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Assessment of the clinical performance and survivorship of the Corin Total Hip System with Trinityâ„¢ cup MetaFixâ„¢ Collared stem in a prospective study. The primary endpoint of the study is to evaluate the 3-year survivorship and clinical performance of the Corin Total Hip System using Trinityâ„¢ cup and MetaFixâ„¢ Collared stem. Additionally, the study follow up will continue until 10 years for subjects who consent to do.
The primary objective is the 3-year survivorship of the study devices.
The Secondary Objectives include:
The improvement of clinical outcomes:
Safety performance monitoring including hip- and device-related AEs and the revision rate up to 10-year follow-up
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MetaFix Collared Stem | Device | Patients received the MetaFix Collared stem during there Total Hip Arthroplasty |
| Measure | Description | Time Frame |
|---|---|---|
| Post operative survivorship of MetaFix Collared Stem at 3-year follow-up | Survivorship measured via Kaplan-Meier (KM) curve. | 3 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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Patients requiring a THR were identified and screened according to the Indications for use and the contraindications for implantation of the MetaFixâ„¢ collared femoral stem and the Trinityâ„¢ acetabular cup were invited to consent to the study. No specific exclusion criteria were defined for this study.
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| Name | Affiliation | Role |
|---|---|---|
| Steve Barnett | Hoag Orthopedic Institute | Principal Investigator |
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| ID | Term |
|---|---|
| D015207 | Osteoarthritis, Hip |
| 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 disability and Osteoarthritis Outcome Score (HOOS) up to 10-year follow-up | The validated Hip disability and Osteoarthritis Outcome Score questionnaire is designed for patients with hip Osteoarthritis, it consists of 40 questions which assesses Pain, Symptoms, Activities of Daily Living, Sport and Recreational and Hip related Quality of life. To answer the questions, standardized answer options are given in 5 Likert-boxes with scores from 0 to 4 (no, mild, moderate, severe and extreme). To interpret the score, the outcome measure is transformed in a worst to best scale from 0 to 100, with 100 indicating no symptoms and 0 indicating extreme symptoms. | 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 |
| Post operative survivorship of MetaFix Collared Stem at 10-year follow-up | Survivorship measured via Kaplan-Meier (KM) curve. | Baseline to 10 years |
| MetaFix Collared Stem radiographic performance up to 10-years | Radiographic assessment considering radiolucent lines, stem alignment, heterotopic ossifications, osteolysis. | Baseline to 10 years |
| D012216 |
| Rheumatic Diseases |