Does Rehabilitation After Total Hip and Knee Arthroplasty Work

Rehabilitation Clinical Trial

— DRAW1  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03750448
• Other study ID #: 56929866
• Status: Completed
• Phase: N/A
• Start date: January 23, 2019
• Est. completion date: January 12, 2022

Study information

• Verified date: July 2022
• Source: Bornholms Regionskommune
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 168
• Est. completion date: January 12, 2022
• Est. primary completion date: January 21, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

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.
• 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.
• 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.

Locations

Country	Name	City	State
Denmark	NMC Rehabilitation	Nexø	Bornholm
Denmark	Lunden Rehabilitation	Rønne	Bornholm
Denmark	Sønderbo Rehabilitation	Rønne	Bornholm

Sponsors (1)

Lead Sponsor	Collaborator
Bornholms Regionskommune

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	For telerehabilitation group: Exercise adherence	Exercise adherence will be measured as a percentage (0-100), where 0 % indicates total non-adherence and 100 % indicates total adherence to the exercise prescription. Exercise adherence is objectively recorded in the telerehabilitation group and can be extracted from the device used by the patients.	Follow up at 6 weeks.
Other	Exercise adherence.	Exercise adherence will be measured as a self-reported percentage (0-100), where 0 % indicates total non-adherence and 100 % indicates total adherence to the exercise prescription. The patients will be asked: "What percentage of the prescribed 42 exercise sessions (one exercise session per day for 6 weeks; corresponding to 100 %) have you completed the past 6 weeks?". The scale will be illustrated with a 0-100mm visual rating scale.	Follow up at 6 weeks.
Primary	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)
Primary	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	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 3 and 12 months follow up.
Secondary	For TKA's: HKnee 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 3 and 12 months follow up.
Secondary	For THA's: Hip disability and Osteoarthritis Outcome Score (HOOS) subscale: symptoms, pain and hip- or knee related quality of life.	These subscales are scored by the degree of difficulty the patient has experienced in the last week on a 5-point Likert scale. Each subscale provides a score, which can be calculated to a total score ranging from 0 (worst/extreme difficulties) to 100 (best/ no problems). At least 50% of the questionnaire items in each subscale are required to be answered to permit calculation of a mean score.	Baseline, follow up at 6 weeks, 3 and 12 months.
Secondary	For TKA's: Knee injury and Osteoarthritis Outcome Score (KOOS) subscales: symptoms, pain and hip- or knee related quality of life.	These subscales are scored by the degree of difficulty the patient has experienced in the last week on a 5-point Likert scale. Each subscale provides a score, which can be calculated to a total score ranging from 0 (worst/extreme difficulties) to 100 (best/ no problems). At least 50% of the questionnaire items in each subscale are required to be answered to permit calculation of a mean score.	Baseline, follow up at 6 weeks, 3 and 12 months.
Secondary	Patient global assessment.	At baseline the patient's perception of his or her overall functional ability will be assessed using a single numeric rating scale, as recommended by OARSI. The patient will be asked a single question: "How would you rate your current level of function during your usual activities of daily living?" During follow-up assessment patients will be asked the same question as at baseline. Their answer will be rated on a 0-100 visual rating scale with end-points anchored as "Inability to perform any daily activities" (0) and "No problem with any daily activity" (100)	Baseline, follow up at 6 weeks, 3 and 12 months.
Secondary	30-s chair stand test.	Performance-based assessment will be performed using the 30-s chair-stand test, which represent the sit-to-stand activity. The test counts the number of sit-to-stand repetitions the patient can perform in 30 seconds. The straight-back chairs used for testing during all outcome assessments will be of the same model, same height (approximately 43 cm), and will be placed against a wall. Any other adaptations (i.e. the use of armrests or assistive devices) will be reported. To assure understanding, two slow-paced repetitions will be practiced before the test initiates. The 30-s chair stand test has proven good reliability to measure functional performance following THA and TKA.	Baseline, follow up at 6 weeks, 3 and 12 months.
Secondary	40 meters walking test.	This performance-based assessment measures short distance walking activity. The patient will be instructed to walk as quickly as safely as possible to a mark 10 meters away, return and repeat for a total distance of 40 meters. Each walk of 10 meters (excluding the turn time) is recorded and expressed as speed m/s by dividing distance by time in seconds. A practice walk up and back will be performed to assure understanding. Any assistive devices used will be recorded.	Baseline, follow up at 6 weeks, 3 and 12 months.
Secondary	Use of analgesics.	The use of analgesics will recorded at baseline and at all follow-up assessments, using a nominal scale (yes/no) regarding the daily consumption of opioids, non-steroid-anti inflammatorily drug (NSAID) and paracetamol. If the patient were not aware of his or hers use of analgesics, a medical record will obtained to assess the use of analgesics.	Baseline, follow up at 6 weeks, 3 and 12 months.
Secondary	Type of walking assistant devices.	The type (e.g. elbow crutches, walker) will be recorded. The need for walking assistant devices will be assessed by what the patient use during normal activities of daily living.	Baseline, follow up at 6 weeks, 3 and 12 months.
Secondary	Patient satisfaction.: 4-Likert ordinal scale	Patients will be asked to answer four questions to indicate their level of satisfaction. The answers will be based on a 4-Likert ordinal scale with the categories: very satisfied (100 points), somewhat satisfied (75 points), somewhat dissatisfied (50 points), and very dissatisfied (25 points). The score is the unweighted mean of the combined scores. The four questions are: "How satisfied are you with the results of your surgery and rehabilitation?", "How satisfied are you with your surgery and rehabilitation for improving your pain?", "How satisfied are you with the results of your surgery and rehabilitation for improving your ability to do home or yard work?" and "How satisfied are you with the results of surgery and rehabilitation for improving your ability to do recreational activities?". The questions are modified from the Self-Administered Patient Satisfaction Scale for Primary Hip and Knee Arthroplasty.	Follow up at 6 weeks.
Secondary	Time usage (care provider).	Analysis of the economical resources required for each of the three rehabilitation strategies. The principal investigator intend to use this data in a later cost-analysis.	Baseline, follow up at 6 weeks, 3 and 12 months.
Secondary	Number of adverse events.	Number and nature of adverse events during enrolment of the trial will be recorded, regardless of the relation to the trial.	Baseline, follow up at 6 weeks, 3 and 12 months.