Rehabilitation After Fast-track Total Knee Arthroplasty (HOLEST)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2011 by University of Aarhus.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University of Aarhus
ClinicalTrials.gov Identifier:
NCT01329081
First received: April 27, 2010
Last updated: April 4, 2011
Last verified: April 2011

April 27, 2010
April 4, 2011
April 2010
December 2011   (final data collection date for primary outcome measure)
Oxford Knee Score [ Time Frame: Six months postoperatively ] [ Designated as safety issue: No ]
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
Same as current
Complete list of historical versions of study NCT01329081 on ClinicalTrials.gov Archive Site
EQ-5D [ Time Frame: Twelve months postoperatively ] [ Designated as safety issue: No ]
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
Same as current
Not Provided
Not Provided
 
Rehabilitation After Fast-track Total Knee Arthroplasty
Rehabilitation After Fast-track Total Knee Arthroplasty

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Knee Arthroplasty
  • Other: Postoperative rehabilitation after fast-track TKA
    Six weeks of strength training combined with patient education
    Other Names:
    • Rehabilitation
    • Strength
    • Patient education
  • Other: Postoperative rehabilitation after fast-track TKA
    Six to eight weeks of supervised home training
  • Experimental: Six weeks strength training in teams and patient education
    Intervention: Other: Postoperative rehabilitation after fast-track TKA
  • Experimental: Supervised home training with focus on activities
    Intervention: Other: Postoperative rehabilitation after fast-track TKA
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
140
July 2012
December 2011   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Kristian Larsen, Ph.D. 99125358 ext 45 kristian.larsen@svf.au.dk
Denmark
 
NCT01329081
KL24621
Yes
Kristian Larsen, Ph.D., Associate Professor, Principal Investigator, Orthopedic Research Unit, Hospital Unit West, Denmark
University of Aarhus
Not Provided
Not Provided
University of Aarhus
April 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP