Clinical trial NCT04960241: Does Rehabilitation After Total Hip or Knee Arthroplasty Work (DRAW2)
Official title: Physical Rehabilitation Versus No Physical Rehabilitation After Total Hip and Knee Arthroplasties: Protocol for a Pragmatic, Randomized, Controlled, Replication Trial (DRAW2)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Rehabilitation
Telerehabilitation
Arthroplasty, Replacement, Hip
Arthroplasty, Replacement, Knee
Keywords: Rehabilitation
Telerehabilitation
No intervention
Total hip arthroplasty
Total knee arthroplasty
Lead sponsor: Bornholms Regionskommune
Sponsor class: OTHER_GOV
First posted: 2021-07-13
Enrollment: 168
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Homebased telerehabiltation. Homebased rehabilitation. No physical rehabilitation.
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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).

Eligibility criteria: 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.

Primary outcomes:
measure: Function in daily living (ADL).
timeFrame: Difference between groups at first follow up (6 weeks)
Secondary outcomes:
measure: Function in daily living (ADL)
timeFrame: Difference between groups at 3 and 12 months follow up.
measure: Symptoms, pain and quality of life.
timeFrame: Baseline, 6 weeks, 3 and 12 months.
measure: Patient global assessment
timeFrame: Baseline, 6 weeks, 3 and 12 months.
measure: 30-s chair stand test.
timeFrame: Baseline, follow up at 6 weeks, 3 and 12 months
measure: 40 meters walking test.
timeFrame: Baseline, follow up at 6 weeks, 3 and 12 months
measure: Use of analgesics
timeFrame: Baseline, follow up at 6 weeks, 3 and 12 months.
measure: Patient satisfaction
timeFrame: Follow up at 6 weeks.
measure: Time usage (care provider).
timeFrame: Baseline, follow up at 6 weeks, 3 and 12 months
measure: Number of adverse events
timeFrame: Baseline, follow up at 6 weeks, 3 and 12 months
Other outcomes:
measure: Homebased telerehabilitation + homebased rehabilitation group: Exercise adherence
timeFrame: Follow up at 6 weeks
Locations:
city: Nexø
country: Denmark
facility: Genoptræningen, Nørremøllecenteret
state: Bornholm
Study officials:
References: