Clinical trial NCT03456622: BC Study of G7 Cup and Compatible Femoral Stems
Official title: 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
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Non-inflammatory Degenerative Joint Disease
Osteoarthritis
Avascular Necrosis
Rheumatoid Arthritis
Keywords: G7
Lead sponsor: Zimmer Biomet
Sponsor class: INDUSTRY
First posted: 2018-03-07
Enrollment: 230
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All individuals who receive the study device, meet inclusion/exclusion criteria and provided nformed consent.

Brief summary: 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: 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

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.

Primary outcomes:
measure: Survival of the implant system
timeFrame: 10 years post-surgery
Secondary outcomes:
measure: Oxford Hip Score
timeFrame: pre-op, 6 Months, 1 Year, 3 Year
measure: Harris Hip Score
timeFrame: pre-op, 1 Year, 3 Year
measure: EQ-5D-3L score
timeFrame: pre-op, 6 Months, 1 Year, 3 Year
measure: EQ-5D-3L VAS
timeFrame: pre-op, 6 Months, 1 Year, 3 Year
measure: Hip disability and Osteoarthiritis Outcome Score (HOOS)
timeFrame: pre-op, 6 Months, 1 Year, 3 Year
measure: Radiographic assessment
timeFrame: 1 year post-op
measure: Radiographic assessment
timeFrame: post-op, 2-8 weeks, 1 Year, 3 Year
measure: Safety of the implant system
timeFrame: 10 years post-surgery
Other outcomes:
Locations:
city: Bournemouth
country: United Kingdom
facility: The Royal Bournemouth Hospital
Study officials:
References: