BC Study of G7 Cup and Compatible Femoral Stems

NCT03456622 | Active Not Recruiting

• 1 other identifier: ORTHO.CR.GH59
• Study Type: observational
• Target: 230
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Non-inflammatory Degenerative Joint Disease; Osteoarthritis; Avascular Necrosis; Rheumatoid Arthritis

Keywords

G7

Outcome Measures

Primary Outcomes (1)

• Survival of the implant system

  Survival of the implant based on removal or intended removal of any component

  10 years post-surgery

Secondary Outcomes (8)

• Oxford Hip Score

  pre-op, 6 Months, 1 Year, 3 Year

• Harris Hip Score

  pre-op, 1 Year, 3 Year

• EQ-5D-3L score

  pre-op, 6 Months, 1 Year, 3 Year

• EQ-5D-3L VAS

  pre-op, 6 Months, 1 Year, 3 Year

• Hip disability and Osteoarthiritis Outcome Score (HOOS)

  pre-op, 6 Months, 1 Year, 3 Year

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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;

Sponsors & Collaborators

• Zimmer Biomet: lead

Study Sites (1)

The Royal Bournemouth Hospital

Bournemouth, BH7 7DW, United Kingdom

Location

MeSH Terms

Conditions

Osteoarthritis; Osteonecrosis; Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Bone Diseases; Necrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 10 Years
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 12, 2018
• First Posted: March 7, 2018
• Study Start: November 1, 2015
• Primary Completion (Estimated): June 1, 2029
• Study Completion (Estimated): December 1, 2030
• Last Updated: November 25, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)