic visit at the time of consent, and evaluated at the time of 
surgery, 6 weeks, 3 months, minimum 1 year, and minimum 2 years postoperatively.  
16.2 
Treatment Assignment 
The Actis® Total Hip System, specifically the medial collared DUOFIX® hip stem, is the only device 
of interest in the study; there will be no control group. Two cohorts of Subjects will be enrolled:  
x Subjects who receive a primary THA 
x Subjects who undergo a primary hemi-hip arthroplasty.  
16.3 
Levels of Significance 
There are no pre-specified hypotheses, and all analyses are exploratory.  Confidence intervals and p-
values may be provided to facilitate clinical judgement.  Unless otherwise stated, p-values will be 2-
sided and confidence intervals will be 2-sided 95% confidence intervals with no adjustments for 
multiplicity. 

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16.4 
Interval Windows 
See Section 6 Subject Management Study Schedule above.  
16.5 
Handling of Missing Data 
. Only actual subject data which is collected will be utilized in analyses.  
16.6 
Primary and Secondary Endpoints 
See Sections 10.2 and 10.3 
16.7 
Hypotheses 
This is not a hypothesis driven study. 
16.8 
Analysis Sets 
x This study will have 3 analysis sets which will be determined for both THA and hemi-hip 
Subjects as defined below and illustrated in the Data Flow Diagram: Enrolled Set is defined as 
all cases consented to participate in this study. The Enrolled Set will be used for the summary 
of disposition. 
x Safety Set is defined as all cases that received the Actis® Total Hip System. The Safety Set will 
be used to summarize demographic characteristics, adverse events and survivorship; 
x Per Protocol Set is defined as all Safety Set subjects without major protocol violations. The Per 
Protocol Set will be used for the summary of primary, secondary and tertiary endpoints. 
 
 

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Figure 16-1:  Analysis Set Flowchart 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
16.9 
 
Sample Size Justification  
The primary endpoint in this study is the Harris Hip Score at minimum 2-year postoperative. It is 
anticipated that this primary outcome measurement will be obtained on approximately 200 primary 
THA Subjects due to anticipated attrition. The standard deviation in this outcome will be approximately 
10 points (based on historical hip studies). It is therefore anticipated that the margin of error on the 
mean Harris Hip Score estimate at minimum 2-years postoperatively will be approximately 1.4 points. 
The study team believes this margin of error is sufficient for this 2-year outcomes and follow-up study. 
A sample size of N=30 hemi-hip arthroplasty procedures was established as a feasible number.   
16.10 
Analysis Plan  
Results for the cohorts of Subjects who were enrolled with a primary THA, and who were enrolled 
with a primary hemi-hip arthroplasty procedure will be summarized side-by-side, and overall, unless 
otherwise stated.   Demographics, baseline subject characteristics, procedure characteristics and the 
primary and secondary endpoints will be presented overall (pooled) and by study site. Descriptive 
statistics for dichotomous/categorical variables will include the number and percentage of subjects. For 
categorical endpoints, 2-sided 95% confidence intervals around observed percentages will be based on 
the binomial exact method. Descriptive statistics for continuous variables will include the number of 
subjects, mean, standard deviation, median, minimum, and maximum. For continuous endpoints, 2-
sided 95% confidence intervals around the mean will be computed using the t-distribution.  
Primary THA, Per Protocol Population 
{Primary, Secondary and Tertiary Analyses not mentioned above} 
All cases from the Safety Population that did not have any major protocol violations 
N=? 
Consented/Enrolled Population 
{Adverse Event Narrative of cases that drop out of Safety Population} 
All cases consented to participate in this study         
N=? 
Safety Population 
{Demographic, Survivorship (THA only) and Adverse Event Analysis} 
All cases that received the Actis™ Total Hip System  
N=? 
Did not receive the Actis® Total Hip System 
(including cases that did not have surgery) N=? 
Primary THA:  <enter subject numbers> 
Primary Hemi-hip: <enter subject numbers> 
Minus 
Minus 
Inclusion/Exclusion Violations N=?  
Primary THA: <enter subject numbers> 
Primary Hemi-hip: <enter subject numbers> 

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16.11 
Primary Endpoint 
The primary endpoint is the total Harris Hip Score at minimum 2 years after cementless primary total 
hip arthroplasty (THA) or hemi-hip arthroplasty.  This primary endpoint analysis will be conducted on 
both groups combined (primary THA and primary hemi-hip arthroplasty); however, results will also 
be analyzed separately for each cohort.   Descriptive statistics that include the number, per group, of 
study hips, mean, standard deviation, median, minimum, and maximum will be presented. A 2-sided 
95% confidence interval around the mean will be computed using the t-distribution. 
16.12 
Secondary Endpoints  
x Harris Hip score at 3 months and 1 year. The same methods as described for the primary 
endpoint will be utilized for this secondary endpoint.  
x Radiographic evaluation at 2 years post-operatively. Radiographs will be read by an 
independent radiographic reviewer (IRR) at 6 weeks to act as a baseline measurement to be 
compared to radiographs taken at later time points (3 months, 1 year, and 2 years). Parameters 
measured include stem subsidence, shell migration, shell inclination angle, osteolytic lesions, 
radiolucencies, heterotopic ossification, demarcation lines (sclerotic lines), porous coating 
integrity (delamination/bead shedding), calcar remodeling, femoral stem tilt (appearance), and 
leg length discrepancy. Please refer to the Radiographic Parameters Appendix D for details on 
how these measurements are taken. For analysis purposes, minimum change from baseline 
thresholds are defined below for several of these parameters; These threshold levels are 
considered to be clinically important change from baseline thresholds: 
o Femoral stem Subsidence – greater than 2 mm 
o Acetabular shell Migration – greater than 2 mm 
o Acetabular shell Inclination angle – change greater than 4 degrees 
o Osteolysis – greater than 5 mm in the greatest dimension 
o Radiolucencies – greater than 2 mm in width 
The percentage of cases that exceed the thresholds provided above will be presented by visit 
for each radiographic parameter, along with the number of cases and 2-sided 95% confidence 
intervals based on the binomial exact method. A listing of the cases exceeding the thresholds 
will also be provided along with the corresponding numerical measurement (i.e. radiolucency 
width measured in mm). Further, the number and percentage of the other radiographic 
parameters will be presented along with a listing of cases with undesirable results (i.e. cases 
with Heterotopic Ossification not equal to ‘None’). 
x Leg length discrepancy (LLD) will be analyzed by study visit in several ways:  

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o Analysis of “True” versus “Perceived” LLD: Each subject will be asked, yes or no, if they 
Perceive that they have LLD both before and after undergoing hip replacement.  Percentages 
will be presented along with 95% binomial exact confidence intervals.  
o Radiographic measurements will provide True LLD by measuring each leg to the nearest 
millimeter. A LLD of 3 cm or greater will be considered a true LLD. A McNemar’s test of 
discordant pairs will be utilized to compare perceived vs. actual LLD before surgery, and 
also to compare perceived vs. actual LLD after surgery.  
o Analysis of Change (post-surgical – pre- surgical) of True LLD: Compare the difference 
between the absolute true LLD before and after hip replacement surgery for those cases that 
had a true LLD prior to hip replacement surgery (using a definition of 3 cm or greater as 
the threshold). The analysis variable will be the absolute value of the difference between 
the right and left knee and a paired t-test will be used to assess this difference. 
o Analysis of proportion of cases that have true LLD after surgery will be presented and this 
will be compared to the proportion that had true LLD prior to surgery; McNemar’s test of 
discordant pairs will be conducted. 
x The type and frequency of AEs through 2 years post-operatively will be presented in table form 
and via a listing. Frequencies and listing of AE’s seriousness, severity, whether unanticipated, 
outcome, and treatment will also be presented. 
x Device survivorship at 2 years post-operatively. Kaplan-Meier survivorship will be conducted with 
removal of any component, defined as revision, for any reason specifying the event of interest. 
Cases not revised will be censored at their date of last follow-up, death, or withdrawal from the 
study. Survivorship point estimates and 95% confidence intervals will be presented when 40 
subjects are left being followed.  Survivorship analysis is not planned for the cohort of hemi-hip 
subjects as the sample size is insufficient; however, a listing will be provided to present all subjects 
requiring removal of any component. 
x Stem Revision at 2 years post-operatively. 
x Kaplan-Meier survivorship will be conducted with removal specifically of the femoral stem 
component, defined as revision, for any reason specifying the event of interest. Cases not revised 
will be censored at their date of last follow-up, death, or withdrawal from the study. Survivorship 
point estimates and 95% confidence intervals will be presented when 40 subjects are left being 
followed.  Survivorship analysis is not planned for the cohort of hemi-hip Subjects as the sample 
size is insufficient; however, a listing will be provided to present all Subjects requiring removal of 
the femoral stem component. 

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16.13 
Tertiary Endpoints 
x Change in Subject Outcomes (i.e., FJS-12, HOOS and Hip Evaluation) will be measured and    
compared from preoperative to 6 weeks, 3 months, minimum 1 year and minimum 2 years. 
o Raw measurements and change from baseline (pre-op) scores will be presented for FJS-12 
and HOOS scores and will include number of subjects, mean, standard deviation, median, 
minimum, and maximum. Two-sided 95% confidence intervals around the mean will be 
computed using the t-distribution. 
o Frequency tables will be provided for the following Hip Evaluation outcomes and include 
2-sided 95% confidence intervals based on the binomial exact method: satisfaction, 
procedure again, and groin and buttock pain.  
x Voluntarily participating study Subjects utilizing the wearable Patient Activity Tracking device and 
will provide the Sponsor with data on daily activity (e.g., pain, location of pain, mood/emotion, 
activities of daily living and range of motion, and after surgery Subject satisfaction will be asked 
periodically) from the time of consent preoperatively (if possible) through 3 months postoperative. 
o The number of subjects participating, and the completeness and cleanliness of those data 
will impact analysis methods. At minimum, pain level before and after surgery will be 
summarized and presented by the corresponding category. Pain, location of pain, 
mood/emotion, activities of daily living, range of motion and Subject satisfaction will also 
be summarized.  
16.14 
Interim Analysis  
Ad hoc interim analyses may occur as required for either THA or the hemi-hip arthroplasty populations. 
There are no planned interim analyses for the purpose of stopping the study early. 
17 DATA MANAGEMENT  
17.1 
Data Management for Subject Operative Details and Follow-up Evaluations   
Electronic Case Report Forms (eCRFs) entered into an electronic data (EDC) system will be used to 
collect all Subject data once a Subject is enrolled in the study. Study sites will be asked to enter Subject 
data into the eCRFs via the EDC web based database portal promptly after each study visit. 
 
The patient-reported outcome measures (i.e., FJS-12, HOOS and Hip Evaluation) will be recorded on 
paper-based questionnaires. The data will then be entered into the respective eCRF within the EDC 
system by the PI or designee.  The patient-reported outcomes measures captured on paper-based 
questionnaires must be stored in the Subject’s medical notes, as these are the source document. Any 
errors on paper-based questionnaires should be crossed out with a single stroke, initialed and dated by 
the Subject; a study site must not alter any data entered on the paper-based questionnaires.  Typing 
correction fluid must not be used. The PI will retain one copy of each completed paper-based 

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questionnaires (e.g., HOOS) in the medical notes and another copy will be kept in the site study file 
(e.g., individual study Subject binder or Subject specific tab if contained within a single binder).  
 
For all Subjects, detailed information related to the primary diagnosis, anesthesia type and time, if a 
specific kind of fracture table (e.g., HANA Table) was utilized, and surgical exposure (e.g., anterior 
approach), and other surgical variables will be recorded on the Operative Details eCRF. Any 
occurrence of an operative complication must be recorded on the AE eCRF. An intra-operative device 
or procedure related complication is defined as a complication that occurs from the start of anesthesia 
to when the Subject returns to their room. Please complete a separate AE eCRF for each intra-operative 
complication. Labels for each device or component used during the procedure must be recorded on 
Device Log eCRF.  
 
Data collected during the study for each Subject will be maintained as accurately and completely as 
possible with entries into an EDC system provided by DePuy Synthes.  The personal data recorded on 
all documents, including copy documents, and within the system will be regarded as confidential. The 
PI will be responsible for the timing, completeness and accuracy of the details entered within the EDC 
system.  All data entered in the database must have source documents in the Subject’s medical records. 
 
The Investigator should retain copies of all documents pertaining to this study (including source 
documentation, the informed consent document and any other documents to identify the Subjects) for 
at least two years after this clinical investigation is completed.  In addition, if the PI moves/retires, etc., 
she/he should provide DePuy Synthes with the name and address of the person who will look after and 
be responsible for the Subjects’ study related records. 
18 CLINICAL MONITORING 
Actis® is a minimal risk study not regulated by 21 CFR Part 812, and due to the level of risk, onsite 
interim monitoring is not required; however, to further increase confidence in the quality of this post-
market study data, targeted monitoring activities at clinical sites may be conducted. If on-site 
monitoring activities are determined necessary, they will be conducted as outlined in a study specific 
Monitoring Plan.  
19 STUDY DEVICES  
The Actis® Total Hip System (Actis®) is indicted for cementless use for primary total hip arthroplasty 
(THA) and hemi-hip arthroplasty.   
 
A total hip prosthesis is composed of individually packaged titanium (Ti-6A1-4V) femoral hip stem, 
modular metal or ceramic femoral head, and a two-piece metal-backed Ultra High Molecular Weight 

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Polyethylene (UHMWPE), acetabular components designed to replace the natural articular surface of 
the hip joint.  
 
Hemi-hip prosthesis is comprised of a titanium (Ti-6A1-4V) femoral stem and a metal head designed 
to replace the natural femoral head and neck in hemi-arthroplasty.  
 
The Actis® medial collared DUOFIX® hip stem is manufactured from forged titanium alloy (Ti-6A1-
4V) and has a sintered commercially pure titanium bead porous coating (POROCOAT®), and a thin 
layer of plasma-sprayed hydroxyapatite (HA) coating.  Refer to Appendix E for a complete listing of 
the Actis® Total Hip System and compatible component product codes.  
 
Only the compatible acetabular cups, acetabular liners and femoral heads listed in Appendix E are 
allowed for use in this clinical investigation. 
20 DEVIATIONS & NON-COMPLIANCE HANDLING  
With the exception of emergency situations, no deviations to this clinical investigational plan will be 
permitted.  In the event of an emergency situation the Principal Investigator must notify the Sponsor 
immediately.  A full written report of the situation must be forwarded to the IRB/REB/EC Committee 
who approved the original CIP and DePuy Synthes promptly.  
20.1 
Lost to Follow-up 
There may be study Subjects who will not or cannot return for follow-up examinations as prescribed 
in this clinical investigation. These individuals will not be considered as “lost to follow-up”, but as 
non-compliant with the study protocol and thus entered into a missing data category. This group 
includes: 
x Subjects who refuse to return for follow-up 
x Subjects who relocate without notifying the Sponsor, or the Principal Investigator, and cannot 
be located for continued follow-up arrangements 
Subjects that are considered “lost to follow-up” cannot be considered withdrawn from the study.  The 
PI must continue efforts to schedule the Subject until study closure or the Subject provides 
communication (preferably written) of a desire to withdraw from study participation. Both oral 
(telephone) and written (email or letter) correspondence should be employed to schedule the Subject. 
If a Subject does not respond, a registered letter should be sent to the Subject indicating the importance 
of the follow-up visits and to contact the office immediately. Each PI will maintain a record of 
communications and/or attempts at communications in the source documentation.  

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21 ETHICAL PRINCIPLES 
This clinical investigation shall be conducted in accordance with the ethical principles that have their 
origin in the Declaration of Helsinki. The Declaration of Helsinki and other guiding principles are also 
noted above in the protocol signature page.   
22 PRINCIPAL INVESTIGATOR RESPONSIBILITIES  
An Investigator’s responsibilities in conducting clinical investigations of a medical device are 
described below. Additionally, a signed agreement between the Investigator and Sponsor will be in 
place prior to consent of the first subject into the study.  
 
In conducting this medical device clinical investigation, the Investigator is responsible for:  
1. 
Ensuring that a clinical investigation is conducted according to applicable regulations, the 
signed Investigator agreement, and the investigational plan;   
2. 
Protecting the rights, safety, and welfare of subjects under the Investigator’s care.  
22.1 
Institutional Review Board Approval (IRB or REB or EC)  
Each Investigator must obtain IRB/REB/EC approval prior to the consent of the first Subject; no study-
related procedures can occur without the approval and oversight of a registered IRB/REB/EC.  
All Principal Investigators must submit for initial review a copy of the clinical investigational plan 
(CIP) and a sample Informed Patient Consent Document (IPC) to their institution’s IRB/REB/EC. 
Initial approval must be documented; originals of correspondence and approvals are to be filed by the 
Investigator and copies forwarded to the Sponsor.  
Continuing review and any other additional required submissions will be forwarded for IRB/REB/EC 
review according to their policies and procedures. Approval or acknowledgement must be documented; 
originals of correspondence and approvals are to be filed by the Investigator and copies forwarded to 
the Sponsor. 
22.2 
Informed Patient Consent (IPC)  
The Principal Investigator is responsible for ensuring that no Subject is included in the study without 
adequate informed consent being provided. Source documents must be maintained, evidencing 
informed consent was obtained prior to participation in the study. Failure to obtain or properly 
document this process is in violation of ISO 14155, 21CFR50, the Declaration of Helsinki and this 
study protocol. 

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See descriptions of the Informed Consent process in Section 15 and a sample Informed Patient Consent 
Document in Appendix B. Each subject is entitled to withdraw from this clinical investigation for any 
reason without obligation and/or prejudice to further treatment.  
The Investigator will clearly document the date and reason(s) for the subject’s withdrawal from this 
clinical investigation, and submit the appropriate eCRFs to DePuy Synthes.  
22.3 
Source Documentation 
The Investigator will maintain source documentation records of each Subject’s case history.  Case 
histories include the case report forms and medical records, including progress notes, hospital charts, 
nurses’ notes, etc. 
Records shall include: 
x Documents evidencing informed consent 
x All relevant observation concerning adverse events 
x Subject history of each Subject upon entering the study 
x Information on the condition of the Subject during the course of the study. 
22.4 
Electronic Case Report Form (eCRF) Completion 
Electronic Case Report Forms (eCRFs) in an electronic data collection (EDC) system will be used to 
collect all Subject data once a Subject is enrolled in the study. Investigative study sites will be asked 
as a best practice to enter Subject data into the eCRFs no later than 2 to 4 weeks from the time the 
Subject was seen for their scheduled study visit. 
 
Detailed description of the eCRF components and eCRF completion guidelines are included in the User 
Instructions available in the MediData Rave System and eCRF Completion Instructions (CCIs), which 
will be provided to the Investigators and applicable site staff to aid in data entry in the EDC system. 
The respective eCRFs must be fully completed for each Subject and signed electronically by the 
Investigator.  
 
The patient reported outcome measures (i.e., FJS-12, HOOS and the Hip Evaluation) will be recorded 
on paper questionnaires (i.e., source documentation). The data will then be entered into the respective 
eCRF within the EDC system by the PI or a properly delegated designee. The patient reported outcomes 
measures captured on paper-based questionnaires must be stored in the Subject’s medical notes, as 
these will be considered to be the source document. Any errors on paper-based forms should be crossed 
out with a single stroke, initialed and dated. Typing correction fluid must not be used.  

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22.5 
Clinical Investigation Plan (CIP) Adherence  
The Investigator must not deviate from the investigational plan without first receiving approval from 
the Sponsor and reviewing IRB/REB/EC, except when necessary to eliminate apparent immediate 
hazards to a subject. 
Except for emergency situations, no deviations to this CIP will be permitted; please refer to Section 20 
for further details regarding protocol deviations and non-compliances.  
The Investigator will notify the Sponsor and the reviewing IRB/REB/EC of any deviation from the 
investigational plan.    
22.6 
Clinical Investigation Plan (CIP) Amendments 
Applicable IRB/REB/EC approvals will be obtained prior to implementation of changes in the Clinical 
Investigational Plan that may affect the scientific soundness of the investigation or the rights, safety or 
welfare of study subjects.  Administrative changes must also be submitted to the reviewing 
IRB/REB/EC.  
22.7 
Investigator Reporting Responsibilities 
The Principal Investigator is responsible for submitting complete, accurate and timely reports as 
described below in Table 10.  
22.8 
Table 10 Principal Investigator Reporting Responsibilities 
                         Table 10 Principal Investigator Reporting Responsibilities 
Report 
Description 
Withdrawal of IRB/REB/EC Approval 
The Investigator will notify the Sponsor of a 
withdrawal of approval by the reviewing 
IRB/REB/EC of the Investigator’s part in an 
investigation within 5 working days. 
Reports of Deviations from the Clinical 
Investigational Plan (CIP) 
Investigator will promptly report deviations from 
the CIP to the Sponsor via the EDC system, and to 
the reviewing IRB/REB/EC (as applicable per the 
requirements). 
Other 
The Investigator will, upon request by a reviewing 
IRB/REB/EC, provide accurate, complete, and 
current information about any aspect of the 
investigation. 

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Serious Adverse Event  
(SAE defined in Section 13) 
The Investigator will notify the Sponsor, and their 
reviewing IRB/REB/EC’s as applicable, of all 
SAEs upon receiving notice or discovery of the 
event.   
Unexpected/Unanticipated Adverse 
Device Effect (UADE defined in 
Section 13) 
All potential UADEs that occur during this 
investigation must be reported by the Investigator no 
later than 72 hours from the time when the 
Investigator is aware of the event to the Sponsor by 
telephone 
(800) 
829-7003, 
electronic 
correspondence, or facsimile (574) 371-4950.  
 
In the event of a UADE or serious adverse device 
effect, the Investigator should institute appropriate 
therapeutic and follow-up measures in accordance 
with good medical practice and notify the local 
IRB/REB/EC.  The Investigator must document 
follow-up treatment in the “comment” section of the 
AE eCRF.  A full written report of the event must be 
forwarded to DePuy Synthes within 10 working days 
of the discovery. 
22.9 
Investigator Site Files (ISF or Regulatory Binder) 
Each Investigator must maintain accurate, complete, and current information about all aspects of this 
clinical investigation. This includes documentation relating to the Investigator’s participation, and all 
correspondence relating to the clinical investigation. Correspondence consists of, but is not limited to, 
written and verbal correspondence with other participating Investigators, the reviewing IRB/REB/EC, 
and the Sponsor.  
23 SPONSOR OBLIGATIONS  
23.1 
Ethics (IRB/REB/EC) Approval 
Each Investigator must obtain Institutional Review Board (IRB)/Research Ethics Board (REB)/Ethics 
Committee (EC) approval prior to consent of the first Subject. Each Investigator must also maintain 
continuous approval. Documentation of initial approval, subsequent renewals and IRB closure must be 
provided to the Sponsor, and filed on site in the Investigator Site File (ISF). Additionally, amendments 
to the protocol will be submitted for review before implementation, and copies of the submissions and 
approvals provided to the Sponsor.   
 
The Sponsor will maintain copies of all site IRB/REB/EC documentation in the Trial Master File. 

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23.2 
Investigator Training 
Prior to enrolling Subjects in this study, the Investigator and/or appropriate Site personnel will be 
trained in general aspects of study administration, content and manner of administration of the Subject 
questionnaires, all procedures in the protocol, and the procedure for e-data acquisition and radiographic 
transmission.    
 
Training will be done through a combination of teleconferences, Web-Ex conferences and on-site 
training as appropriate.  Site visits, if required, will be arranged once IRB/REB/EC approval is obtained 
and the Clinical Research Agreement is executed.   
23.3 
Sponsor Reporting Responsibilities 
This is not a regulated study and reporting to regulatory agencies is not required.  
The Sponsor will provide regular reports directly to the study Site in order to communicate study 
progress and Site study conduct periodically throughout the study. In general, these reports are provided 
quarterly; however, this frequency may be modified based upon enrollment rate and phase of project. 
Additional reports the Sponsor is responsible for preparing and submitting are as described below in 
Table 11.  
Table 11 Sponsor Reporting Responsibilities 
Report 
Description 
Withdrawal of IRB/REB/EC Approval 
The Sponsor shall notify all reviewing 
IRB/REB/ECs and participating Investigators of 
any withdrawal of approval of the investigation by 
a reviewing IRB/REB/EC within 5 working days 
after receipt of notice. 
Unanticipated Adverse Device Effect 
(UADE)  
The Sponsor must notify FDA, all reviewing 
IRB/REB/EC’s and all participating Clinical 
Investigators of all UADEs within 10 working days 
of first receiving notice of the event.  In addition, 
the event will be reported to the DePuy Synthes 
Complaint Handling Unit for investigation. 
Other 
The Sponsor will, upon request by a reviewing 
IRB/REB/EC provide accurate, complete, and 
current information about any aspect of the 
investigation. 

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23.4 
  Insurance 
The Sponsor recognizes its liability in law to compensate for any injury sustained by a Subject 
participating in this clinical investigation because of negligence or breach of duty of care; adequate 
insurance provisions have been made by DePuy Synthes to compensate any Subject so injured.   
23.5 
Financial Agreement 
Funding of this clinical investigation will be the subject of a separate agreement between the Sponsor 
and the Institution where the clinical investigation is being conducted and the Principal Investigator 
(where permitted by the Institution). 
23.6 
Sponsor Study Termination 
The Sponsor may prematurely terminate or suspend the clinical study as a whole or at an individual 
investigational site for significant and documented reasons.  Reasons for premature termination or 
suspension include, but are not limited to safety, inadequate recruitment, Principal Investigator issues, 
and device related problems, alignment with business strategy or administrative issues.  
 
If suspicion of an unacceptable risk to Subjects arises during the clinical study, or when instructed by 
an IRB/REB/EC or a Regulatory Authority, the Sponsor shall suspend the clinical study at all active 
sites while the risk is assessed. The Sponsor shall terminate the clinical study if an unacceptable risk is 
confirmed, or resume the clinical study following appropriate communication and approval from the 
IRB/REB/EC and a Regulatory Authority as required. 
 
In terminating the clinical study, the Sponsor and the Principal Investigator will assure that adequate 
consideration is given to the protection of the subject’s interests. All documentation is archived and the 
appropriate bodies such as the IRB/REB/ECs and any Regulatory Authorities are informed as 
appropriate.  
24 PUBLICATION PLAN  
All manuscripts of data obtained from this clinical investigation will be reviewed and approved by the 
Sponsor, and each author, prior to any submission. And, current and applicable Medical Device & 
Diagnostic (MD&D) Publication Policy will be followed.    
 
DePuy Synthes will require a written agreement for any external author(s) prior to initiating any 
publication. All authors must disclose financial or personal affiliations that could be considered a 
conflict of interest. 

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25 STUDY SUMMARY STATEMENT 
In summary, this study will provide 2-year safety and performance data and outcomes for the Actis® 
Total Hip System. For a given Subject, their study participation will end when they have reached the 
final endpoint; that is, each Subject will reach “end of study” when they have had the minimum 2-year 
clinical evaluation. For Subjects participating in the optional and parallel Patient Activity Tracking 
portion of the study (ActiTrak™), their participation in that particular aspect of the study will be 
completed when they have 3-months of postoperative data collected.