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Rehabilitation After Fast-track Total Knee Arthroplasty

NCT ID: NCT01329081

Last Updated: 2022-12-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

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.

Detailed Description

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Conditions

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Knee Arthroplasty

Keywords

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Rehabilitation Strength training Long-term effect Activity and participation after fast-track knee arthroplasty

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Six weeks strength training in teams and patient education

Group Type EXPERIMENTAL

Postoperative rehabilitation after fast-track TKA

Intervention Type OTHER

Six weeks of strength training combined with patient education

Supervised home training with focus on activities

Group Type EXPERIMENTAL

Postoperative rehabilitation after fast-track TKA

Intervention Type OTHER

Six to eight weeks of supervised home training

Interventions

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Postoperative rehabilitation after fast-track TKA

Six weeks of strength training combined with patient education

Intervention Type OTHER

Postoperative rehabilitation after fast-track TKA

Six to eight weeks of supervised home training

Intervention Type OTHER

Other Intervention Names

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Rehabilitation Strength Patient education

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Aarhus

OTHER

Sponsor Role lead

Responsible Party

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Orthopedic Research Unit, Hospital Unit West, Denmark

Locations

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Orthopedic Research Unit, Hospital Unit West

Holstebro, , Denmark

Site Status

Countries

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Denmark

Other Identifiers

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KL24621

Identifier Type: -

Identifier Source: org_study_id