Rehabilitation After Fast-track Total Knee Arthroplasty

Not Applicable

Withdrawn

• Conditions: Knee Arthroplasty
• Interventions: Other: Postoperative rehabilitation after fast-track TKA

• Registration Number: NCT01329081
• Lead Sponsor: University of Aarhus

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-04-27
• Study First Submitted QC: 2011-04-04
• Study First Posted: 2011-04-05
• Status Verified: 2022-12
• Last Update Submitted: 2022-12-21
• Last Update Posted: 2022-12-23

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Supervised home training with focus on activities	Postoperative rehabilitation after fast-track TKA	-
Six weeks strength training in teams and patient education	Postoperative rehabilitation after fast-track TKA	-

Primary Outcome Measures

Name	Time	Method
Oxford Knee Score	Six months postoperatively	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

Secondary Outcome Measures

Name	Time	Method
EQ-5D	Twelve months postoperatively	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

Trial Locations

Locations (1)

Orthopedic Research Unit, Hospital Unit West; 🇩🇰 Holstebro, Denmark