Randomized Controlled Study Comparing the Taperloc Complete Versus the Taperloc Complete Microplasty.
Phase: NA
Conditions: Hip Osteoarthritis, Noninflammatory Degenerative Joint Disease, Avascular Necrosis, Correction of Functional Deformity, Rheumatoid Arthritis
Sponsor: Zimmer Biomet

Taperloc Complete Microplasty 
 
2017-07 - Rev. 1.5 
Protocol # ORTHO.CR.GH60 
 
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RANDOMIZED CONTROLLED STUDY COMPARING THE TAPERLOC 
COMPLETE VERSUS THE TAPERLOC COMPLETE MICROPLASTY. 
 
 
PROTOCOL NUMBER: ORTHO.CR.GH60 
 
NCT NUMBER: NCT03409666 
 
 
 
 
PROTOCOL VERSION 
2017-07 – REV.1.5 
 
 
 
 
 
 
 
 
 
 
 
 
STUDY SPONSOR 
ZIMMER GMBH 
ZÄHLERWEG 4 
CH-6300 ZUG 
SWITZERLAND  
 

Taperloc Complete Microplasty 
 
2017-07 - Rev. 1.5 
Protocol # ORTHO.CR.GH60 
 
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Complete Protocol 
Title 
Randomized controlled study comparing the Taperloc Complete 
versus the Taperloc Complete Microplasty 
Protocol Number 
ORTHO.CR.GH60 
Short Protocol Title 
Randomized controlled study comparing the Taperloc Complete 
versus the Taperloc Complete Microplasty 
Sponsor 
Zimmer GmbH, Zählerweg 4, 6300 Zug, Switzerland 
Manufacturer 
Biomet Orthopedics, 56 East Bell Drive, Warsaw, Indiana 
46581 USA 
Study Device(s) 
Taperloc Complete Microplasty PPS-Bonemaster 
Taperloc Complete Reduced Distal PPS- Bonemaster 
Technical 
Documentation 
Reference Number 
Reference can be found on Post-market surveillance Plan 
(PMSP) 
Study 
Objectives/Endpoints 
Primary endpoint: 
Migration of the prosthesis over two years based on RSA data. 
Secondary endpoints: 
a. The prevalence of malalignment, incorrect sizing, 
subsidence and intraoperative fractures at the direct 
postoperative visit. 
b. Survival of the hip prosthesis within 2 years. 
c. Clinician based outcomes (HHS and radiological 
evaluation) and patient based outcomes (HOOS, 
EQ5D, Oxford Hip score, Forgotten Joint score) at each 
visit. 
Indications/Target 
Population 
Subjects with osteoarthritis of the hip scheduled for a primary 
total hip arthroplasty (THA) who are willing to participate in the 
study. Subjects have to meet all the in- and exclusion criteria of 
the study.  
Inclusion/Exclusion 
Criteria 
Inclusion criteria 
In order to be eligible to participate in this study, a subject must 
meet all of the following criteria. These are standard indications 
for usage of the Taperloc Complete and Taperloc Microplasty 
stem.  
Subjects with one of the following indications: 
• 
Non-inflammatory degenerative joint disease including 
osteoarthritis, avascular necrosis and rheumatoid 
arthritis.  
• 
Correction of functional deformity.  
Additional inclusion criteria include: 
• 
Male or female 
• 
≥ 18 and ≤ 70 years of age  
• 
Subjects willing to return for follow-up evaluations. 
• 
Subjects able to read and understand Dutch language.  
Exclusion criteria 
A potential subject who meets any of the following criteria will 
be excluded from participation in this study.  

Taperloc Complete Microplasty 
 
2017-07 - Rev. 1.5 
Protocol # ORTHO.CR.GH60 
 
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• 
active Infection (or within 6 weeks after infection) 
• 
Sepsis 
• 
Osteomyelitis 
• 
Uncooperative patient or patient with neurologic 
disorders who are incapable of following directions  
• 
diagnosed Osteoporosis or Osteomalacia 
• 
Metabolic disorders which may impair bone formation 
• 
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. 
Study Design 
A single-centre, randomized controlled post market surveillance 
study: 
• 
Group 1: Taperloc Complete PPS-Bonemaster, 
Reduced Distal, Type 1 Taper (n=25) 
• 
Group 2: Taperloc Complete Microplasty Reduced 
Distal, PPS-Bonemaster, Type 1 Taper (n=25) 
In both groups, the G7 acetabular cup is used with 
Polyethylene E1 articulation. 
Clinical Phase 
Post-market 
Sample Size  
50 subjects in total, 25 study subjects implanted with the study 
device per cohort.  
Length of Study 
3 years (1 year of enrolment and 2 years of follow-up) 
Materials and 
Methods 
All included patients will be assessed preoperatively and 
directly postoperative. Follow-up will take place at 6-weeks, 1 
and 2 years postoperatively.  
Data Collection 
Electronic 
Statistical Reporting 
Data collected will be summarized and reported to the 
participating investigator. Zimmer Biomet or its designee will 
conduct statistical analysis. Survivorship will be evaluated using 
Kaplan-Meier. Implant migration will be evaluated using 
Roentgen Stereogrammetric Analysis (RSA). 
Scores/Performance 
Assessments 
HHS, HOOS, EQ5D, Oxford Hip score, Forgotten Joint Score. 
Standards 
The PMCF is compliant with the below: 
• 
ISO 14155: 2020 - Clinical investigation of medical devices 
for human subjects - Good clinical practice. 
• 
The Declaration of Helsinki (DoH) - Ethical principles for 
medical research involving human subjects.  
Study Funding 
Zimmer Biomet makes funding for this clinical study available 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. 
 

Taperloc Complete Microplasty 
 
2017-07 - Rev. 1.5 
Protocol # ORTHO.CR.GH60 
 
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STATISTICAL METHOD 
Data will be analyzed using the “Statistical Package for the Sciences” version 20.0 or higher. Differences 
will be 2-tailed tested and alpha is set on 0.05. Data will be presented as per protocol (intention-to-treat) 
and as treated analysis (treatment eventually received). 
Descriptive analysis 
Descriptive analysis will be performed to report baseline characteristics and outcome measures. 
Continuous data (e.g. age, BMI,): mean ± SD or medians and IQR (depending on normality). 
Categorical data (e.g. gender, ASA): number and frequencies will be reported for treatment groups. 
The quantitative variables obtained from the clinical evaluation (HHS, HOOS, EQ-5D, Oxford Hip 
Score and Forgotten Joint Score) will be tabulated and analysed as mean, standard deviation, 
minimum and maximum values. Complications and other clinical relevant information will be 
documented as known variables. All outcomes will be reported with 95% confidence intervals. 
Primary and Secondary Endpoint Analysis 
Analysis for primary and secondary endpoints will use the patient population which consists of those 
cases with complete data for one or more of the primary and secondary endpoints. 
Survivorship 
Hip prosthesis survivorship will be assessed using a Kaplan-Meier analysis.  
 
Study Safety  
All adverse events will be recorded, described, and compared for the groups. Comparisons will use 
standard statistical tests (chi-square, Fisher’s exact). Adverse events resulting in device removal 
and/or revision and those not requiring device removal and/or revision will be summarized. Device 
related serious adverse events will be collected and evaluated for differences in the population.