Rehabilitation After Fast-track Total Knee Arthroplasty

NCT01329081 | Withdrawn DMC

• 1 other identifier: KL24621
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Knee Arthroplasty

Keywords

Rehabilitation; Strength training; Long-term effect; Activity and participation after fast-track knee arthroplasty

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• EQ-5D

  Twelve months postoperatively

Study Arms (2)

Six weeks strength training in teams and patient education

EXPERIMENTAL

Other: Postoperative rehabilitation after fast-track TKA

Supervised home training with focus on activities

EXPERIMENTAL

Other: Postoperative rehabilitation after fast-track TKA

Interventions

Postoperative rehabilitation after fast-track TKA OTHER

Six weeks of strength training combined with patient education

Also known as: Rehabilitation, Strength, Patient education

Six weeks strength training in teams and patient education

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• unicompartmental or revision arthroplasty
• any neurological disease
• knee infection and
• substantial pain or functional limitation hindering rehabilitation tested by physiotherapist prior to rehabilitation start

Sponsors & Collaborators

• University of Aarhus: lead

Study Sites (1)

Orthopedic Research Unit, Hospital Unit West

Holstebro, 7500, Denmark

Location

MeSH Terms

Conditions

Motor Activity

Interventions

Rehabilitation; Patient Education as Topic

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services; Health Education; Preventive Health Services

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: April 27, 2010
• First Posted: April 5, 2011
• Last Updated: December 23, 2022

Record last verified: 2022-12

Locations

DK (1)