Study Evaluating the Efficacy of Joint Replacement

Study Overview
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Brief Summary
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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.

Official Title
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Assessment of Clinical Outcome Following Total Hip and Knee Replacement

Conditions
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Osteoarthritis, Knee, Osteoarthritis, Hip

Intervention / Treatment
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* Procedure: Joint replacement


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with primary or secondary hip- and knee osteoarthritis undergoing joint replacement surgery. Exclusion Criteria: An inability to understand the Polish language, Presence of neuromuscular disease and cognitive impairment, Having a prosthesis in another joint of the ipsilateral or contralateral lower limb placed within 6 months before the current surgery, Having rheumatoid arthritis, Symptoms in several joints (hip, knee or ankle) with expected total joint arthroplasty within 1 year.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| HIP_R<br>Patients undergoing hip replacement surgery | Procedure: Joint replacement<br>* Routinely performed hip- or knee replacement<br>* Other names: Joint arthroplasty;|
| KNEE_R<br>Patients undergoing knee replacement surgery | Procedure: Joint replacement<br>* Routinely performed hip- or knee replacement<br>* Other names: Joint arthroplasty;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Replacement, Arthroplasty, Patient-relevant outcome measure (PROM), KOOS, HOOS