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The principal objectives of the study are to evaluate early and mid-term fixation of the REDAPT revision hip stem and acetabular cup as measured by stem subsidence and proximal cup migration at 2 and 5 years post-surgery through model-based RSA. Secondary objectives include; evaluate the progression of migration between 1 and 2 years and between 2 and 5 years, assess pre- to post-surgery patient improvement in function and health status, evaluate femoral and acetabular radiolucency at 2 and 5 years, and assess patterns of stem migrate on for different revision scenarios (preservation of the trochanters and extended trochanteric osteotomy).
This is a prospective, single arm, consecutive series study of patients undergoing revision hip arthroplasty. Patients will be grouped based on the revision implants they receive during surgery. Patients who receive a full hip revision (stem and cup), will be counted in both study groups. The two study groups are:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hip revision | Other | Revision to cup and stem, cup only or stem only. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Full revision | Device | Both cup and stem require revision |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in RSA Migrations from baseline(2-week) to 6-month, 1-year and 2-year | Stability over a period of two year measured by migration with Röntgen Stereometric Analysis | Post-op: 2-week, 6-month, 1-year, 2-year |
| 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. | Pre-op, Post-op (6 months, 1 year, and 2 years) |
| 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. | Pre-op, Post-op (6 months, 1 year, and 2 years) |
| Change is Pain VAS from baseline(pre-op) to 6-month, 1-year and 2-year | Evaluate and compare the change from preoperative to 2 years between the study groups timepoints in patient reported satisfaction as measured using the visual analogue scale (VAS) from 0 (No pain) - 100 (Worst pain imaginable) | Pre-op, Post-op (6 months, 1 year, and 2 years) |
| Changes in Patient Satisfaction (Likert scale) from baseline(pre-op) to 6-month, 1-year and 2-year | Patient satisfaction with their hip surgery will be assessed using a 5-point Likert scale: Very Unsatisfied (1), Unsatisfied (2), Neutral (3), Satisfied (4), and Very Satisfied (5). | Pre-op, Post-op (6 months, 1 year, and 2 years) |
| Measure | Description | Time Frame |
|---|---|---|
| Stem subsidence | Comparing RSA exams at the specified time points to determine relative movement of the REDAPT hip stem | 1-year, 2-year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Thomas Turgeon, MD | Concordia Joint Replacement Group | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Concordia Hospital | Winnipeg | Manitoba | R2K 3S8 | Canada |
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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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| Cup revision |
| Device |
Only the cup requires revision |
|
| Stem revision | Device | Only the stem requires revision |
|
| D012216 |
| Rheumatic Diseases |