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| Name | Class |
|---|---|
| Orthopaedic Innovation Centre | OTHER |
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The purpose of this study is to assess the migration pattern of the Insignia hip stem using radiostereometric analysis (RSA for short) and computed tomography (CT). Only patients with degenerative joint disease requiring primary total hip replacement will be asked to participate. The other purpose is to assess if there are any differences between the gold-standard RSA-measured migration and CT-RSA-measured migration. The clinical outcomes will be measured using joint function and patient satisfaction questionnaires. Approximately thirty patients will be enrolled onto the study.
This is a single-centre, non-randomized, non-controlled trial of patients undergoing primary total hip arthroplasty using the Insignia hip stem. Patients will undergo RSA and CT-RSA imaging and analyses to identify migration of the femoral stem with respect to the adjuvant bone during the first 2 post-operative years.
The primary outcome of this study is to determine if femoral stem stability is achieved between 6-12 month and 12-24 month post-operative intervals.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Insignia | Other | Total hip replacement CT-RSA vs gold standard RSA |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Insignia | Device |
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| Measure | Description | Time Frame |
|---|---|---|
| Migration | Quantify migration of the Insignia stem using RSA and CT-RSA | Up to 2 years post-operative |
| Measure | Description | Time Frame |
|---|---|---|
| Validation | Comparison of RSA and CT-RSA using the standard deviation of the mean component migration calculated from examinations. | Up to 2 years post-operative |
| Early migration | Quantify early migration of the Trident acetabular cup using RSA |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Eric R Bohm, MD | Orthopaedic Innovation Centre | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Concordia Hip & Knee Institute | Winnipeg | Manitoba | R2K 2M9 | Canada |
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| Up to 2 years post-operative |
| Changes in Oxford-12 Hip Score from baseline(pre-op) to 6-month, 1-year and 2-year | The Oxford Hip Score (OHS) is a patient self-administered 12-item questionnaire with each question having a Likaert-like response option. Each item is scored from 0 to 4, and the items are summated, with lower total scores indicating poorer performance. The OHS measures pain and general activities of daily living | Up to 2 years post-operative |
| Changes in EQ-5D-5L from baseline(pre-op) to 6-month, 1-year and 2-year | The EuroQol 5D 5L questionnaire is a standardized instrument for use as a measure of health outcome that is designed for completion by the subject. | Up to 2 years post-operative |
| Changes in Patient Satisfaction (VAS) from baseline(pre-op) to 6-month, 1-year and 2-year | Evaluate and compare the change from preoperative to 2 years in patient reported satisfaction as measured using the visual analogue scale (VAS) from 0 (Unsatified) - 100 (Completely Satisfied). | Up to 2 years post-operative |