Status:
ACTIVE_NOT_RECRUITING
BC Study of G7 Cup and Compatible Femoral Stems
Lead Sponsor:
Zimmer Biomet
Conditions:
Non-inflammatory Degenerative Joint Disease
Osteoarthritis
Eligibility:
All Genders
18+ years
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 ...
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 saf...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
November 1 2015
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 1 2030
Estimated Enrollment :
230 Patients enrolled
Trial Details
Trial ID
NCT03456622
Start Date
November 1 2015
End Date
December 1 2030
Last Update
November 25 2025
Active Locations (1)
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1
The Royal Bournemouth Hospital
Bournemouth, United Kingdom, BH7 7DW