BC Study of G7 Cup and Compatible Femoral Stems

November 19, 2025 updated by: Zimmer Biomet

A Prospective, Observational, Multi-centre, Cohort Study of the G7™Acetabular System Used With Compatible Femoral Stems in Patients With Degenerative Disease of the Hip

A prospective , observational, multi-centre, cohort study of the G7™ Acetabular System used with compatible femoral stems in patients with degenerative disease of the hip.

The study will be enrolled onto Beyond Compliance.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Detailed Description

The UK Beyond Compliance is a joint effort between implant manufacturers, implanting surgeons adopting our products, and the Beyond Compliance Advisory Group, all of whom are looking to ensure the safe and stepwise introduction of new or modified implants to the market in the interest of patients.

The G7 Acetabular Cup System is Biomet multi-bearing acetabular platform with a wide range of acetabular shell options recently launched. There is a need to provide evidence on the safety and performance of this cup to support the product in different markets.

The purpose of this multicenter study is to assess the clinical performance of the G7 acetabular system under standard condition of use. The data will help Biomet to gain 3A ODEP rating in 4 years and up to 10 year rating

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
230

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

  • United Kingdom
      • Bournemouth, United Kingdom, BH7 7DW
        • The Royal Bournemouth Hospital

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

All individuals who receive the study device, meet inclusion/exclusion criteria and provided nformed consent.

Description

Inclusion Criteria:

  • Male and female ≥18 years
  • Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis, suitable for unilateral primary hip replacement;
  • Rheumatoid arthritis;
  • Correction of functional deformity;
  • Voluntary written Informed Consent obtained

Exclusion Criteria

Pre-operative:

  • Prospect for recovery to independent mobility compromised by known coexistent medical problems;
  • Requiring revision hip replacement;
  • Requiring bilateral hip replacement;
  • Previous hip replacement (resurfacing or THR) on the contralateral side and whose outcome is achieving an Oxford Hip score <18 points;
  • Likely post-operative leg length inequality >5cm;
  • Neuromuscular disease affecting hip (Parkinson's, cerebral palsy, other spasticity);
  • Primary or metastatic tumour involving this hip;
  • Loss of abductor musculature, poor bone stock, or poor skin coverage around the hip joint;
  • Previous organ transplant;
  • Previous arthrodesis or excision arthroplasty

  • Abnormal acetabulum:

    • Acetabular deficiency - >2cm superior loss acetabular dome or >1.5cm protrusion acetabulae or wall deficiency> half a wall;
    • Dysplasia (DDH) with >2.5cm subluxation or complete dislocation;
  • Body mass index > 40kg/m2;
  • Active or previous or suspected infection in this hip;
  • Sepsis or osteomyelitis;
  • Known sensitivity to device materials;
  • Women judged by the investigator to be of childbearing potential who are pregnant, nursing, or planning to become pregnant, and those who do not agree to remain on an acceptable method of birth control throughout the entire study period;
  • Unable to provide informed consent (insufficient English, cognitive disorder such as dementia, psychiatric illness);
  • Unable to complete follow-ups (life expectancy <5 years, insufficient English, lives overseas, unable to return easily).

Intra-operative:

  • Abnormal abductor mechanism - trochanter escape > 1.5cm or gluteus medius totally non-functional or trochanter absence;
  • Unavailability of required size of prosthesis;

  • Abnormal acetabulum:

    • Acetabular deficiency - >2cm superior loss acetabular dome or >1.5cm protrusion acetabulae or wall deficiency> half a wall;
    • Dysplasia (DDH) with >2.5cm subluxation or complete dislocation.

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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Survival of the implant system
Time Frame: 10 years post-surgery
Survival of the implant based on removal or intended removal of any component
10 years post-surgery

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Radiographic assessment
Time Frame: 1 year post-op
Assessing radiolucency
1 year post-op
Oxford Hip Score
Time Frame: pre-op, 6 Months, 1 Year, 3 Year
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, 6 Months, 1 Year, 3 Year
Harris Hip Score
Time Frame: pre-op, 1 Year, 3 Year
The Harris Hip Score (HHS) is an outcome measure that includes a series ofquestions answered by the patient and physical examinations recorded by aqualified health care professional. The HHS covers four domains: pain (one item, 0-44 points), function and functional activities (seven items, 0-47 points), absence ofdeformity (one item, 0-4 points) and range of motion (one item, 0-5 points). Toobtain a final score, the points are summed. The outcome score can be categorizedas Excellent: 90-100; Good: 80-90; Fair: 70-80; Poor: < 70
pre-op, 1 Year, 3 Year
EQ-5D-3L score
Time Frame: pre-op, 6 Months, 1 Year, 3 Year
The EQ-5D-3L is a standardized instrument widely used to measure health status. It is a self-reported assessment about the patient's quality of life composed of two parts: a questionnaire and a visual analogue scale (VAS). The questionnaire includes five dimensions referring to mobility, self-care, daily activities,pain/discomfort, and anxiety/depression. Each question can be answered in three ways/levels indicating no problems, some problems, and extreme problems. In the derived EQ-5D-3L score, the highest score is 1 and the lowest score is -0.594; negative numbers correspond to a self-assessed health state worse than being dead.
pre-op, 6 Months, 1 Year, 3 Year
EQ-5D-3L VAS
Time Frame: pre-op, 6 Months, 1 Year, 3 Year
The EQ-5D-3L is a standardized instrument widely used to measure health status.It is a self-reported assessment about the patient's quality of life. It is a self-reported assessment about the patient's quality of life composed of two parts: a questionnaire and a visual analogue scale (VAS). The VAS is a vertical scale ranging from 100 ('The best health you can imagine') to 0 ('The worst health you can imagine') where the patient reports his/her current state of health.
pre-op, 6 Months, 1 Year, 3 Year
Hip disability and Osteoarthiritis Outcome Score (HOOS)
Time Frame: pre-op, 6 Months, 1 Year, 3 Year
The Hip disability and Osteoarthritis Outcome Score (HOOS) is a questionnaire designed to assess patient-relevant outcomes of hip related problems [Nilsdotter et al., 2003]. The HOOS covers five domains: pain (ten items), symptoms (five items), activity of daily living (17 items), sport/recreation function (four items), and hip-related quality of life (QoL) (four items). All items have five possible answer options scored from 0 (no problems) to 4 (extreme problems). The mean scores of each domain are transformed to a 0-100 scale, with 0 representing extreme hip problems and 100 representing no hip problems.
pre-op, 6 Months, 1 Year, 3 Year
Radiographic assessment
Time Frame: post-op, 2-8 weeks, 1 Year, 3 Year
Assessing radiolucency
post-op, 2-8 weeks, 1 Year, 3 Year
Safety of the implant system
Time Frame: 10 years post-surgery
Safety of the system will be assessed by monitoring the frequency and incidence of adverse events.
10 years post-surgery

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2015

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2029

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2030

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 12, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 6, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 7, 2018

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 19, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ORTHO.CR.GH59

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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