NCT03750448

Does Rehabilitation After Total Hip and Knee Arthroplasty Work

Does Rehabilitation After Total Hip and Knee Arthroplasty Work: A Pragmatic, Randomised, Controlled, Superiority Trial (The DRAW1 Trial)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 168 (actual)
• Sponsor: Bornholms Regionskommune · Other Government
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Background: Total hip- and knee arthroplasty (THA and TKA) is recommended for relieving pain and restoring function for end-stage osteoarthritis, when non-surgical treatment has failed to relieve symptoms. Following THA and TKA post-discharge physical rehabilitation is common practice, but vary significantly regarding content, duration, intensity and mode of delivery. Recent systematic reviews have found home-based rehabilitation to be as good as outpatient rehabilitation in terms of pain and physical function. Additionally, no long-term benefits seem to persist compared to minimal or no intervention following THA or TKA; questioning the true effectiveness of postoperative rehabilitation. However, a true "no intervention" (e.g. no prescribed exercises) has never been investigated following total THA or TKA. The purpose of this present trial is to compare the effectiveness of telerehabilitation, unsupervised rehabilitation and no rehabilitation to enhance recovery following THA and TKA. Methods: This pragmatic, randomised controlled trial will include 168 patients following discharge after THA or TKA. Patients will be randomized into one of the three 6-week interventions: telerehabilitation, unsupervised rehabilitation or no intervention. The trial is designed as a superiority trial to test the hypothesis that rehabilitation (telerehabilitation and unsupervised rehabilitation) is superior to no rehabilitation. The primary outcome will be the difference between intervention groups in terms of the mean score of the Hip disability and Osteoarthritis Outcome Score (HOOS)/ the Knee injury and Osteoarthritis Outcome Score (KOOS)-subscale: function of daily living at first follow-up (end of the 6-week intervention). Additional follow-up are scheduled at 3 and 12 months. Outcome assessors and data analysts are blinded to group allocation. Discussion: As the number of THA and TKA procedures are expected to increase, the need to find effective postoperative rehabilitation strategies are warranted. Knowledge on the effectiveness of the three investigated rehabilitation strategies will help guide the future direction of post-discharge rehabilitation following THA and TKA.

Conditions

• Arthroplasty, Replacement, Knee
• Arthroplasty, Replacement, Hip
• Telerehabilitation
• Rehabilitation

Interventions

Type	Name	Description
OTHER	Telerehabilitation	The telerehabilitation intervention is based on sensor technology, developed by ICURA. The technology consists of motion sensors that can measure and analyse the quantity and quality of the exercises, and a mobile application that can guide the patients with visual response. A unique feature of ICURA trainer allows the physiotherapist to remotely supervise the individual patients exercise adherence and progress. The patients will receive a suitcase with five sensors (to be placed bilaterally on lower legs, thighs and one around the waist), a smartphone to record the exercises and a charging station free of charge during the 6-week intervention. At the end of the intervention the material will be returned at the first follow-up (t1). For more information please visit https://icura.dk.
OTHER	No intervention	Patients allocated to the no intervention group will receive encouragement to stay active and be encouraged to gradually return to activities of daily living. This will be the only exercise-encouragement given to the no-intervention group.
OTHER	Unsupervised rehabilitation	The unsupervised rehabilitation group will receive a written exercise program in order to perform daily exercises at home. The exercise program will be made using Exorlive (for more information about Exorlive please visit https://www.exorlive.com). In addition to the written program, patients will able to use a link provided to see small video-instructions on the internet of each exercise on the program. No feedback or supplementary instructions will be given after the initial face-to-face appointment.

Timeline

• Start date: 2019-01-23
• Primary completion: 2021-01-21
• Completion: 2022-01-12
• First posted: 2018-11-23
• Last updated: 2022-07-20

Locations

3 sites across 1 country: Denmark