NCT03456622Active, not recruiting
BC Study of G7 Cup and Compatible Femoral Stems
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
Source: ClinicalTrials.gov · Last updated 25 Nov 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Observational
- Enrollment
- 230 (actual)
- First submitted
- 12 Jan 2018
- Start date
- 1 Nov 2015
- Primary completion date
- 30 Jun 2029
- Lead sponsor
- Zimmer Biomet
- Diseases
- Rheumatoid arthritis
- NCT number
- NCT03456622
What you commit to
- Study type: Observational
- Participants enrolled: 230
- From 1 Nov 2015 to the primary completion date, 30 Jun 2029
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous hip replacement (resurfacing or THR) on the contralateral side and whose outcome is achieving an Oxford Hip score \<18 points;
- Previous organ transplant;
- Previous arthrodesis or excision arthroplasty
- Active or previous or suspected infection in this hip;
Other illness
- Neuromuscular disease affecting hip (Parkinson's, cerebral palsy, other spasticity);
- Unable to provide informed consent (insufficient English, cognitive disorder such as dementia, psychiatric illness);
Age
- Unable to complete follow-ups (life expectancy \<5 years, insufficient English, lives overseas, unable to return easily).
- Intra-operative:
Other
- Pre-operative:
- Prospect for recovery to independent mobility compromised by known coexistent medical problems;
- Requiring revision hip replacement;
- Requiring bilateral hip replacement;
- Likely post-operative leg length inequality \>5cm;
- Primary or metastatic tumour involving this hip;
- Loss of abductor musculature, poor bone stock, or poor skin coverage around the hip joint;
- 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;
- 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;
- 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.
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The Royal Bournemouth Hospital Coordinator of this site? Confirm its status | Bournemouth | United Kingdom | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.