Does Rehabilitation After Total Hip and Knee Arthroplasty Work

NCT03750448 | Completed

• 1 other identifier: 56929866
• Study Type: interventional
• Target: 168
• Locations: 1 country
• Sites: 3

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.

Conditions

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

Keywords

Total knee arthroplasty; Total hip arthroplasty; Randomized controlled trial; No intervention; Telerehabilitation

Outcome Measures

Primary Outcomes (2)

• For THA's: Hip disability and Osteoarthritis Outcome Score (HOOS) subscale: function in daily living (ADL).

  This subscale consists of 17 questions related to the patient's function in activities of daily living such as "descending stairs", "standing" and "getting in/out of car". The subscale is scored by the degree of difficulty the patient experiences in the last week on a 5-point Likert scale (none, mild, moderate, severe, and extreme), and calculated to a score ranging from 0 (worst/extreme difficulties) to 100 (best/ no problems). The total questionnaire takes about 10 minutes to complete. At least 50% of the questionnaire items are required to be answered to permit calculation of a mean score.

  Difference between groups at first follow up (6 weeks)

• For TKA's: Knee injury and Osteoarthritis Outcome Score (KOOS) subscale: function in daily living (ADL).

  This subscale consists of 17 questions related to the patient's function in activities of daily living such as "descending stairs", "standing" and "getting in/out of car". The subscale is scored by the degree of difficulty the patient experiences in the last week on a 5-point Likert scale (none, mild, moderate, severe, and extreme), and calculated to a score ranging from 0 (worst/extreme difficulties) to 100 (best/ no problems). The total questionnaire takes about 10 minutes to complete. At least 50% of the questionnaire items are required to be answered to permit calculation of a mean score.

  Difference between groups at first follow up (6 weeks)

Secondary Outcomes (12)

• For THA's: Hip disability and Osteoarthritis Outcome Score (HOOS) subscale: function in daily living (ADL).

  Difference between groups at 3 and 12 months follow up.

• For TKA's: HKnee injury and Osteoarthritis Outcome Score (KOOS) subscale: function in daily living (ADL).

  Difference between groups at 3 and 12 months follow up.

• For THA's: Hip disability and Osteoarthritis Outcome Score (HOOS) subscale: symptoms, pain and hip- or knee related quality of life.

  Baseline, follow up at 6 weeks, 3 and 12 months.

• For TKA's: Knee injury and Osteoarthritis Outcome Score (KOOS) subscales: symptoms, pain and hip- or knee related quality of life.

  Baseline, follow up at 6 weeks, 3 and 12 months.

• Patient global assessment.

  Baseline, follow up at 6 weeks, 3 and 12 months.

Other Outcomes (2)

• For telerehabilitation group: Exercise adherence

  Follow up at 6 weeks.

• Exercise adherence.

  Follow up at 6 weeks.

Study Arms (3)

Telerehabilitation

ACTIVE COMPARATOR

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.

Other: Telerehabilitation

No intervention

ACTIVE COMPARATOR

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.

Other: No intervention

Unsupervised rehabilitation

ACTIVE COMPARATOR

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.

Other: Unsupervised rehabilitation

Interventions

Telerehabilitation OTHER

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.

Telerehabilitation

No intervention OTHER

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.

No intervention

Unsupervised rehabilitation OTHER

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.

Unsupervised rehabilitation

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bornholms Regionskommune: lead

Study Sites (3)

NMC Rehabilitation

Nexø, Bornholm, 3730, Denmark

Location

Lunden Rehabilitation

Rønne, Bornholm, 3700, Denmark

Location

Sønderbo Rehabilitation

Rønne, Bornholm, 3700, Denmark

Location

Related Publications (2)

• Mark-Christensen T, Thorborg K, Kallemose T, Bandholm T. Clinical benefit of physical rehabilitation after total hip and knee arthroplasty: A pragmatic, randomized, controlled trial (The DRAW1 trial). Osteoarthr Cartil Open. 2024 Oct 16;6(4):100530. doi: 10.1016/j.ocarto.2024.100530. eCollection 2024 Dec.

  PMID: 39507936 DERIVED

• 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.

  PMID: 34316356 DERIVED

MeSH Terms

Interventions

Telerehabilitation

Intervention Hierarchy (Ancestors)

Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services; Telemedicine; Delivery of Health Care; Patient Care Management; Health Services Administration

Study Officials

• Thomas Q. Bandholm, Phd.

  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

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: A physiotherapist will assess the outcomes at baseline after which the patients are randomized. The same physiotherapist will then deliver the allocated intervention and no longer assess outcomes for this patient. A different physiotherapist, who is blinded to treatment allocation, will assess outcomes at the follow-up visits in this patient. At all follow-up visits, patients will be asked not to disclose any information regarding group allocation, and the physiotherapists will be instructed not to ask questions regarding group allocation. The patients are blinded to the trial hypothesis in order to prevent ascertainment bias. The principal investigator is not an outcome assessor and will not be blinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Model Details: Telerehabilitation. No intervention. Unsupervised rehabilitation.

Study Record Dates

• First Submitted: November 14, 2018
• First Posted: November 23, 2018
• Study Start: January 23, 2019
• Primary Completion: January 21, 2021
• Study Completion: January 12, 2022
• Last Updated: July 20, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

DK (3)