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The aim of the study is to provide long term follow up data on the performance and safety of the Corin MiniHip and Trinity acetabular cup over a 10-year period.
To verify the ten-year clinical and radiographic performance of the Corin MiniHip and Trinity Advanced Bearing Acetabular System when used in patients under normal conditions of use.
To document the safety, evaluate patient satisfaction, quality of life and to determine the survivorship following intervention with the Corin MiniHip and Trinity Advanced Bearing Acetabular System at each follow-up visit.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MiniHip Stem | Device | The MiniHip stem is a titanium femoral stem (Ti-6Al-4V) coated with a layer of hydroxyapatite applied over a layer of pure titanium | ||
| Trinity Acetabular Cup System | Device | The Trinity Acetabular System is a modular acetabular cup system consisting of a press fit, titanium alloy shell |
| Measure | Description | Time Frame |
|---|---|---|
| Post operative survivorship of the Minihip Stem and Trinity acetabular Cup system at 10-year follow-up | Survivorship measured via Kaplan-Meier (KM) curve | 10 years |
| Measure | Description | Time Frame |
|---|---|---|
| Harris Hip Score (HHS) up to 10-year follow-up | Harris Hip Score is a disease-specific scoring system, originally intended as an outcome score after arthroplasty surgeries that includes the domains of function, pain, motion and deformity. Minimum score is 0, Maximum score is 100. The score is reported as 90-100 for excellent results, 80-89 for good, 70-79 for fair, 60-69 for poor, and below 60 for a failed result. |
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Inclusion Criteria:
Exclusion Criteria:
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Suitable participants undergoing primary total hip replacement with the Corin MiniHip and Trinity Advanced Bearing Acetabular System.
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| Name | Affiliation | Role |
|---|---|---|
| Richard Field | Elective Orthopaedic Centre, Epsom Hospital, Epsom, Surrey, KT18 7EG | Principal Investigator |
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| ID | Term |
|---|---|
| D015207 | Osteoarthritis, Hip |
| D000082602 | Developmental Dysplasia of the Hip |
| D005271 | Femur Head Necrosis |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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| Baseline to 10 years |
| Oxford Hip Score (OHS) up to 10-year follow-up | Oxford Hip Score is a patient-centered questionnaire that is designed to assess functional ability and pain from the patient's perspective. It is a short, twelve-item questionnaire developed for completion by patients undergoing THA. Minimum score 0 indicating worst outcome, maximum score 48 indicating best outcome. | Baseline to 10 years |
| Hip- and device-related adverse events up to 10-year follow-up | All hip-related and device-related complications, including those occurring during the surgical procedure and throughout the postoperative evaluations, are required to be documented and reviewed | Baseline to 10 years |
| Trinity acetabular cup radiographic performance up to 10-years | Radiographic assessment considering Acetabular radiolucent lines using the De lee Charney measurement of zones 1 - 3. | Baseline to 10 years |
| Minihip Stem radiographic performance up to 10-years | Radiographic assessment considering osteolysis and femoral stem alignment measured as Varus/Valgus and the use of the Gruen's assessment zones 1-7 | Baseline to 10 years |
| Minihip Stem and Trinity acetabular cup radiographic performance up to 10-years | Radiographic assessment considering heterotopic ossifications using the Brooker classification Grade 1 - 4. | Baseline to 10 years |
| D012216 |
| Rheumatic Diseases |
| D006617 | Hip Dislocation |
| D004204 | Joint Dislocations |
| D009139 | Musculoskeletal Abnormalities |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D010020 | Osteonecrosis |
| D001847 | Bone Diseases |
| D009336 | Necrosis |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |