Rehabilitation After Fast-track Total Knee Arthroplasty

Study Overview
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Brief Summary
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BACKGROUND In 2008 approximately 7,700 total knee arthroplasties (TKA) were performed in Denmark. The results after TKA is in general very good, the investigators have, however, discovered that patients following fast-track TKA still have a deficit 12 months postoperatively of 5-10% in health-related quality-of-life and 15-20% in activity and participation when compared to age- and gender matched population. A postoperative rehabilitation intervention has the potential to reduce or remove this observed deficit. The current evidence of postoperative rehabilitation after TKA is, however, scares and conflicting, and no studies have shown a lasting effect beyond 3 months postoperatively. PURPOSE The purpose of this study is to investigate if a 6-weeks postoperative rehabilitation intervention is more effective than supervised home training, and furthermore to investigate the cost-effectiveness of the intervention in a societal perspective. MATERIALS & METHODS The study is performed as a randomized clinical trial. In total 140 patients are included in the study. Inclusion criteria are age above 18 years, patients diagnosed as having knee arthrosis, patients receiving primary elective TKA, and patients who are able to and willing transport themselves to the rehabilitation center, which demands ability to walk 50 meter, and climb 10 stair steps. Exclusion criteria are unicompartmental or revision arthroplasty, any neurological disease, knee infection, and substantial pain or functional limitation hindering rehabilitation tested by physiotherapist prior to rehabilitation start. Primary endpoint is 6 months postoperatively and primary outcome measure is change in total score by using the knee specific questionnaire Oxford Knee Score.

Official Title
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Rehabilitation After Fast-track Total Knee Arthroplasty

Conditions
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Knee Arthroplasty

Intervention / Treatment
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* Other: Postoperative rehabilitation after fast-track TKA
* Other: Postoperative rehabilitation after fast-track TKA


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age above 18 years patients diagnosed as having knee arthrosis patients receiving primary elective TKA and patients who are able to and willing transport themselves to the rehabilitation center, which demands ability to walk 50 meter, and climb 10 stair steps Exclusion Criteria: unicompartmental or revision arthroplasty any neurological disease knee infection and substantial pain or functional limitation hindering rehabilitation tested by physiotherapist prior to rehabilitation start

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 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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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Six weeks strength training in teams and patient education<br> | Other: Postoperative rehabilitation after fast-track TKA<br>* Six weeks of strength training combined with patient education<br>* Other names: Patient education;|
| Experimental: Supervised home training with focus on activities<br> | Other: Postoperative rehabilitation after fast-track TKA<br>* Six to eight weeks of supervised home training<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Oxford Knee Score | A disease specific questionnaire, which measures knee pain and function with 12 items. The questionnaire is sum scored with a range from 0 = worse pain and function to 48 = best pain and function | Six months postoperatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| EQ-5D | A generic questionnaire, which measures health-related quality-of-life (HRQOL) with 5 items. The questionnaire is scored with a range from -0.55 = worse HRQOL to 1.00 = best HRQOL | Twelve months postoperatively | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Rehabilitation, Strength training, Long-term effect, Activity and participation after fast-track knee arthroplasty