Allofit® IT Ceramic Bearing System in Total Hip Arthroplasty: A Multi-center, Prospective, Non-controlled Post Market Surveillance Study
Conditions: Avascular Necrosis of Hip, Osteoarthritis, Hip, Inflammatory Arthritis, Post-Traumatic Osteoarthritis of Hip
Sponsor: Zimmer Biomet

Allofit IT Ceramic Bearing System in THA 
Protocol number: CME2010-24H 
1 
 
 
 
 
 
 
 
 
 
Allofit® IT Ceramic Bearing System 
in Total Hip Arthroplasty 
A multi-center, prospective, non-controlled post market surveillance study 
 
 
 
 
 
 
Protocol number: CME2010-24H 
Protocol date: 15-Feb-2021, Rev 03 
NCT number: NCT03672916 

Allofit IT Ceramic Bearing System in THA 
Protocol number: CME2010-24H 
2 
 
 
1 
STUDY SYNOPSIS 
 
 
Complete Protocol Title 
Allofit IT Ceramic Bearing System in Total Hip Arthroplasty 
A multi-centre, prospective, non-controlled post market 
surveillance study 
Protocol Number 
CME2010-24H 
Short Protocol Title 
Allofit IT Ceramic Bearing System in THA 
Sponsor 
Zimmer GmbH 
Manufacturer 
Zimmer GmbH 
Study Device(s) 
Allofit IT Shell in combination with: 
• 
Ceramic-on-Ceramic Articulation: BIOLOX delta Ta- 
per Liner and BIOLOX delta Femoral Head 
• 
Femoral Component: Alloclassic® Zweymuller® Hip 
Stem, CLS® Spotorno® Stem or Fitmore® Stem 
Study Objectives/Endpoints 
The objectives of this study are to obtain survival and 
outcome data on the Allofit IT Shell in combination with 
the BIOLOX® delta Taper Liner when used in primary total 
hip arthroplasty. This will be done by analysis of standard 
scoring systems, radiographs and adverse event records. 
Data will be used to monitor pain, mobility, and 
survivorship, and to confirm the safety and efficacy of the 
Allofit IT Ceramic Bearing System. Evaluation of squeaking 
and ceramic fracture rate will be an additional objective, 
the latter by evaluating by Adverse Events. 
Safety will be evaluated by monitoring the frequency and 
incidence of adverse events. 
Performance will be determined by evaluating 
survivorship, pain and functional performances, subject 
quality-of-life and radiographic parameters. 
Survivorship will be based on removal or intended removal 
of the device Pain and functional performance will be 
measured using the Harris Hip Score, subject quality-of-life 
will be determined by evaluation of the EQ-5D and SF12, 
and radiographic parameters by analysis of x-rays. 
Indications/Target Population 
Patients, suffering from severe hip pain and disability 
requiring total hip arthroplasty, who meet the inclusion/ 
exclusion criteria. 
Inclusion/Exclusion Criteria 
Inclusion Criteria 
• 
Patient is 18 to 75 years of age, inclusive. 
• 
Patient is skeletally mature. 
• 
Patient qualifies for primary unilateral or bilateral 
total hip arthroplasty (THA) based on physical exam 
and medical history including the following: 
• 
Avascular necrosis (AVN) 

Allofit IT Ceramic Bearing System in THA 
Protocol number: CME2010-24H 
3 
 
 
 
• 
Osteoarthritis (OA) 
• 
Inflammatory arthritis (i.e. Rheumatoid arthritis) 
• 
Post-traumatic arthritis 
Patient has no history of previous prosthetic 
replacement device (any type, including surface 
replacement arthroplasty, endoprosthesis, etc.) of 
the affected hip joint(s). 
• 
Patient has a Harris Hip Score <70 in the affected 
hip 
• 
Patient is willing and able to provide written in- 
formed consent. 
• 
Patient is willing and able to cooperate in the re- 
quired post-operative therapy. 
• 
Patient is willing and able to complete scheduled 
follow-up evaluations as described in the Informed 
Consent. 
• 
Patient has participated in the Informed Consent 
process and has signed the Ethics Committee ap- 
proved informed consent. 
Exclusion Criteria 
• 
The patient is: 
• 
A prisoner 
• 
Mentally incompetent or unable to under- 
stand what participation in the study entails 
• 
A known alcohol or drug abuser 
• 
Anticipated to be non-compliant. 
• 
The patient has a neuromuscular disorder, vascular 
disorder or other conditions that could contribute 
to prosthesis instability, prosthesis fixation failure, 
or complications in postoperative care. 
• 
The patient has a vascular (large and small vessel 
disease) insufficiency. 
• 
The patient has a neurologic condition in the ipsilat- 
eral or contralateral limb which affects lower limb 
function. 
• 
The patient has a diagnosed systemic disease that 
could affect his/her safety or the study outcome. 
• 
The patient is known to be pregnant. 
• 
The patient is unwilling or unable to give informed 
consent, or to comply with the follow-up program. 
• 
The patient has received an investigational drug or 
device within the previous 6 months. 
• 
The patient has an active or latent infection in or 
about the affected hip joint or an infection distant 
from the hip joint that may spread to the hip hem- 
atogenously. 

Allofit IT Ceramic Bearing System in THA 
Protocol number: CME2010-24H 
4 
 
 
 
• 
The patient has insufficient bone stock to fix the 
component. Insufficient bone stock exists in the 
presence of metabolic bone disease (i.e. osteopo- 
rosis), cancer, and radiation. Note: Dual Energy X- 
ray Absorptiometry (DEXA) may be used to assess 
the presence of adequate bone stock. 
• 
The patient has osteoradionecrosis in the operative 
hip joint 
• 
The patient has a known sensitivity or allergic reac- 
tion to one or more of the implanted materials. 
• 
The patient has known local bone tumors in the op- 
erative hip. 
• 
The patient is Grade III obese with a Body Mass In- 
dex (BMI) > 40. 
Study Design 
Multicentre, Prospective, Non-controlled 
Clinical Phase 
Post-market 
Sample Size 
A total of 200 patients were planned 
185 patients were implanted with the study device and 
included in the study 
Length of Study 
12 years (2 years of enrollment (all sites) and 10 years of 
follow-up) 
Materials and Methods 
Case report forms will be completed at Pre-op, Surgery, 
Discharge, and the 6 month, 1-year, 2-year, 3-year, 5-year, 
7-year and 10-year intervals. 
Data Collection 
Paper/Electronic 
Statistical Reporting 
Data collected will be summarized and reported to each 
participating investigator. Statistical analysis will be 
conducted by Zimmer Biomet or its designee. Survivorship 
will be evaluated using Kaplan-Meier. 
Scores/Performance Assessments 
Harris Hip Score (HHS); UCLA activity score; SF12; EQ-5D- 
3L, Noise questionnaire 
Standards 
The PMCF is compliant with the below: 
• 
ISO 14155: 2020 - Clinical investigation of medical de- 
vices for human subjects - Good clinical practice. * 
• 
The Declaration of Helsinki (DoH) - Ethical principles 
for medical research involving human subjects. 
(*) The study protocol was drafted according to another version of the 
ISO 14155. Adverse Event definitions and reporting are according to ISO 
14155:2020. 
Study Funding 
Funding for this clinical study is made available by Zimmer 
Biomet to support clinical data collection, IRB/EC review 
fees and other expenses associated with the conduct and 
execution of this study protocol as outlined in the fully 
executed Clinical Trial Agreement. 

Allofit IT Ceramic Bearing System in THA 
Protocol number: CME2010-24H 
5 
 
 
2 
STATISTICAL ANALYSIS PLAN 
2.1 Analysis Objectives 
The assessment of efficacy for subjects receiving the total hip replacement system will be 
determined using the overall pain score and functional performance. Clinical success will be 
defined as a modified Harris Hip score of > 80 that included a rating of ‘mild’, or ‘no pain’; a 
failure will be defined as a modified Harris Hip score < 80. Any study hip that required a 
subsequent surgical intervention where a stem head, cup, or liner was removed, or where a 
removal was planned, was considered a failure regardless of the Harris Hip score. Success 
rates will be expressed as percentages and primary summary results will be presented in 
tables which will contain the number and percentage of patients classified as a clinical success 
for the treatment group. 
The assessment of safety will be evaluated by monitoring the frequency and incidence of 
adverse device effects in investigational subjects. As part of the safety profile, a survival 
analysis will be done. 
The endpoints that contributed to the composite success will be summarized separately, that 
is, the Harris Hip Score. Additionally, there are measures of interest which will be used to 
assess the investigational device such as radiographic success, all components included in 
the assessment of radiologic success, the SF-12 patient satisfaction scores, patient activity 
scores, concomitant medication usage, and incidence of adverse events. 
 
 
2.2 Sample Size Justification 
Sample size for the Allofit Ceramic PMCF Study was estimated using the McHugh and Le 
method [39] with an alpha (Type I) error level of 0.05, a non-inferiority margin of 5.2% (δ), and 
an assumed survival rate of 90% at 10 years from ODEP. 
The confidence limit approach, as discussed by McHugh and Le [39], can be used to calculate 
this sample size estimate. Specifically, we infer that the non-inferiority margin provides the 
absolute precision (5% δ) for the difference between the fixed rate in the historical control 
group and the rate estimated for the experimental group over the course of the study. Sample 
size estimation utilizes the following formula: 
 
 
= Z1− 
 
where δ represents the non-inferiority margin, n represents the group size, pexp represents the 
rate in the experimental group, pHC represents the rate in the historical control group, wexp 
n 
pexp (1− pexp ) 
+ pHC (1− pHC ) 
wexp 
wHC 

Allofit IT Ceramic Bearing System in THA 
Protocol number: CME2010-24H 
6 
 
 
represents a weight (i.e., allocation weight) to accommodate unequal group size for the 
experimental group, wHC represents the allocation weight to accommodate unequal group 
size for the historical control group, and Z1-α represents the value of a standard normally 
distributed random variable corresponding to a cumulative probability of one minus alpha 
(0.05). 
When adjusting for a ceiling in the calculation, and added attrition rate of 20% there is a sample 
size requirement of 195 for the experimental group. A sample size of 200 is therefore planned 
for enrolment in this study. 
Sample size was estimated using SAS v. 9.1.3 for Windows.