BC Study of G7 Cup and Compatible Femoral Stems

Study Overview
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Brief Summary
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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.

Detailed Description
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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

Official Title
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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

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

Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of failure. | The survival function of the device will be estimated using Kaplan-Meier methods | 3 years | 
| Rate of failure. | The survival function of the device will be estimated using Kaplan-Meier methods | 5 years | 
| Rate of failure. | The survival function of the device will be estimated using Kaplan-Meier methods | 10 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Oxford Hip Score | Assessing function outcome - Oxford Hip Score, score range 0 (worst) to 48 (best) | Change from pre-op score at 1 year post-op | 
| Oxford Hip Score | Assessing function outcome - Oxford Hip Score, score range 0 (worst) to 48 | 3 years after primary device implantation | 
| Harris Hip Score questionnaire | Assessing function outcome - Harris Hip Score - score range 90 - 100 (excellent), 80 - 90 (good), 70 - 79 (fair), 60 - 69 (poor) and under 60 (very poor) | Change from pre-op score at 1 year post-op | 
| Harris Hip Score questionnaire | Assessing function outcome - Harris Hip Score - score range 90 - 100 (excellent), 80 - 90 (good), 70 - 79 (fair), 60 - 69 (poor) and under 60 (very poor) | Change from pre-op score at 3 year post-op | 
| EuroQol Five Dimensions Questionnaire (EQ-5D-3L) | Reporting on quality of life - scores range from -0.11 (i.e., 33333) to 1.0 (i.e., 11111) on scale where 0.0 =death and 1.0 =perfect health. | Change from pre-op score at 1 year post-op | 
| EuroQol Five Dimensions Questionnaire (EQ-5D-3L) | Reporting on quality of life - scores range from -0.11 (i.e., 33333) to 1.0 (i.e., 11111) on scale where 0.0 =death and 1.0 =perfect health. | Change from pre-op score at 3 year post-op | 
| Hip disability and Osteoarthiritis Outcome Score (HOOS) | Patient Reported Outcome - score range 0 (worst ) to 100 (best) | Change from pre-op score at 1 year post-op | 
| Hip disability and Osteoarthiritis Outcome Score (HOOS) | Patient Reported Outcome - score range 0 (worst ) to 100 (best) | Change from pre-op score at 3 year post-op | 
| Radiographic assessment | Assessing radiolucency | 1 year post-op | 
| Radiographic assessment | Assessing radiolucency | 3 year post-op | 
| Adverse Event Reporting | Patient reported event. | recorded at pre-op, prior to discharge, 2-8 weeks, 6 months, 1 year, 3 years, 5 years & 10 years. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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G7