Clinical Trials in the UK / NCT03456622
Active, not recruiting
Observational
BC Study of G7 Cup and Compatible Femoral Stems
NCT03456622 · tracked via the Priya Life Science UK tracker
Condition(s) studied
Non-inflammatory Degenerative Joint DiseaseOsteoarthritisAvascular NecrosisRheumatoid Arthritis
Study 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.
Eligibility
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.
Primary outcome measure(s)
- Survival of the implant system — 10 years post-surgery
Survival of the implant based on removal or intended removal of any component
Trial sites (1)
| Facility | City | Region | Status |
|---|---|---|---|
| The Royal Bournemouth Hospital | Bournemouth | United Kingdom |
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Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT03456622 on ClinicalTrials.gov ↗ ← All trials in the UK