CClinicalTrials.gg
WithdrawnNCT01329081HOLESTUpdated Dec 23, 2022

Rehabilitation After Fast-track Total Knee Arthroplasty

An interventional study of Postoperative rehabilitation after fast-track TKA and Postoperative rehabilitation after fast-track TKA in Knee Arthroplasty, sponsored by University of Aarhus. Withdrawn at 1 site in Denmark. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2022-12-23.

Sponsored by University of Aarhus · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
0
Allocation
Randomized
Ages
18 Years to 100 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Knee Arthroplasty

Keywords

  • Rehabilitation
  • Strength training
  • Long-term effect
  • Activity and participation after fast-track knee arthroplasty
03

In context

Lead sponsor

University of Aarhus is the lead sponsor of 1,274 studies on the registry; 183 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 100 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
0 participants (actual)

Study arms

  • Experimental
    Six weeks strength training in teams and patient education

    Other: Postoperative rehabilitation after fast-track TKA

  • Experimental
    Supervised home training with focus on activities

    Other: Postoperative rehabilitation after fast-track TKA

Interventions

  • OtherPostoperative rehabilitation after fast-track TKA

    Six weeks of strength training combined with patient education

    Also known as: Rehabilitation, Strength, Patient education

  • OtherPostoperative rehabilitation after fast-track TKA

    Six to eight weeks of supervised home training

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: Six months postoperatively

Secondary outcomes

  1. 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

    Time frame: Twelve months postoperatively

07

Study locations

1 site
  • Orthopedic Research Unit, Hospital Unit West
    Holstebro, 7500, Denmark
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 23, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01329081
Lead sponsor
University of Aarhus
First posted
Apr 5, 2011
Last update
Dec 23, 2022

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is withdrawn, as verified in Dec 2022. You cannot join it, but the record below documents what was studied.

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