A Multicentre Observational Study to Evaluate Clinical Outcomes of the G7 Acetabular System
Conditions: Noninflammatory Degenerative Joint Disease, Rheumatoid Arthritis
Sponsor: Zimmer Biomet

 
 
G7 Early Evaluator  
Protocol number: ORTHO.CR.GH20.13 
 
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A Multicentre Observational Study to Evaluate 
Clinical Outcomes of the G7TM Acetabular 
System 
 
 
Protocol number: ORTHO.CR.GH20.13 
Protocol date: 26 June 2013 
NCT number: NCT02036931 
 
 
 

 
 
G7 Early Evaluator  
Protocol number: ORTHO.CR.GH20.13 
 
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STUDY SYNOPSIS 
 
Complete Protocol Title 
A Multicentre Observational Study to Evaluate Clinical 
Outcomes of the G7TM Acetabular System 
Protocol Number 
ORTHO.CR.GH20.13 
Short Protocol Title 
G7 Early Evaluator 
Sponsor 
Zimmer GmbH 
Manufacturer 
Biomet Inc.; Biomet UK Ltd 
Study Device(s) 
G7 Acetabular Cup System 
Study Objectives/Endpoints 
The purpose of this multicenter study is to document the 
Clinical and Radiographic performance of the cup in both 
primary and revision procedures at the follow-up time 
points of 3 months, 1 year, 2 years, and 5 years and to 
report safety and Survivorship at 7 and 10 years follow-up. 
 
Primary endpoint: Harris Hip Score (HHS) at 2 year 
postoperative 
 
Secondary endpoints: 
a. Oxford Hip Score at 1,2,5 year postop 
b. Radiographic Evaluation: radiographic outcome, 
stability, incidence of radiolucencies around the prosthesis 
and bone remodeling 
c. Adverse Events/Complications (including 
revisions/removals of the study hip). 
d. Survivorship 
Indications/Target Population 
Subjects who have received G7 with one of three 
articulations (MOP, COP, COC) in primary or revision 
procedure and match with the indications for use. 
Inclusion/Exclusion Criteria 
Inclusion Criteria 
Selection of subjects for this evaluation should be in 
accordance with the indications of the G7 cup specifically:  
Subjects with one of the following indication:  
- 
 Noninflammatory degenerative joint disease including 
osteoarthritis and avascular necrosis. 
- 
Rheumatoid arthritis.  
- 
Correction of functional deformity.  
- 
Treatment of non-union, femoral neck fracture, and 
trochanteric fractures of the proximal femur with head 
involvement, unmanageable by other techniques.  
- 
Revision procedures where other treatment or devices 
have failed.  
 

 
 
G7 Early Evaluator  
Protocol number: ORTHO.CR.GH20.13 
 
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Additional inclusion criteria include:  
- 
Male or female.  
- 
18 years of age or older  
- 
Subjects willing to return for follow-up evaluations.  
Subjects who read, understand study information and 
give written consent (specific local regulatory) 
 
Exclusion Criteria 
Exclusion criteria should be in accordance with 
Contraindications for the G7 cup.  
Absolute contraindications include: infection, sepsis and 
osteomyelitis,  
Additional contraindications include:  
- 
Subjects unable to cooperate with and complete the 
study  
- 
Dementia and inability to understand and follow 
instructions  
- 
Neurological conditions affecting movement  
- 
Pregnancy  
Study Design 
Prospective/Retrospective Observational Multi-Center 
Non-Controlled post market surveillance study 
Clinical Phase 
Post-market 
Sample Size  
A sample size of 101 per group gives 80% power to detect 
a difference in means for each of the three comparisons. 
Length of Study 
11 years (1-year enrolment, with a follow-up of 10 years) 
Materials and Methods 
Case report forms will be completed either in-office or 
hospital at Pre-op, Intra-Operative, Immediate Post-
Operative, and the 3 Months, 1, 2, 5, 7 and 10-year 
intervals.  
Data Collection 
Paper/Electronic 
Statistical Reporting 
Statistical analysis will be conducted by Zimmer Biomet or 
its designee. Survivorship will be evaluated using Kaplan-
Meier. 
Scores/Performance Assessments 
(modified) Harris Hip Score, Oxford Hip Score, 
Radiographic Evaluations 
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. 

 
 
G7 Early Evaluator  
Protocol number: ORTHO.CR.GH20.13 
 
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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.