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BC Study of G7 Cup and Compatible Femoral Stems

Active Not RecruitingN/A

Sponsor: Zimmer Biomet

Conditions: Non-inflammatory Degenerative Joint Disease, Osteoarthritis, Avascular Necrosis, Rheumatoid Arthritis

Countries: United Kingdom

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 overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: OBSERVATIONAL

Eligibility criteria

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.

Locations (1)

Bournemouth, United Kingdom