Alloclassic® Variall® Cup Ceramic Bearing System in Total Hip Arthroplasty A Multi-center, Prospective, Non-controlled Post Market Surveillance Study
Conditions: Avascular Necrosis, Osteoarthritis, Inflammatory Arthritis, Posttraumatic Arthritis
Sponsor: Zimmer Biomet

Alloclassic® Variall® Ceramic Bearing System 
 
2020-10-19 - Rev. 1 
Protocol # CME2014-03H 
 
Page 1 of 3 
 
 
 
Alloclassic® Variall® Cup Ceramic Bearing System in Total Hip 
Arthroplasty 
 
A multi-center, prospective, non-controlled post market surveillance study  
 
 
PROTOCOL NO. CME2014-03H 
 
 
NCT NUMBER: NCT03672370 
 
 
 
PROTOCOL VERSION: 
2014-09 - REV. 01 
 
 
 
 
 
 
 
 
STUDY SPONSOR 
 
ZIMMER GMBH 
ZÄHLERWEG 4 
CH-6300 ZUG 
SWITZERLAND 
 
 
 
 
 
 
 
 

Alloclassic® Variall® Ceramic Bearing System 
 
2020-10-19 - Rev. 1 
Protocol # CME2014-03H 
 
Page 2 of 3 
 
Title: 
Alloclassic® Variall® Ceramic Bearing System in Total Hip Arthroplasty 
A multicenter, prospective, non-controlled post market surveillance study 
Sponsor: 
Zimmer GmbH 
Objectives: 
The objectives of this study are to obtain survival and outcomes data on 
the Alloclassic® Variall® Cup 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, function and survivorship, and 
to confirm the safety and performance of the Alloclassic® Variall® Cup 
Evaluation of squeaking and ceramic fracture rate will be an additional 
objective.  
Safety will be evaluated by monitoring the frequency and incidence of 
adverse events. 
Performance will be based on the implant survival, the overall pain and 
functional performances, subject quality-of-life and radiographic 
parameters of study subjects who received the Alloclassic® Variall® Cup. 
Pain and functional performance will be measured using the Harris Hip 
Score, survivorship will be based on removal or intended removal of the 
device. Subject quality-of-life will be determined by evaluation of the EQ-
5D and the Oxford Hip Score, and radiographic parameters by analysis of 
x-rays. 
Indication/ 
Target Population: 
Patients, suffering from severe hip pain and disability requiring total hip 
arthroplasty, who meet the inclusion/ exclusion criteria. 
Study Design: 
Multicenter, prospective, non-controlled 
Clinical Phase: 
Post-market 
Number of Subjects: 
A total of 100 patients will be enrolled in this study 
Length of Study: 
12 years (2 year enrollment plus 10 years follow-up): follow-up visits at 3 
months, 1, 2, 3, 5, 7, and 10 years post-operatively. 
Study Device: 
Alloclassic® Variall® Cup in combination with: 
Ceramic-on-Ceramic Articulation:  
BIOLOX® delta Taper Liner and 
 
 
 
 
 
BIOLOX® delta Femoral Head  
Femoral Component:  
 
 
Avenir® uncemented Stem or
 
 
 
 
 
Alloclassic® Variall® Stem 
Comparator Device/  
Procedure: 
None 
Clinical Assessments: 
Evaluations will be made using the Harris Hip Score, Oxford Hip Score, 
EQ-5D and radiographic evaluation.  
Safety Assessments: 
Safety will be assessed by appropriate recording and reporting of adverse 
events throughout the study. All system components are CE marked and 
commercially available 
Statistical analysis: 
Data collected will be summarized and reported to each participating 
Investigator. Statistical analysis is conducted by Zimmer or its designee. 
 

Alloclassic® Variall® Ceramic Bearing System 
 
2020-10-19 - Rev. 1 
Protocol # CME2014-03H 
 
Page 3 of 3 
 
General Statistical Method: 
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. 
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 EQ-5D, Oxford 
Hip Score, concomitant medication usage, and incidence of adverse events.