Does Rehabilitation After Total Hip Or Knee Arthroplasty Work (DRAW2)

Troels Mark Christensen

Status: Completed

Conditions: Arthroplasty, Replacement, Hip; Rehabilitation; Arthroplasty, Replacement, Knee; Telerehabilitation

Treatments: Procedure: No physical rehabilitation; Procedure: Homebased rehabilitation; Procedure: Homebased telerehabilitation

Study type: Interventional

Funder types: Other

Identifiers

NCT04960241

Bornholms Regionskommune

Details and patient eligibility

About

Overall frame: The overall or "parent" DRAW-project is a large-scale project run in Denmark that aims to provide substantial level 1A evidence-data related to the question: Does rehabilitation after total hip and knee replacements work? In the DRAW project, the authors challenge the belief that physical rehabilitation is clinically important - and surely better than "no physical rehabilitation". To challenge this belief thoroughly, the DRAW project holds many individual work packages centered around the same question. These work packages will be conducted in collaboration with municipality rehabilitation centers in Denmark so that specific usual care strategies are reflected in the different trials and local clinical relevance is as well as implementation potential are increased.

Full description

The DRAW2-trial is a pragmatic, randomised controlled trial that aims to replicate the DRAW1-trial findings (clinicaltrials.gov: NCT03750448, trial protocol: https://f1000research.com/articles/10-146). Based on stakeholder input from Municipality Rehabilitation Bornholm, the DRAW1-trial was designed as a superiority trial to test the hypothesis that physical rehabilitation (telerehabilitation and home-based rehabilitation) is superior to no physical rehabilitation in a mixed population of patients after total hip and knee arthroplasty (THA and TKA, respectively). After DRAW1-trial inclusion was completed and the target sample size reached, an opportunity to continue the trial presented because additional funding was obtained. At the same time, Municipality Rehabilitation Bornholm asked for stratified data (THA/TKA) that could help guide their decision concerning a potential purchase of telerehabilitation equipment (more details on stakeholder input can be found in the trial protocol, https://f1000research.com/articles/10-146). To meet this new research objective of stratified analysis for THA and TKA, it was advised from the local ethical committee that a new and almost identical trial was registered, which would allow for a doubling of the sample simple size, so that adequately powered stratified analyses could be made. This new trial is named the DRAW2-trial.

The DRAW2-trial will adhere to the published DRAW1-trial protocol (https://f1000research.com/articles/10-146) and only small logistic modifications to trial procedures have been made. Because some of the DRAW1-trial participants felt overwhelmed by the amount of information they received during the first and only study introduction (usually takes place 5-7 days after surgery), the study introduction in the DRAW2-trial can be divided into two separate consultations a few days apart whenever deemed appropriate by the consulting physiotherapist. The DRAW2 trial will be reported and published independently, including the same outcomes and outcome hierarchy as the DRAW1-trial. As such, it will be an independent replication trial.

Research plan

While the DRAW2-trial will focus on replication of the DRAW-1 trial findings, the opportunity to run a replication trial at the same trial site with little delay between the two trials will also enable us to address the questions outlined below, by subsequent pooling of data from the two trials.

Question 1: Is physical rehabilitation superior to no physical rehabilitation after THA and TKA using two usual care strategies in Denmark (stratified analyses THA vs. TKA by pooling DRAW1 and 2 trial data)?

Question 2: Is home-based rehabilitation as good as home-based telerehabilitation in a mixed population of THA and TKA using two usual care strategies in Denmark (equivalence analysis by pooling DRAW1 and 2 trial data)?

Question 3: Is physical rehabilitation superior to no physical rehabilitation after THA in general (using DRAW1 and 2 THA trial data in an ongoing living systematic review? (https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=203574).

Question 3: Is physical rehabilitation superior to no physical rehabilitation after TKA in general (using DRAW1 and 2 TKA trial data in an ongoing living systematic review? (https://www.crd.york.ac.uk/prospero/display_record.php?ID=CRD42018094785).

Enrollment: 169 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Patients having had primary, unilateral THA or TKA due to osteoarthritis. Patients being referred to receive postoperative rehabilitation at our institution.

Patients being able to speak, read and understand Danish language. Patients aged ≥ 18 years.

Exclusion criteria

Patients not able to comply with exercise instructions. Patients who are discharged to a nursing-home facility or receiving in-home rehabilitation by home care.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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169 participants in 3 patient groups

Homebased telerehabilitation

Active Comparator group

Description:

Patients randomized to this group will receive interactive virtual rehabilitation using a mobile app. The telerehabilitation is based on sensor technology, developed by ICURA. This 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 patient with visual response. A unique feature of ICURA trainer allows the physiotherapist to remotely supervise the individual patients exercise adherence and progress. This technology has already been successfully implemented in several different rehabilitation facilities across Denmark, and, hence, reflects current clinical practice.

Treatment:

Procedure: Homebased telerehabilitation

Homebased rehabilitation

Active Comparator group

Description:

This group will be instructed in similar exercises as patients allocated to telerehabilitation. However, this group will receive a written exercise-program with instructions to perform these exercises at home. The home-based exercise program will be created using exercise templates from Exorlive. Using a link provided in the exercise-program, the patients will be able to see short instruction-videos of the individual exercises.

Treatment:

Procedure: Homebased rehabilitation

No physical rehabilitation

Active Comparator group

Description:

This group of randomised patients will not be given any physical rehabilitation intervention. This means no physical activity or exercise designed and prescribed for restoring normal function or reducing pain cause by disease, injury or surgery. The no intervention group will be encouraged to stay active and continue life as usual, gradually returning to their activities of daily living when they feel ready for it.

Treatment:

Procedure: No physical rehabilitation