BC Study of G7 Cup and Compatible Femoral Stems (NCT03456622) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
BC Study of G7 Cup and Compatible Femoral Stems
United Kingdom230 participantsStarted 2015-11
Plain-language summary
A prospective , observational, multi-centre, cohort study of the G7â„¢ Acetabular System used with compatible femoral stems in patients with degenerative disease of the hip.
The study will be enrolled onto Beyond Compliance.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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…