Arcos Revision Stem: Evaluation of Clinical Performance
Conditions: Osteoarthritis, Avascular Necrosis, Rheumatoid Arthritis, Deformity, Fracture, Complications; Arthroplasty
Sponsor: Zimmer Biomet

Arcos Study 
Protocol number: GBMET.CR.US19.12 
 
 
 
Arcos® Revision Stem: Evaluation of 
Clinical Performance 
 
A Retrospective and Prospective Multi-Center Two-Armed Non-Comparative Clinical 
Investigation on 200 subjects 
 
 
 
 
 
 
 
 
 
 
 
 
PROTOCOL Number (Study ID): GBMET.CR.US19.12 
PROTOCOL data and version: March 18, 2015, Version. 6 
NCT Number: 01820611 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Arcos Study 
Protocol number: GBMET.CR.US19.12 
1 STUDY SYNOPSIS 
 
TITLE 
Arcos Revision Stem: Evaluation of Clinical Performance 
CIP ID  
GBMET.CR.US19 
SPONSOR 
Original: Biomet 
Administratively transferred: Zimmer GmbH, Zählerweg 4, 
6300 Zug, Switzerland 
MANUFACTURER 
Biomet Orthopedics 
STUDY DEVICE (S) 
Arcos Modular Revision Femoral System 
OBJECTIVE/ENDPOINTS 
The primary purpose of this study is to evaluate the clinical 
performance of the Arcos Revision Stem system, 
determine the stability of the implants, and evaluate any 
relationship between bone defect level and the success of 
the Arcos Stem. 
Primary Endpoints: 
- 
Survivorship and revision rate up to 5 years 
Secondary Endpoints: 
- 
Stability and Fixation of Arcos Hip by radiographic 
assessment, Relationship between bone defect 
level, Oxford hip score and Harris hip score 
postoperative 
- 
Adverse events, complications 
POPULATION 
200 Patients: 100 with BoneMaster HA, 100 without 
BoneMaster HA 
Up to ten sites will be used to fulfill enrollment to this study 
 
All cases enrolled will be those implanted with either the 
Cone, Broached, or Calcar Proximal Body and one of the five 
distal options (Slotted, Bullet-tip, Interlocking, STS, or ETO). 
ELIGIBILITY 
To be included in the study, a patient have received a 
revision total hip arthroplasty with the Arcos system. The 
Arcos system is to be used in accordance to the indications 
for use and contraindications detailed in the approved 
labeling of the device. 
INCLUSION/EXCLUSION 
CRITERIA 
Inclusion Criteria 
Patients will be included in this study if they received the 
Arcos Modular Femoral Revision System per the approved 
indications for use for Arcos specifically. 
- 
Patients undergoing Revision of previously failed 
total hip arthroplasty. 

Arcos Study 
Protocol number: GBMET.CR.US19.12 
The Arcos™ Modular Femoral Revision System hip 
components are single-use implants, intended for 
uncemented use only. 
Only subjects who have received the Arcos Revision Stem 
System will be included in this outcomes study. 
 
Exclusion Criteria 
Absolute contraindications include: active infection, 
sepsis, and osteomyelitis. 
Relative contraindications include: 
- 
Uncooperative patient or patient with neurologic 
disorders who are incapable of following directions 
- 
Osteoporosis 
- 
Metabolic disorders which may impair bone 
formation 
- 
Osteomalacia 
- 
Distant foci of infections which may spread to the 
implant site 
- 
Rapid joint destruction, marked bone loss or bone 
resorption apparent on roentgenogram 
- 
Vascular insufficiency, muscular atrophy, or 
neuromuscular disease. 
Additionally, all vulnerable subjects (minors, limited or 
non-readers; adult subjects who cannot consent for 
themselves; and, pregnant women) will be excluded from 
participation in this study. 
STUDY DESIGN 
Retrospective and Prospective Multi-Center Two Armed 
Non-Comparative Trial 
CLINICAL PHASE 
Post-Market 
NUMBER OF SUBJECTS 
200 Patients  
- 
100 with BoneMaster HA 
- 
100 without BoneMaster HA 
LENGTH OF STUDY 
5 years (24 months enrolment and 5 years follow up) 
MATERIAL AND 
METHODS 
Case Report Forms will be completed at 6-12 months, 2-3 
years and 5 years post-operatively. 
 
 
 
 
2 STATISTICAL ANALYSIS PLAN 

Arcos Study 
Protocol number: GBMET.CR.US19.12 
DATA REPORTING 
The sponsor will present an annual report to the investigators that will include a summary of the 
clinical data. The report will contain the results of the Harris Hip at each time point. Also, patient 
follow-up will be analyzed throughout the data collection according to the following definition 
and equations: 
Lost To Follow-Up: 1. Death 
2. Revision 
3. Consent Rescinded 
Percentage Follow-up = # Patients with Follow-Up______ x 100 
(Theoretically due – Lost To Follow-Up) 
Percentage Accounted for = (# with Follow-Up + Lost To Follow-Up) x 100 
Theoretically due 
At the end of the data collection, a final report will be compiled that will summarize all data 
collected throughout the data collection, complications throughout the course of the data 
collection, and general findings. 
 
SAMPLE SIZE JUSTIFICATION  
Observational study with 200 Arcos modular femoral revision cases (100 with Bonemaster and 
100 without Bonemaster) to assess survivorship and revision rate up to 5 years.  
The sample size for this study is based on anticipated sales (1000 during the first year of 
commercialization) and expected lost-to-follow-up over the first 5 years, with the goal of having 
a reasonable number of cases for evaluating device survival over the first 5 years of follow up.  
An article by Frederick Dorey, et.al. (Journal of Arthroplasty, 1(1):63-69, 1986) recommends 
having greater than 20 subjects in follow-up when estimating survivorship. Lost to follow-up for 
this study is estimated to be 10% per year. Thus, if 100 patients of the Arcos with Bonemaster HA 
and 100 cases of Arcos without Bonemaster are enrolled, there will be 59 patients at 5 years of 
follow-up for each variant. 
Start with 100 cases and assume a loss of 10% per year  
o 1 year: 100-10 = 90  

Arcos Study 
Protocol number: GBMET.CR.US19.12 
o 2 year: 90-9= 81  
o 3 year: 81-8=73  
o 4 year: 73-7= 66  
o 5 year: 66-7 = 59  
59 cases is a reasonable number for evaluating survivorship at 5 years per Dorey, et. al.