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Effectiveness of a home-based telerehabilitation system in patients after total hip arthroplasty: study protocol of a randomized controlled trial.

ABSTRACT: BACKGROUND:The demand for total hip arthroplasty (THA) is quickly rising given the escalating global incidence of hip osteoarthritis, and it is widely accepted that the post-surgery rehabilitation is key to optimize outcomes. The overall objective of this study is to evaluate the effectiveness of a new telerehabilitation solution, ReHub, for the physical function and clinical outcome improvement following THA. The specific aims of this manuscript are to describe the study design, protocol, content of interventions, and primary and secondary outcomes and to discuss the clinical rehabilitation impact of the expected experimental results. METHODS/DESIGN:This prospective, randomized, controlled, parallel-group trial will include 56 patients who had undergone primary THA. Patients are randomized to a control group (standard rehabilitation during the 2-week stay in the rehabilitation clinic followed by 3?weeks of unsupervised home-based rehabilitation) or an experimental group (standard rehabilitation during the 2-week stay in the rehabilitation clinic followed by 3?weeks of home-based ReHub-assisted telerehabilitation). The primary outcome is physical performance assessed through the Timed Up-and-Go (TUG) test. Secondary outcomes include independence level, pain intensity, hip disability, hip range of motion, muscle strength, and patient's perception of clinical improvement. DISCUSSION:Proving the clinical and cost-effectiveness of a home-based telerehabilitation program for physical and muscle function following THA could support its systematic incorporation in post-surgical rehabilitation protocols, which should be tailored to the individual and collective needs. TRIAL REGISTRATION:ClinicalTrial.gov NCT04176315 . Registered on 22 November 2019.

SUBMITTER: Busso C

PROVIDER: S-EPMC7556916 | biostudies-literature | 2020 Oct

REPOSITORIES: biostudies-literature

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Effectiveness of a home-based telerehabilitation system in patients after total hip arthroplasty: study protocol of a randomized controlled trial.

Busso Chiara C Castorina Gabriele G Di Monaco Marco M Rodriguez Daniel D Mahdavi Hadis H Balocco Simone S Trucco Marco M Conti Marco M Castagna Alessandro A Minetto Marco Alessandro MA

Trials 20201014 1

<h4>Background</h4>The demand for total hip arthroplasty (THA) is quickly rising given the escalating global incidence of hip osteoarthritis, and it is widely accepted that the post-surgery rehabilitation is key to optimize outcomes. The overall objective of this study is to evaluate the effectiveness of a new telerehabilitation solution, ReHub, for the physical function and clinical outcome improvement following THA. The specific aims of this manuscript are to describe the study design, protoco ...[more]

PMID: 33054811

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Project description:BackgroundA significant proportion of the overall cost of total hip arthroplasty (THA) results from the inpatient hospital stay following the procedure. Considering the substantial and increasing number of these procedures performed annually, shifting to an outpatient model of care where the patient is discharged home the same day as their surgery represents a potential for significant cost savings. The potential significant impact of an outpatient care model on constrained healthcare budgets and lack of high-quality evidence regarding its effectiveness warrants a rigorous comparative trial. The purpose of this prospective, randomized controlled trial is to evaluate outpatient care pathways for THA. Specifically, our objectives are to compare the rate of serious adverse events and estimate the cost-effectiveness of outpatient compared to standard inpatient THA.MethodsWe will include patients undergoing primary THA whom have an American Society of Anaesthetists status equal to or less than three, live within a 60-min driving distance of the institution and have an adult to accompany them home postoperatively and stay with them overnight. Consenting patients will be randomized to be discharged on the same day as surgery, as outpatients, or as inpatients according to standard of care (minimum of one night in hospital) using a modified Zelen consent model. The primary outcome measure is the incidence of serious adverse events at 30 days postoperative. Participants and their caregivers will complete secondary outcomes measures at each follow-up visit including patient-reported outcome measures and self-reported cost questionnaires.DiscussionThis protocol is the first randomized trial to use blinding to evaluate outpatient THA compared to standard overnight stay and first to prospectively perform a full economic evaluation. It is also the first adequately powered trial to prospectively assess the safety of outpatient THA. Successful completion of this study could have the potential to provide clinical evidence for the role of outpatient THA in current practice.Trial registrationThis study was retrospectively registered on ClinicalTrials.gov ( NCT03026764 ) on March 9th, 2016.

Project description:BackgroundTotal hip arthroplasty (THA) is a very common procedure in orthopedic surgery. In the Netherlands, 25,642 primary THAs were performed in 2013. Postoperative hip dislocation is one of the major complications and has been reported in 0.5 to 10.6 % of patients after primary THA. Several reports regarding the use of an anterolateral surgical approach have shown that a non-restriction or reduced restriction protocol does not increase the dislocation rate. For the posterolateral surgical approach it has been suggested that patient restrictions might be unnecessary but the amount of available literature is scarce. As such, randomized controlled trials aimed at investigating restrictions following THA using a posterior approach are strongly recommended. The aim of this prospective randomized controlled trial is to investigate the non-inferiority hypothesis concerning the early dislocation rate after THA in patients with and without the use of a reduced restriction protocol.Methods/designAfter providing informed consent a group of 456 patients with symptomatic coxarthrosis will be randomized to receive a THA either with care as usual, i.e. receiving postoperative restrictions including the advice to sleep in a supine position for the first 8 weeks postoperatively, or reduced restrictions with no recommendations regarding the position during sleeping. Primary outcome measure will be the percentage of early dislocations within the first 8 weeks after THA. Secondary outcome measures will be patient satisfaction, time to functional recovery, quality of sleep and patient's self-reported compliance with postoperative instructions.DiscussionTo our knowledge this will be the first randomized controlled trial that compares a reduced restriction protocol with a restricted protocol following THA using a posterolateral surgical approach. Our hypothesis is that a reduced restriction protocol following THA with use of a posterolateral surgical approach has no influence on the early dislocation rate compared to a restricted protocol. Instead, embracing a reduced restriction protocol might even contribute to a higher quality of sleep, thereby facilitating a faster uptake and return to daily functions in patients after THA.Trial registrationClinicalTrials.gov NCT02107248 , registration date 3 April 2014.

Project description:BackgroundTotal hip arthroplasty (THA) is very effective in alleviating pain, but functional deficits persist up to a year following surgery. Regardless of standard physiotherapy programs, significant additional muscular atrophy and weakness occur. Deficits in strength have serious adverse consequences for these patients with respect to physical function, the maintenance of independence, and the requirement for revision surgery. Progressive resistance training in rehabilitation following THA has been shown to significantly enhance muscle strength and function. The fundamental principle is to progressively overload the exercised muscle as it becomes stronger. Different strength training protocols have been used at different times in the postoperative phase, in group or individual practices, with major differences being in center-based and home-based programs with or without supervision. The primary objective of our study is to evaluate whether an early postoperative home-based strength training protocol can improve patient functional outcomes at 3 months and 1 year following surgery. Secondary objectives are the feasibility of the presented protocol for all elective THA patients and its safety.Methods/designThis study is a prospective multicenter randomized clinical trial to be conducted in the orthopedic departments of two Slovenian hospitals. In each hospital, 124 patients aged 60 or older with unilateral osteoarthritis, an ASA score between 1 and 3, a signed informed consent form, and no terminal illness disabling rehabilitation participation will be randomly assigned to the intervention or control group. THA with an anterior approach will be performed. All patients will receive current standard physiotherapy during hospitalization. Patients in the intervention group will also learn strength and sensory-motor training exercises. Upon discharge, all will receive USB drives with exercise videos, written exercise instructions, and a training diary. Physiotherapists will perform the assessments (physical tests and the maximal voluntary isometric contraction assessment), and patients will fill out outcome assessment questionnaires (the Harris Hip Score and 36-Item Short Form Health Survey) at baseline and 1, 3, and 12 months after surgery.DiscussionThe main purpose of our study is to design a new standardized rehabilitation protocol with videos that will be effective, safe, and accessible to all Slovenian THA patients.Trial registrationClinicalTrials.gov NCT04061993 . Registered on 07 November 2019. Protocol ID: PRT_PhD. Version 1.

Project description:BACKGROUND:Telerehabilitation can contribute to the maintenance of successful rehabilitation regardless of location and time. The aim of this study was to investigate a specific three-month interactive telerehabilitation routine regarding its effectiveness in assisting patients with physical functionality and with returning to work compared to typical aftercare. OBJECTIVE:The aim of the study was to investigate a specific three-month interactive telerehabilitation with regard to effectiveness in functioning and return to work compared to usual aftercare. METHODS:From August 2016 to December 2017, 111 patients (mean 54.9 years old; SD 6.8; 54.3% female) with hip or knee replacement were enrolled in the randomized controlled trial. At discharge from inpatient rehabilitation and after three months, their distance in the 6-minute walk test was assessed as the primary endpoint. Other functional parameters, including health related quality of life, pain, and time to return to work, were secondary endpoints. RESULTS:Patients in the intervention group performed telerehabilitation for an average of 55.0 minutes (SD 9.2) per week. Adherence was high, at over 75%, until the 7th week of the three-month intervention phase. Almost all the patients and therapists used the communication options. Both the intervention group (average difference 88.3 m; SD 57.7; P=.95) and the control group (average difference 79.6 m; SD 48.7; P=.95) increased their distance in the 6-minute-walk-test. Improvements in other functional parameters, as well as in quality of life and pain, were achieved in both groups. The higher proportion of working patients in the intervention group (64.6%; P=.01) versus the control group (46.2%) is of note. CONCLUSIONS:The effect of the investigated telerehabilitation therapy in patients following knee or hip replacement was equivalent to the usual aftercare in terms of functional testing, quality of life, and pain. Since a significantly higher return-to-work rate could be achieved, this therapy might be a promising supplement to established aftercare. TRIAL REGISTRATION:German Clinical Trials Register DRKS00010009; https://www.drks.de/drks_web/navigate.do? navigationId=trial.HTML&TRIAL_ID=DRKS00010009.

Project description:BackgroundRobotic-arm assisted surgery aims to reduce manual errors and improve the accuracy of implant positioning during total hip arthroplasty. The objective of this study is to compare the accuracy of implant positioning, restoration of hip biomechanics, patient satisfaction, functional outcomes, implant survivorship, cost-effectiveness, and complications in conventional manual total hip arthroplasty (CO THA) versus robotic-arm assisted total hip arthroplasty (RO THA). Preoperative pelvic computerised tomography (CT) scans will be used to create patient-specific, virtual, three-dimensional reconstructions for surgical planning in both treatment groups.Methods and analysisThis prospective randomised controlled trial will include 60 patients with symptomatic hip osteoarthritis undergoing primary THA. Following informed consent, patients will be randomised to CO THA (control group) or RO THA (investigation group) at a ratio of 1:1 using an online random number generator. Observers will review patients at regular intervals for 2 years after surgery to record predefined study outcomes relating to the accuracy of implant positioning, hip biomechanics, postoperative rehabilitation, clinical progress, functional outcomes, cost-effectiveness, and complications. Primary and secondary objectives will be used to quantify and draw inferences on differences in the efficacy of treatment between the two groups. Intention-to-treat and per-protocol population analysis will be undertaken. Intention to treat relates to the allocated treatment (CO THA or RO THA), and per-protocol refers to the actual treatment received by the patient. The following statistical methods will be employed to analyse the data: descriptive statistics, independent t test, paired t test, analysis of variance, Fisher exact test, chi-square test, and graphical displays. Ethical approval was obtained from the London-Bromley Research Ethics Committee, UK. The study is sponsored by University College London, UK.DiscussionThis study compares a comprehensive and robust range of clinical, functional, and radiological outcomes in CT-planned CO THA versus CT-planned RO THA. The findings of this study will enable an improved understanding of the differences in CO THA versus RO THA with respect to patient satisfaction, functional outcomes, implant survivorship, cost-effectiveness, and complications.Trial registrationClinicalTrials.gov NCT04095845 . Registered on 19 September 2019.

Project description:BackgroundSupercapsular percutaneously-assisted total hip (SuperPath) arthroplasty has been proposed to be minimally invasive and tissue sparing, with possible superior postoperative outcomes compared with conventional approaches for total hip arthroplasty (THA). However, previous studies have underlined the shortcomings of conventional THA approaches, including higher dislocation, more blood loss, longer incisions, more tissue damage, and delayed postoperative rehabilitation. In the present study, we compared the short-term outcomes of unilateral THA with those of SuperPath and the mini-incision posterolateral approach (PLA) for hip osteoarthritis (OA).MethodsPatients with unilateral hip OA were prospectively recruited and underwent either SuperPath (SuperPath group) or mini-incision PLA THA (PLA group). Perioperative status [operative time, incision length, intraoperative blood loss, soft tissue damage, and length of hospital stay (LOS)], and postoperative function outcomes, including range of motion (ROM), pain visual analog scale (VAS), and Harris Hip Score (HHS), were evaluated and compared between the groups at scheduled time points within 12 months postoperatively.ResultsCompared with the PLA group, the SuperPath group yielded a significantly shorter incision length (7.83 vs. 12.45 cm, P<0.001), longer operative time (102.72 vs. 66.22 min, P<0.001), more blood loss (1,007.38 vs. 844.55 mL, P=0.005), and more soft tissue damage (creatine kinase: 1,056.05 vs. 821.50 U/L, P=0.006) on postoperative day 3. The SuperPath group also showed deficient acetabular cup positioning (abduction angle: 36.94° vs. 42.66°, P=0.004) and a greater decrease in ROM (flexion: 107.66° vs. 114.44°, P=0.004; 109.83° vs. 116.11°, P=0.002; 111.66° vs. 118.88°, P<0.001) on postoperative days 1, 3, and 14, as well as severe early-term pain symptoms (pain VAS on postoperative day 3: 7.05 vs. 6.55, P=0.041). However, the LOS, C-reactive protein levels, erythrocyte sedimentation rate (within 2 weeks postoperatively), and HHS were comparable between the groups during the 12 months postoperatively.ConclusionsSuperPath may be a promising, minimally invasive technique for the treatment of OA in the future. Further investigation is necessary to evidence the possible superiority of SuperPath over other conventional mini-incision THA approaches.

Project description:BackgroundTotal hip arthroplasty is considered an efficacious procedure for relieving pain and disability, but despite that objectively measured physical activity level remains unchanged compared to pre-surgery and is still considerably lower than that of a healthy age- and sex-matched population 6-12 months post-surgery. Since there is a graded relationship between physical activity level and functional performance, increasing physical activity may enhance the outcome of the procedure. This study aims to investigate whether promotion and support of physical activity initiated 3 months after total hip arthroplasty complementary to usual rehabilitation care can increase objective measured physical activity 6 months post-surgery.MethodsThe trial is designed as a pragmatic, parallel group, two-arm, assessor-blinded, superiority, randomized (1:1), controlled trial with post intervention follow-up 6 and 12 months after total hip arthroplasty. Home-dwelling, independent, and self-reliant patients with hip osteoarthritis are provisionally enrolled prior to surgery and re-screened about 2-3 months post-surgery to confirm eligibility. Baseline assessment is conducted 3 months post-surgery. Subsequently, patients (n=200) are randomized to either a 3-month, multimodal physical activity promotion/education intervention or control (no further attention). The intervention consists of face-to-face and telephone counselling, patient education material, pedometer, and step-counting journal. The primary outcome is objectively measured physical activity, specifically the proportion of patients that complete on average ≥8000 steps per day 6 months post-surgery. Secondary outcomes include core outcomes (i.e., physical function, pain, and patient global assessment) and health-related quality of life. Furthermore, we will explore the effect of the intervention on self-efficacy and outcome expectations (i.e., tertiary outcomes).DiscussionBy investigating the effectiveness of a pedometer-driven, face-to-face, and telephone-assisted counselling, behavior change intervention in complementary to usual rehabilitation, we hope to deliver applicable and generalizable knowledge to support physical activity after total hip arthroplasty and potentially enhance the outcome of the procedure.Trial registrationwww.Clinicaltrialsgov NCT04471532 . Registered on July 15, 2020.

Dataset Information

Effectiveness of a home-based telerehabilitation system in patients after total hip arthroplasty: study protocol of a randomized controlled trial.

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Effectiveness of a home-based telerehabilitation system in patients after total hip arthroplasty: study protocol of a randomized controlled trial.

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