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Rehabilitation After Fast-track Total Knee Arthroplasty (HOLEST)

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University of Aarhus

Status

Withdrawn

Conditions

Knee Arthroplasty

Treatments

Other: Postoperative rehabilitation after fast-track TKA

Study type

Interventional

Funder types

Other

Identifiers

NCT01329081
KL24621

Details and patient eligibility

About

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.

Sex

All

Ages

18 to 100 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

0 participants in 2 patient groups

Six weeks strength training in teams and patient education
Experimental group
Treatment:
Other: Postoperative rehabilitation after fast-track TKA
Other: Postoperative rehabilitation after fast-track TKA
Supervised home training with focus on activities
Experimental group
Treatment:
Other: Postoperative rehabilitation after fast-track TKA
Other: Postoperative rehabilitation after fast-track TKA

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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