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| Name | Class |
|---|---|
| Warmia and Mazury Oncology Centre | UNKNOWN |
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Patient-related outcomes were originally designed to measure outcomes in clinical studies. They were not developed to predict outcomes, however, different studies showed close association between values achieved preoperatively and postoperative outcomes. The aim of the present trial is to identify patients with satisfactory and unsatisfactory outcomes after joint replacement and to investigate whether there are any potential predicting potential in preoperative results of the patient-related outcomes and if there exist other predicting factors for functional recovery or treatment failure after joint replacement surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HIP_R | Patients undergoing hip replacement surgery |
| |
| KNEE_R | Patients undergoing knee replacement surgery |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Joint replacement | Procedure | Routinely performed hip- or knee replacement |
|
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of the patients' opinion about their hip. Change over time | Change between the following assessments as measured with the Hip disability and Osteoarthritis Outcome Score (HOOS) in patients undergoing total hip replacement; 0-100 points, worst to best; minimal clinical difference (MCD) = 10 points. | 12 months |
| Assessment of the patients' opinion about their knee. Score change over time | Change between the following assessments as measured with the Knee injury and Osteoarthritis Outcome Score (KOOS) in patients undergoing total knee replacement; 0-100 points, worst to best; minimal clinical difference (MCD) = 10 points. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of the quality of life. Score change over time | Results of the generic PROM, the Short Form Health Survey-36 (SF-36) in both, patients undergoing hip and knee replacement; 0-100 points, worst to best. | 12 months |
| Pain intensity. Change over time |
| Measure | Description | Time Frame |
|---|---|---|
| Body mass index (BMI) | Measurement of weight in kilograms and height in meters to combined to report BMI in kg/m^2; to be measured twice, before intervention and after 12 months. | 12 months |
| Activity |
Inclusion Criteria:
Patients with primary or secondary hip- and knee osteoarthritis undergoing joint replacement surgery.
Exclusion Criteria:
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Adult population with osteoarthritis of the hip or knee.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Przemysław T Paradowski, MD, PhD | Contact | +48575908432 | P.Paradowski@cm.umk.pl | |
| Marek K Gojło, MD, PhD | Contact | +48503084950 | marekgojlo@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ludwik Rydygier Collegium Medicum, Faculty of Health Sciences, Jagiellońska 13/15 | Recruiting | Bydgoszcz | PL-85-067 | Poland |
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| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| D015207 | Osteoarthritis, Hip |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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| ID | Term |
|---|---|
| D019643 | Arthroplasty, Replacement |
| D001178 | Arthroplasty |
| ID | Term |
|---|---|
| D019637 | Orthopedic Procedures |
| D013514 | Surgical Procedures, Operative |
| D019651 | Plastic Surgery Procedures |
| D019919 | Prosthesis Implantation |
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Measured with the Visual Analog Scale (VAS); 0-10 points, worst to best. |
| 12 months |
| Hip abductors muscle strength. Change over time | Determination of the Trendelenburg's sign in patients undergoing total hip replacement in following assessments; positive or negative. | 12 months |
| Range of motion. | Assessment of range of motion in hips and knees, respectively, in following assessments; degrees. | 12 months |
Measured with the Tegner Activity Score (TAS); 1-10 points, worst to best; to be measured twice, before intervention and after 12 months.
| 12 months |
| D012216 |
| Rheumatic Diseases |