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Pre-Operative Exercise Therapy and Patient Education Before Total Knee Replacement - Trial NCT06290336

Access comprehensive clinical trial information for NCT06290336 through Pure Global AI's free database. This phase not specified trial is sponsored by Linkoeping University and is currently Recruiting. The study focuses on Knee Osteoarthritis. Target enrollment is 110 participants.

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NCT06290336
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Trial Details
ClinicalTrials.gov โ€ข NCT06290336
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Pre-Operative Exercise Therapy and Patient Education Before Total Knee Replacement
Pre-operative Exercise Therapy and Patient Education Before Total Knee Replacement - Effect on Subjective Knee Function, Patient Satisfaction and Enablement

Study Focus

Knee Osteoarthritis

Pre-operative exercise therapy and education

Interventional

other

Sponsor & Location

Linkoeping University

Linkoping, Sweden

Timeline & Enrollment

N/A

Dec 20, 2023

Dec 30, 2026

110 participants

Primary Outcome

Change in Forgotten Joint Score-12 (FJS-12) from baseline to 1 year after surgery,Patient satisfaction at 1 year after surgery,Change in modified Patient Enablement Instrument-2 (Mod-PEI-2) from baseline to 6 weeks after surgery,Change in maximal isometric knee extension in 90 degrees of flexion from baseline to 6 weeks after surgery,Change in active knee range of motion from baseline to 6 weeks after surgery,Change in 30 seconds Chair to Stand-Test (30sCST) from baseline to 6 weeks after surgery

Summary

The goal of this multi-center randomized controlled trial is to investigate the effect of
 pre-operative exercise therapy and education for patients awaiting knee replacement surgery
 on subjective knee function, patient satisfaction and enablement compared to standard care.
 
 The main questions it aims to answer are:
 
 - Does pre-operative exercise therapy and education lead to better subjective knee
 function compared to standard care one year after surgery?
 
 - Does pre-operative exercise therapy and education lead to a higher level of patient
 satisfaction compared to standard care one year after surgery?
 
 - Does pre-operative exercise therapy and education lead to better patient enablement
 compared to standard care six weeks after surgery?
 
 - Does pre-operative exercise therapy and education lead to better objective knee function
 compared to standard care six weeks after surgery?
 
 Participants will be randomized stratified by age (โ‰ค 67 years, 67 years) to either
 pre-operative supervised individualized exercise therapy combined with education two
 sessions/week (intervention group) or to standard care (control group). The intervention will
 be continuously ongoing for at least eight weeks from the point of decision for surgery until
 as close to the surgery as possible.

ICD-10 Classifications

Chronic instability of knee
Gonarthrosis [arthrosis of knee]
Other hypertrophic osteoarthropathy
Dislocation, sprain and strain of joints and ligaments of knee
Patellofemoral disorders

Data Source

ClinicalTrials.gov

NCT06290336

Non-Device Trial