Clinical trial NCT03750448: Does Rehabilitation After Total Hip and Knee Arthroplasty Work
Official title: Does Rehabilitation After Total Hip and Knee Arthroplasty Work: A Pragmatic, Randomised, Controlled, Superiority Trial (The DRAW1 Trial)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Arthroplasty, Replacement, Knee
Arthroplasty, Replacement, Hip
Telerehabilitation
Rehabilitation
Keywords: Total knee arthroplasty
Total hip arthroplasty
Randomized controlled trial
No intervention
Telerehabilitation
Lead sponsor: Bornholms Regionskommune
Sponsor class: OTHER_GOV
First posted: 2018-11-23
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: Telerehabilitation.

No intervention.

Unsupervised rehabilitation.
Primary purpose: TREATMENT

Brief 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.


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: For THA's: Hip disability and Osteoarthritis Outcome Score (HOOS) subscale: function in daily living (ADL).
timeFrame: Difference between groups at first follow up (6 weeks)
measure: For TKA's: Knee injury and Osteoarthritis Outcome Score (KOOS) subscale: function in daily living (ADL).
timeFrame: Difference between groups at first follow up (6 weeks)
Secondary outcomes:
measure: For THA's: Hip disability and Osteoarthritis Outcome Score (HOOS) subscale: function in daily living (ADL).
timeFrame: Difference between groups at 3 and 12 months follow up.
measure: For TKA's: HKnee injury and Osteoarthritis Outcome Score (KOOS) subscale: function in daily living (ADL).
timeFrame: Difference between groups at 3 and 12 months follow up.
measure: For THA's: Hip disability and Osteoarthritis Outcome Score (HOOS) subscale: symptoms, pain and hip- or knee related quality of life.
timeFrame: Baseline, follow up at 6 weeks, 3 and 12 months.
measure: For TKA's: Knee injury and Osteoarthritis Outcome Score (KOOS) subscales: symptoms, pain and hip- or knee related quality of life.
timeFrame: Baseline, follow up at 6 weeks, 3 and 12 months.
measure: Patient global assessment.
timeFrame: Baseline, follow up at 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: Type of walking assistant devices.
timeFrame: Baseline, follow up at 6 weeks, 3 and 12 months.
measure: Patient satisfaction.: 4-Likert ordinal scale
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: For telerehabilitation group: Exercise adherence
timeFrame: Follow up at 6 weeks.
measure: Exercise adherence.
timeFrame: Follow up at 6 weeks.
Locations:
city: Nexø
country: Denmark
facility: NMC Rehabilitation
state: Bornholm
city: Rønne
country: Denmark
facility: Lunden Rehabilitation
state: Bornholm
city: Rønne
country: Denmark
facility: Sønderbo Rehabilitation
state: Bornholm
Study officials:
affiliation: Physical Medicine and Rehabilitation Research-Copenhagen (PMR-C); Department of Physical and Occupational Therapy; Clinical Research Centre; Department of Orthopaedic Surgery, Hvidovre Hospital, University of Copenhagen, Hvidovre Denmark
name: Thomas Q. Bandholm, Phd.
role: STUDY_DIRECTOR
References:
citation: Mark-Christensen T, Thorborg K, Kallemose T, Bandholm T. Physical rehabilitation versus no physical rehabilitation after total hip and knee arthroplasties: Protocol for a pragmatic, randomized, controlled, superiority trial (The DRAW1 trial). F1000Res. 2021 Feb 25;10:146. doi: 10.12688/f1000research.50814.2. eCollection 2021.