Rehabilitation After Fast-track Total Knee Arthroplasty (HOLEST)
Recruitment status was Recruiting
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Knee Arthroplasty |
Other: Postoperative rehabilitation after fast-track TKA |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Rehabilitation After Fast-track Total Knee Arthroplasty |
- 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
- 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
| Estimated Enrollment: | 140 |
| Study Start Date: | April 2010 |
| Estimated Study Completion Date: | July 2012 |
| Estimated Primary Completion Date: | December 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Six weeks strength training in teams and patient education |
Other: Postoperative rehabilitation after fast-track TKA
Six weeks of strength training combined with patient education
Other Names:
|
| Experimental: Supervised home training with focus on activities |
Other: Postoperative rehabilitation after fast-track TKA
Six to eight weeks of supervised home training
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| 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:
- unicompartmental or revision arthroplasty
- any neurological disease
- knee infection and
- substantial pain or functional limitation hindering rehabilitation tested by physiotherapist prior to rehabilitation start
Contacts and Locations| Contact: Kristian Larsen, Ph.D. | 99125358 ext 45 | kristian.larsen@svf.au.dk |
| Denmark | |
| Orthopedic Research Unit, Hospital Unit West | Recruiting |
| Holstebro, Denmark, 7500 | |
| Contact: Kristian Larsen, Ph.D. 99125358 ext 45 kristian.larsen@svf.au.dk | |
| Principal Investigator: Kristian Larsen, Ph.D. | |
| Sub-Investigator: Hanne Søe, Physiotherapist | |
| Sub-Investigator: Inger K Madsen, Physiotherapist | |
| Sub-Investigator: Lars Rasmussen, MSc | |
| Sub-Investigator: Torben B Hansen, Ph.D. | |
| Sub-Investigator: Kjeld Søballe, MD, Professor | |
| Sub-Investigator: Henrik Kehlet, Ph.D. | |
More Information
No publications provided
| Responsible Party: | Kristian Larsen, Ph.D., Associate Professor, Principal Investigator, Orthopedic Research Unit, Hospital Unit West, Denmark |
| ClinicalTrials.gov Identifier: | NCT01329081 History of Changes |
| Other Study ID Numbers: | KL24621 |
| Study First Received: | April 27, 2010 |
| Last Updated: | April 4, 2011 |
| Health Authority: | Denmark: The Danish National Committee on Biomedical Research Ethics Denmark: Danish Dataprotection Agency |
Keywords provided by University of Aarhus:
|
Rehabilitation Strength training Long-term effect Activity and participation after fast-track knee arthroplasty |
ClinicalTrials.gov processed this record on June 17, 2013