A Multicentre Observational Study to Evaluate Clinical Outcomes of the G7 Acetabular System

December 5, 2025 updated by: Zimmer Biomet
This is a prospective observational multi-center non-controlled study. The primary purpose of this study is to evaluate the clinical and radiographic performance of the G7 Acetabular Cup System.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is a prospective observational multi-center non-controlled study. The primary purpose of this study is to evaluate the clinical and radiographic performance of the G7 Acetabular Cup System in both primary and revision procedures, report safety and survivorship, and document instrument ease of use.

Preoperative and intraoperative data have been collected retrospectively and follow ups have been collected prospectively.

Clinical outcomes included the Harris Hip Score, Oxford Hip Score, and Radiographic Evaluations collected at 3 month, 1, 2 and 5 year follow-up time points. For the 7 and 10 year follow-up intervals, survivorship and adverse events have been collected.

Study Type

Observational

Enrollment (Actual)

162

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Clermont-Ferrand, France
        • Clermont-Ferrand Hospital
  • Germany
      • Würzburg, Germany
        • University of Würzburg, Orthopedic
  • Ireland
      • Limerick, Ireland
        • Midwestern Regional Orthopaedic Hospital
  • Netherlands
      • Delft, Netherlands
        • Reinier de Graaf Groep
  • Spain
      • Ponferrada, Spain
        • Hospital El Bierzo
  • United States
    • Arizona
      • Tucson, Arizona, United States, 85718
        • University Orthopedic Specialists

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Primary care clinic

Description

Inclusion Criteria:

  • 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
  • 18 years of age or older
  • Subjects willing to return for follow-up evaluations

Exclusion Criteria:

  • Infection, sepsis and osteomyelitis
  • Subjects unable to cooperate with and complete the study
  • Neurological conditions affecting movement
  • Pregnancy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Metal on Polyethylene articulation
G7 cup with Metal on Polyethylene articulation (MOP)
Device: Metal on Polyethylene articulation
G7 Acetabular Cup System with Metal head on Polyethylene liner articulation (MOP)
Other Names:
  • MOP
Ceramic on Polyethylene articulation
G7 cup with Ceramic on Polyethylene articulation (COP)
Device: Ceramic on Polyethylene articulation
G7 Acetabular Cup System with Ceramic head on Polyethylene liner articulation (COP)
Other Names:
  • COP
Ceramic on Ceramic articulation
G7 cup with Ceramic on Ceramic articulation (COC)
Device: Ceramic on Ceramic articulation
G7 Acetabular Cup System with Ceramic head on Ceramic linear articulation (COC) - Outside the United States ONLY
Other Names:
  • COC

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Harris Hip Score
Time Frame: Pre-operative,1, 2, and 5 years postoperatively
The Harris Hip Scale (HHS) is an outcome measure that includes a series of questions answered by the patient and physical examinations recorded by a qualified health care professional. The HHS covers four domains: pain (one item, 0-44 points), function and functional activities (seven items, 0-47 points), absence of deformity (one item, 0-4 points) and range of motion (one item, o-5 points). To obtain a final score, the points are summed. The outcome score can be categorized as Excellent:90 - 100; Good: 80 - 90; Fair: 70 - 80; Poor: < 70.
Pre-operative,1, 2, and 5 years postoperatively

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Oxford Hip Score
Time Frame: Pre-op, 1, 2, and 5 years postoperatively
The Oxford Hip Score (OHS) is a patient-reported outcome measure that was developed to specifically assess the patient's perspective of outcome following THA. The OHS consists of twelve questions covering function and pain associated with the hip. To calculate the total score, each response is scored from 0 (worst outcome) to 4 (best outcome) and the sum of all 12 items is reported with a maximum of 48, representing the best score possible. The outcome score can be categorized as Excellent: > 41; Good: 34 - 41; Fair: 27 - 33; Poor: < 27.
Pre-op, 1, 2, and 5 years postoperatively
Survivorship
Time Frame: 7 and 10 Year post-operative
Fraction of patients without a revision of any of the hip implant component, calculated with the Kaplan Meier (K-M) estimate.
7 and 10 Year post-operative
Survivorship
Time Frame: 10 Year post-operative
Fraction of patients without a revision of any of the hip implant component, calculated with the Kaplan Meier (K-M) estimate.
10 Year post-operative
Radiographic Evaluation
Time Frame: Immediate post-op, 3 months, 1, 2, and 5 years
All radiographs have been reviewed by the investigators at each site in order to detect and report any abnormal and significant findings (including adverse events). The change from the angle of inclination between the different follow-ups is shown in the table.
Immediate post-op, 3 months, 1, 2, and 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zimmer Biomet

Investigators

  • Study Director: Emilie Rohmer, Zimmer Biomet

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2013

Primary Completion (Actual)

December 1, 2024

Study Completion (Actual)

May 1, 2025

Study Registration Dates

First Submitted

January 14, 2014

First Submitted That Met QC Criteria

January 14, 2014

First Posted (Estimated)

January 15, 2014

Study Record Updates

Last Update Posted (Estimated)

December 19, 2025

Last Update Submitted That Met QC Criteria

December 5, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ORTHO.CR.GH20

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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