BC Study of G7 Cup and Compatible Femoral Stems
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.

 The study will be enrolled onto Beyond Compliance.
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 safe and stepwise introduction of new or modified implants to the market in the
 interest of patients.

 The G7 Acetabular Cup System is Biomet multi-bearing acetabular platform with a wide range of
 acetabular shell options recently launched. There is a need to provide evidence on the safety
 and performance of this cup to support the product in different markets.

 The purpose of this multicenter study is to assess the clinical performance of the G7
 acetabular system under standard condition of use. The data will help Biomet to gain 3A ODEP
 rating in 4 years and up to 10 year rating
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.