Clinical trial NCT01329081: Rehabilitation After Fast-track Total Knee Arthroplasty
Official title: Rehabilitation After Fast-track Total Knee Arthroplasty
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Knee Arthroplasty
Keywords: Rehabilitation
Strength training
Long-term effect
Activity and participation after fast-track knee arthroplasty
Lead sponsor: University of Aarhus
Sponsor class: OTHER
First posted: 2011-04-05
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Oxford Knee Score
timeFrame: Six months postoperatively
Secondary outcomes:
measure: EQ-5D
timeFrame: Twelve months postoperatively
Other outcomes:
Locations:
city: Holstebro
country: Denmark
facility: Orthopedic Research Unit, Hospital Unit West
Study officials:
References: