Rehabilitation After Fast-track Total Knee Arthroplasty (HOLEST)

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.

Study Overview

• Status: Withdrawn
• Conditions: Knee Arthroplasty
• Intervention / Treatment: Other: Postoperative rehabilitation after fast-track TKA; Other: Postoperative rehabilitation after fast-track TKA

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Holstebro, Denmark, 7500
    • Orthopedic Research Unit, Hospital Unit West

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 98 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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: Rehabilitation; Patient education; Strength; Other: Postoperative rehabilitation after fast-track TKA; Six to eight weeks of supervised home training
Experimental: Supervised home training with focus on activities	Other: Postoperative rehabilitation after fast-track TKA; Six weeks of strength training combined with patient education; Other Names: Rehabilitation; Patient education; Strength; Other: Postoperative rehabilitation after fast-track TKA; Six to eight weeks of supervised home training

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University of Aarhus

Study record dates

Study Registration Dates

• First Submitted: April 27, 2010
• First Submitted That Met QC Criteria: April 4, 2011
• First Posted (Estimate): April 5, 2011

Study Record Updates

• Last Update Posted (Estimate): December 23, 2022
• Last Update Submitted That Met QC Criteria: December 21, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Keywords: Rehabilitation; Strength training; Long-term effect; Activity and participation after fast-track knee arthroplasty
• Other Study ID Numbers: KL24621