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The study will evaluate the radiographs (x-rays) of 100 patients with a TriFIT total hip at 2 weeks, 3 months, 6 months, 12 months, and yearly following surgery to see if there has been any movement or wear in the hip stem over the course of the study. The study will also record clinical data on each patient using various functional tests and questionnaires at the same intervals.
The present study will prospectively recruit 100 patients scheduled for elective total hip replacement with Corin's TriFIT Hip System at the Ottawa Hospital - General Campus. As part of their clinical care, patients routinely undergo a clinical examination and have had radiographs taken at 2 weeks, 3 months, 6 months, 12 months, and yearly following surgery. Using specialized software, radiographs from each interval will be examined to assess femoral stem migration and joint wear patterns. Femoral stem migration will be assessed using computer-assisted software. The study will also assess the rate of implant failure during the first two post-operative years. Clinical assessments and questionnaires will also be completed during each of the follow-up intervals.
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| Measure | Description | Time Frame |
|---|---|---|
| Femoral Stem Migration Radiographic Assessment | Femoral stem migration (in millimeters (mm)) will be assessed using computer-assisted Einzel Bild Roentgen Analyze-Femoral Component Analysis (EBRA-FCA) software and radiographs taken at each interval. | 2 weeks to end of study (approximately 2 years) post-operatively |
| Rate of Implant Failure | The number of revisions will be recorded. | 2 weeks to end of study (approximately 2 years) post-operatively |
| Radiographic Assessment of Wear in the Acetabular Components | Anterior-posterior (AP) and lateral radiographs from each follow-up visit will be used to assess wear of the acetabular (hip) components. | 2 weeks to end of study (approximately 2 years) post-operatively |
| Measure | Description | Time Frame |
|---|---|---|
| Harris Hip Score (HHS) | A standardized set of questions and measurements to assess the function of the hip. It includes pain, function, range of motion (ROM), and absence of deformity. | 2 weeks to end of study (approximately 2 years) post-operatively |
| Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) |
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Inclusion Criteria:
Exclusion Criteria:
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The first 100 patients Dr. Paul Beaule undergoing a total hip replacement with Corin's TriFIT Total Hip replacement system that meet the eligibility requirements and consent to do the study.
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| Name | Affiliation | Role |
|---|---|---|
| Paul Beaule, MD | Ottawa Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ottawa Hospital - General Campus | Ottawa | Ontario | K1H 8L6 | Canada |
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| ID | Term |
|---|---|
| D015207 | Osteoarthritis, Hip |
| D006618 | Hip Dislocation, Congenital |
| D010020 | Osteonecrosis |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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A standardized set of questions and measurements to assess the function of the hip. It includes pain, stiffness, and joint function. |
| 2 weeks to end of study (approximately 2 years) post-operatively |
| SF (Short Form)-12 Questionnaire | A subject-completed questionnaire with questions and he/she's health and well-being. | 2 weeks to end of study (approximately 2 years) post-operatively |
| UCLA (University of California, Los Angeles) Activity Level | A subject-completed questionnaire which asks his/her current activity level. | 2 weeks to end of study (approximately 2 years) post-operatively |
| D012216 |
| Rheumatic Diseases |
| D000082602 | Developmental Dysplasia of the Hip |
| D009139 | Musculoskeletal Abnormalities |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D001847 | Bone Diseases |
| D009336 | Necrosis |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |