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
Study Type
OBSERVATIONAL
Enrollment
230
The Royal Bournemouth Hospital
Bournemouth, United Kingdom
Survival of the implant system
Survival of the implant based on removal or intended removal of any component
Time frame: 10 years post-surgery
Oxford Hip Score
The Oxford Hip Score (OHS) is a patient-reported outcome measure that was developed to specifically assess the patient's perspective of outcome following THA. The OHS consists of twelve questions covering function and pain associated with the hip. To calculate the total score, each response is scored from 0 (worst outcome) to 4 (best outcome) and the sum of all 12 items is reported with a maximum of 48, representing the best score possible. The outcome score can be categorized as Excellent: \> 41; Good: 34 - 41; Fair: 27 - 33; Poor: \< 27
Time frame: pre-op, 6 Months, 1 Year, 3 Year
Harris Hip Score
The Harris Hip Score (HHS) is an outcome measure that includes a series ofquestions answered by the patient and physical examinations recorded by aqualified health care professional. The HHS covers four domains: pain (one item, 0-44 points), function and functional activities (seven items, 0-47 points), absence ofdeformity (one item, 0-4 points) and range of motion (one item, 0-5 points). Toobtain a final score, the points are summed. The outcome score can be categorizedas Excellent: 90-100; Good: 80-90; Fair: 70-80; Poor: \< 70
Time frame: pre-op, 1 Year, 3 Year
EQ-5D-3L score
The EQ-5D-3L is a standardized instrument widely used to measure health status. It is a self-reported assessment about the patient's quality of life composed of two parts: a questionnaire and a visual analogue scale (VAS). The questionnaire includes five dimensions referring to mobility, self-care, daily activities,pain/discomfort, and anxiety/depression. Each question can be answered in three ways/levels indicating no problems, some problems, and extreme problems. In the derived EQ-5D-3L score, the highest score is 1 and the lowest score is -0.594; negative numbers correspond to a self-assessed health state worse than being dead.
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Time frame: pre-op, 6 Months, 1 Year, 3 Year
EQ-5D-3L VAS
The EQ-5D-3L is a standardized instrument widely used to measure health status.It is a self-reported assessment about the patient's quality of life. It is a self-reported assessment about the patient's quality of life composed of two parts: a questionnaire and a visual analogue scale (VAS). The VAS is a vertical scale ranging from 100 ('The best health you can imagine') to 0 ('The worst health you can imagine') where the patient reports his/her current state of health.
Time frame: pre-op, 6 Months, 1 Year, 3 Year
Hip disability and Osteoarthiritis Outcome Score (HOOS)
The Hip disability and Osteoarthritis Outcome Score (HOOS) is a questionnaire designed to assess patient-relevant outcomes of hip related problems \[Nilsdotter et al., 2003\]. The HOOS covers five domains: pain (ten items), symptoms (five items), activity of daily living (17 items), sport/recreation function (four items), and hip-related quality of life (QoL) (four items). All items have five possible answer options scored from 0 (no problems) to 4 (extreme problems). The mean scores of each domain are transformed to a 0-100 scale, with 0 representing extreme hip problems and 100 representing no hip problems.
Time frame: pre-op, 6 Months, 1 Year, 3 Year
Radiographic assessment
Assessing radiolucency
Time frame: 1 year post-op
Radiographic assessment
Assessing radiolucency
Time frame: post-op, 2-8 weeks, 1 Year, 3 Year
Safety of the implant system
Safety of the system will be assessed by monitoring the frequency and incidence of adverse events.
Time frame: 10 years post-surgery