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Multi-Centre Study in patients undergoing Total Hip Arthroplasty with the Smith+Nephew CATALYSTEMâ„¢ Primary Hip System. The primary objective is to establish the mean inferior stem migration (subsidence) of the CATALYSTEMâ„¢ stem using CT-RSA over the first two postoperative years.
This study is designed as a prospective, multi-center, non-controlled study of subjects implanted with the CATALYSTEMâ„¢ Primary Hip System for primary Total Hip Arthroplasty (THA). Subjects will be enrolled and followed for 2 years post-operatively.
Radiostereometric analysis (RSA) is a tool to measure implant migration, originally developed in the 1970s. It is now well-established that early migration (micromotion) of implants with respect to bone is a predictor for later aseptic loosening. Traditional RSA used dual x-ray to estimate implant migration and has been standardized. CT-based methods (CT-RSA), which do not require metal reference beads have been developed since, and have been validated with equivalent results. International guidelines have since been updated to reflect this move to CT-RSA.
The primary objective is to establish the mean inferior stem migration (subsidence) of the CATALYSTEMâ„¢ stem using CT-RSA over the first two postoperative years.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CATALYSTEM | Other | CATALYSTEM Hip Replacement System |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CATALYSTEM | Device | CATALYSTEM Cementless Primary Hip System for participants with Total Hip Arthroplasty |
|
| Measure | Description | Time Frame |
|---|---|---|
| Migration - CATALYSTEM Stem | CT-RSA software (V3MA, Leiden, Netherlands) will be used for the analysis of CT images based on extracted 3-dimensional computer models of the Catalystem stem and surrounding bone from the images to represent the respective rigid bodies. | 2 Years |
| Measure | Description | Time Frame |
|---|---|---|
| Subsidence - CATALYSTEM Stem | RSA measured subsidence of the CATALYSTEM stem at 6 months and 1 year and to compared to literature values of other stems, using t-test where appropriate. | 6 months and 1 Year |
| Other RSA measurements - CATALYSTEM stem |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sarah Tran | Contact | 204-926-1231 | stran@orthoinno.com | |
| Shalini Hari Kumar | Contact | 204-926-1232 | skumar@orthoinno.com |
| Name | Affiliation | Role |
|---|---|---|
| Thomas Turgeon, MD | University of Manitoba | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Orthopaedic Innovation Centre | Winnipeg | Manitoba | R2K 2M9 | 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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Other RSA measurements of the Emphasys Stem (X and Z translations in mm, X, Y, and Z rotations in degrees, and maximal total point motion in mm) at all time points. These endpoints will be compared to literature values of other stems, using t-test where appropriate.
| 6 Weeks, 6 Months, 1 Year and 2 Years |
| Oxford Hip Score | 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-operative (baseline), 6 Weeks, 6 Months, 1 Year and 2 Years |
| Forgotten Joint Score (FJS-12) | Functional and health status will be measured with the Forgotten Joint Score (FJS-12). The FJS total score range is 0-100, higher scores indicating the patient is able to forget the joint daily lower degree of joint awareness. | 6 Weeks, 6 Months, 1 Year and 2 Years |
| European Quality of Life (EQ-5D-5L) | EQ5D consists of 5 subscales; Mobility, Self-care, Usual activities, Pain/Discomfort and Anxiety / depression. A health state score is obtained based on the responses from 1-5 in each subscale, from which a single index value is calculated representing patients' overall health state. EQ5D includes a so called EQ VAS score which is the patients' self-rated health on a 20 cm vertical, visual analogue scale with endpoints labelled "the best health you can imagine" and "the worst health you can imagine". | Pre-operative (baseline), 6 Weeks, 6 Months, 1 Year and 2 Years |
| Patient Satisfaction (VAS) | Evaluate and compare the change from preoperative to 2 years between the timepoints in patient-reported Satisfaction as measured using the visual analogue scale (VAS) from 0 (Unsatisfied) - 100 (Completely satisfied) | Pre-operative (baseline), 6 Weeks, 6 Months, 1 Year and 2 Years |
| Complication | Evaluate the type and frequency of the complications/adverse events. | Pre-operative (baseline), 6 Weeks, 6 Months, 1 Year and 2 Years |
| D012216 |
| Rheumatic Diseases |