Rehabilitation After Fast-track Total Knee Arthroplasty

Knee Arthroplasty Clinical Trial

— HOLEST  

Official title:

Rehabilitation After Fast-track Total Knee Arthroplasty

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01329081
• Other study ID #: KL24621
• Status: Withdrawn
• Phase: N/A

Study information

• Verified date: December 2022
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Knee Arthroplasty

Intervention

Other:
• Postoperative rehabilitation after fast-track TKA
Six weeks of strength training combined with patient education
• Postoperative rehabilitation after fast-track TKA
Six to eight weeks of supervised home training

Locations

Country	Name	City	State
Denmark	Orthopedic Research Unit, Hospital Unit West	Holstebro

Sponsors (1)

Lead Sponsor	Collaborator
University of Aarhus

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Six months postoperatively
Secondary	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	Twelve months postoperatively