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Hospital Inpatient versus HOme-based rehabilitation after knee arthroplasty (The HIHO study): study protocol for a randomized controlled trial.

ABSTRACT: Formal rehabilitation programs are often assumed to be required after total knee arthroplasty to optimize patient recovery. Inpatient rehabilitation is a costly rehabilitation option after total knee arthroplasty and, in Australia, is utilized most frequently for privately insured patients. With the exception of comparisons with domiciliary services, no randomized trial has compared inpatient rehabilitation to any outpatient based program. The Hospital Inpatient versus HOme (HIHO) study primarily aims to determine whether 10 days of post-acute inpatient rehabilitation followed by a hybrid home program provides superior recovery of functional mobility on the 6-minute walk test (6MWT) compared to a hybrid home program alone following total knee arthroplasty. Secondarily, the trial aims to determine whether inpatient rehabilitation yields superior recovery in patient-reported function.This is a two-arm parallel randomized controlled trial (RCT), with a third, non-randomized, observational group. One hundred and forty eligible, consenting participants who have undergone a primary total knee arthroplasty at a high-volume joint replacement center will be randomly allocated when cleared for discharge from acute care to either 10 days of inpatient rehabilitation followed by usual care (a 6-week hybrid home program) or to usual care. Seventy participants in each group (140 in total) will provide 80% power at a significance level of 5% to detect an increase in walking capacity from 400 m to 460 m between the Home and Inpatient groups, respectively, in the 6MWT at 6 months post-surgery, assuming a SD of 120 m and a drop-out rate of <10%.The outcome assessor will assess participants at 10, 26 and 52 weeks post-operatively, and will remain blind to group allocation for the duration of the study, as will the statistician. Participant preference for rehabilitation mode stated prior to randomization will be accounted for in the analysis together with any baseline differences in potentially confounding characteristics as required.The HIHO Trial will be the first RCT to investigate the efficacy of inpatient rehabilitation compared to any outpatient alternative following total knee arthroplasty.U.S. National Institutes of Health Clinical Trials Registry (http://clinicaltrials.gov) ref: NCT01583153.

SUBMITTER: Buhagiar MA

PROVIDER: S-EPMC3878550 | biostudies-literature | 2013 Dec

REPOSITORIES: biostudies-literature

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Hospital Inpatient versus HOme-based rehabilitation after knee arthroplasty (The HIHO study): study protocol for a randomized controlled trial.

Buhagiar Mark A MA Naylor Justine M JM Harris Ian A IA Xuan Wei W Kohler Friedbert F Wright Rachael J RJ Fortunato Renee R

Trials 20131217

<h4>Background</h4>Formal rehabilitation programs are often assumed to be required after total knee arthroplasty to optimize patient recovery. Inpatient rehabilitation is a costly rehabilitation option after total knee arthroplasty and, in Australia, is utilized most frequently for privately insured patients. With the exception of comparisons with domiciliary services, no randomized trial has compared inpatient rehabilitation to any outpatient based program. The Hospital Inpatient versus HOme (H ...[more]

PMID: 24341348

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Project description:BackgroundThe global increase in total hip or knee arthroplasty has led to concern about the provision of postoperative rehabilitation. Telerehabilitation may be a strategy to meet the patients' requirements for rehabilitation after arthroplasty. This study aims to investigate the effectiveness of a telerehabilitation programme delivered via the mobile application WeChat in patients after total hip or knee arthroplasty on the following outcomes: self-efficacy, physical function, pain, depression, anxiety and health-related quality of life.MethodsThis is a single-centre, single-blinded, parallel-group, superiority randomised controlled trial conducted in Shanghai, China. Eighty-four eligible participants who undergo primary total hip or knee arthroplasty will be recruited preoperatively in a university teaching hospital and randomly assigned to the experimental or control group with their informed consent. Once discharged, the control group (n = 42) will receive the usual care provided by the hospital. The experimental group (n = 42) will receive usual care and a 6-week mobile application rehabilitation programme that consists of physical exercises and techniques for enhancing participants' self-efficacy for rehabilitation. Baseline assessments will be conducted on the day before hospital discharge, and outcome assessments will be conducted 6 and 10 weeks postoperatively. The primary outcomes are changes in self-efficacy and physical function 6 weeks postoperatively, and the secondary outcomes include pain, depression, anxiety and health-related quality of life. The approach of a generalised estimating equation will be used to analyse the effect of the intervention on outcomes at a significance level of 0.05.DiscussionThis study is the first of its kind conducted in China to incorporate self-efficacy and learning theories as a framework to guide the development of a mobile application rehabilitation programme after arthroplasty. This study will contribute to the knowledge about the effectiveness of mobile application-based rehabilitation among patients after total hip or knee arthroplasty. If the findings are positive, they will support the implementation of mobile application-based rehabilitation in practice, which may potentially increase the accessibility of rehabilitation services as well as patient adherence to rehabilitation.Trial registrationAustralian New Zealand Clinical Trials Registry ACTRN12621000867897 . Retrospectively registered on July 6, 2021.

Project description:BackgroundGeriatric rehabilitation aims to maintain the functional reserves of older adults in order to optimize social participation and prevent disability. After discharge from inpatient geriatric rehabilitation, patients are at high risk for decreased physical capacity, increased vulnerability, and limitations in mobility. As a result, ageing in place becomes uncertain for a plethora of patients after discharge from geriatric rehabilitation and effective strategies to prevent physical decline are required. Collaboration between different health-care providers is essential to improve continuity of care after discharge from inpatient geriatric rehabilitation. The aim of this study is to evaluate the effectiveness of a multi-professional home-based intervention program (GeRas) to improve functional capacity and social participation in older persons after discharge from inpatient geriatric rehabilitation.MethodsThe study is a multicenter, three-arm, randomized controlled trial with a three-month intervention period. Two hundred and seventy community-dwelling older people receiving inpatient geriatric rehabilitation will be randomized with a 1:1:1 ratio to one of the parallel intervention groups (conventional IG or tablet IG) or the control group (CG). The participants of both IGs will receive a home-based physical exercise program supervised by physical therapists, a nutritional recommendation by a physician, and social counseling by social workers of the health insurance company. The collaboration between the health-care providers and management of participants will be realized within a cloud environment based on a telemedicine platform and supported by multi-professional case conferences. The CG will receive usual care, two short handouts on general health-related topics, and facultative lifestyle counseling with general recommendations for a healthy diet and active ageing. The primary outcomes will be the physical capacity measured by the Short Physical Performance Battery and social participation assessed by the modified Reintegration to Normal Living Index, three months after discharge.DiscussionThe GeRas program is designed to improve the collaboration between health-care providers in the transition from inpatient geriatric rehabilitation to outpatient settings. Compared to usual care, it is expected to improve physical capacity and participation in geriatric patients after discharge from inpatient geriatric rehabilitation.Trial registrationGerman Clinical Trials Register (DRKS00029559). Registered on October 05, 2022.

Project description:BACKGROUND:Physical rehabilitation is recommended after total knee arthroplasty (TKA). With the expected increase in TKA over the next few decades, it is important to find new ways of delivering cost-effective interventions. Technological interventions have been developed with this intent, but only preliminary evidence exists regarding their validity, with short follow-up times. OBJECTIVE:This study aimed to present the follow-up results of a feasibility study comparing two different home-based programs after TKA: conventional face-to-face sessions and a digital intervention performed through the use of an artificial intelligence-powered biofeedback system under remote clinical monitoring. METHODS:The digital intervention uses a motion tracker allowing 3D movement quantification, a mobile app and a Web portal. This study presents the results of the previous single-center, prospective, parallel-group, feasibility study including an 8-week active treatment stage and further assessments at 3 and 6 months post-TKA. Primary outcome was the Timed Up and Go score, and secondary outcomes were the Knee Osteoarthritis Outcome Scale (KOOS) score and knee range of motion. RESULTS:A total of 59 patients completed the study (30 in the digital intervention group and 29 in the conventional rehabilitation group) and follow-up assessments. During the active treatment stage, patients in the digital intervention group demonstrated high engagement and satisfaction levels, with an 82% retention rate. Both groups attained clinically relevant improvements from baseline to 6 months post-TKA. At the end of the 8-week program, clinical outcomes were superior in the digital intervention group. At the 3- and 6-month assessments, the outcomes remained superior for the Timed Up and Go score (P<.001) and all KOOS subscale scores (at 3 months, P<.001 overall; at 6 months, KOOS Symptoms: P=.006, Pain: P=.002, Activities of Daily Living: P=.001, Sports: P=.003, and Quality of Life: P=.001). There was progressive convergence between both groups in terms of the knee range of motion, which remained higher for standing flexion in the digital intervention group than the conventional group at 6 months (P=.01). For the primary outcome, at 6 months, the median difference between groups was 4.87 seconds (95% CI 1.85-7.47), in favor of the digital intervention group. CONCLUSIONS:The present study demonstrates that this novel digital intervention for independent home-based rehabilitation after TKA is feasible, engaging, and capable of maximizing clinical outcomes in comparison to conventional rehabilitation in the short and medium term; in addition, this intervention is far less demanding in terms of human resources. TRIAL REGISTRATION:ClinicalTrials.gov NCT03047252; https://clinicaltrials.gov/ct2/show/NCT03047252.

Project description:BackgroundThere remains a paucity of clinical studies assessing how any differences in accuracy of implant positioning between robotic-arm assisted unicompartmental knee arthroplasty (RO UKA) and conventional jig-based unicompartmental knee arthroplasty (CO UKA) translate to patient satisfaction, functional outcomes, and implant survivorship. The objectives of this study are to compare accuracy of implant positioning, limb alignment, patient satisfaction, functional outcomes, implant survivorship, cost-effectiveness, and complications in CO UKA versus RO UKA. Computer navigation will be used to assess intraoperative knee kinematics in all patients undergoing CO UKA.Methods and analysisThis prospective randomised controlled trial will include 140 patients with symptomatic medial compartment knee arthritis undergoing primary UKA. Following informed consent, patients will be randomised to CO UKA (control group) or RO UKA (investigation group) at a ratio of 1:1 using an online random number generator. The primary objective of this study is to compare accuracy of implant positioning in CO UKA versus RO UKA. The secondary objectives are to compare the following outcomes between the two treatment groups: limb alignment, surgical efficiency, postoperative functional rehabilitation, functional outcomes, quality of life, range of motion, resource use, cost effectivness, and complications. Observers will review patients at regular intervals for 2 years after surgery to record predefined study outcomes pertaining to these objectives. Ethical approval was obtained from the London-Bloomsbury 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 CO UKA versus RO UKA. The findings of this study will provide an improved understanding of the differences in CO UKA versus RO UKA with respect to accuracy of implant positioning, patient satisfaction, functional outcomes, implant survivorship, cost-effectiveness, and complications.Trial registrationClinicalTrials.gov NCT04095637 . Registered on 19 September 2019.

Project description:ImportanceRecent publication of the largest trials to date investigating rehabilitation after total knee arthroplasty (TKA) necessitate an updated evidence review.ObjectiveTo determine whether inpatient or clinic-based rehabilitation is associated with superior function and pain outcomes after TKA compared with any home-based program.Data sourcesMEDLINE, Embase, CINAHL, and PubMed were searched from inception to November 5, 2018. Search terms included knee arthroplasty, randomized controlled trial, physiotherapy, and rehabilitation.Study selectionPublished randomized clinical trials of adults who underwent primary unilateral TKA and commenced rehabilitation within 6 postoperative weeks in which those receiving postacute inpatient or clinic-based rehabilitation were compared with those receiving a home-based program.Data extraction and synthesisTwo reviewers extracted data independently and assessed data quality and validity according to the PRISMA guidelines. Data were pooled using a random-effects model. Data were analyzed from June 1, 2015, through June 4, 2018.Main outcomes and measuresPrimary outcomes were mobility (6-minute walk test [6MWT]) and patient-reported pain and function (Oxford knee score [OKS] or Western Ontario and McMaster Universities Osteoarthritis Index) reported at 10 to 12 postoperative weeks. The GRADE assessment (Grading of Recommendations, Assessment, Development, and Evaluation) was applied to the primary outcomes.ResultsFive unique studies involving 752 unique participants (451 [60%] female; mean [SD] age, 68.3 [8.5] years) compared clinic- and home-based rehabilitation, and 1 study involving 165 participants (112 [68%] female; mean [SD] age, 66.9 [8.0] years) compared inpatient and home-based rehabilitation. Low-quality evidence showed no clinically important difference between clinic- and home-based programs for mobility at 10 weeks (6MWT favoring home program; mean difference [MD], -11.89 m [95% CI, -35.94 to 12.16 m]) and 52 weeks (6MWT favoring home program; MD, -25.37 m [95% CI, -47.41 to -3.32 m]). Moderate-quality evidence showed no clinically important difference between clinic- and home-based programs for patient-reported pain and function at 10 weeks (OKS MD, -0.15 [95% CI, -0.35 to 0.05]) and 52 weeks (OKS MD, 0.10 [95% CI, -0.14 to 0.34]).Conclusions and relevanceBased on low- to moderate-quality evidence, no superiority of clinic-based or inpatient programs compared with home-based programs was found in the early subacute period after TKA. This evidence suggests that home-based rehabilitation is an appropriate first line of therapy after uncomplicated TKA for patients with adequate social supports.

Project description:BackgroundThe length of hospital stay after lower limb arthroplasty has rapidly decreased in the last decade, largely in part due to the rise of improved perioperative protocols, but also as a response to the increased economic demand associated with the rapid growth in hip and knee arthroplasty procedures. In line with this, the development of a new pathway after lower limb arthroplasty that allows for the surgery to be performed in an outpatient setting and permits for same-day discharge after the procedure is increasingly being offered. Although costs and complications between the inpatient and outpatient models have been compared, there appears to be little known about the effects on a patient's physical function after undergoing hip or knee outpatient arthroplasty. Therefore, this systematic review aims to explore the available evidence for the effect on functional outcomes following inpatient versus outpatient hip or knee arthroplasty.MethodsThis systematic review adhered to the PRISMA guidelines and was prospectively registered ( https://osf.io/8bfae/ ). An electronic search of three online databases (PubMed, CINAHL and EMBASE) was conducted to identify eligible studies. All studies investigating inpatient and outpatient comparator groups, for a population of patients undergoing hip or knee arthroplasty, that assessed one or more functional outcomes, were included. A methodological quality appraisal was undertaken for the final studies contained in this review. A narrative synthesis of results is described along with quantitative outcomes presented in tables and figures.ResultsA total of seven studies containing 1,876 participants were included in this review. Four studies assessed a THA population, two assessed TKA and one assessed both. Functional outcomes varied, with 20 different functional outcomes utilised, of which 18 were patient-reported tools. Results of functional outcomes offered mixed support for both inpatient and outpatient pathways.ConclusionsThe results of this review suggest that outpatient or inpatient pathway selection for hip or knee arthroplasty should not be based on the superiority of functional outcomes alone. However, given there is growing evidence in support of an outpatient pathway in select patients with respect to cost savings and without any increase in complications, it could be proposed that an equivalency of post-operative function between the two settings makes same-day discharge favourable. Publicly registered with Open Science Framework ( https://osf.io/8bfae/ ).

Project description:BackgroundExpenditure for rehabilitation following knee arthroplasty for osteoarthritis- and rehabilitation-related challenges following discharge to home after surgery is not available in the Indian context.ObjectivesTo estimate cost of rehabilitation and document challenges in following rehabilitation advices, from a patient perspective.MethodsWe conducted a hospital-based cross-sectional study of patients visiting the orthopedic department at a tertiary care public-funded hospital in New Delhi and included those who recently (less than 4 months) underwent primary knee arthroplasty for osteoarthritis. A trained physiotherapist not involved in clinical care collected information on expenditures incurred after discharge from hospital, patient's ability to recall the advices given by the physician and challenges they experienced using a semi-structured questionnaire. We report median costs by category of direct and indirect cost and used linear regression to explore determinants of cost.ResultsWe interviewed 82 consecutive patients (mean age 60.8 years and 68% females) with median time since surgery of 28 days. More than half (52%) sought some support for physiotherapy. The median cost of rehabilitation was INR 18,395 (Interquartile-range 11,325-27,775). Direct medical cost contributed to 74% of total cost (32% fee for services, 21% medications and lab investigations, 21% assistive devices). Twenty percent higher costs were incurred among those undergoing bilateral knee surgery after adjusting for age, sex, income, and type of physiotherapy support sought. Challenges were related to recall of advices, not understanding the recovery process and pain management.ConclusionAbout half patients undergoing knee arthroplasty seek support for rehabilitation after discharge to home contributing to a major portion of expenses incurred during rehabilitation. Cost-effective support mechanism for home-based rehabilitation is required for improving patient rehabilitation experiences.Supplementary informationThe online version contains supplementary material available at 10.1007/s43465-021-00405-6.

Project description:BACKGROUND:The morbidity of knee arthritis is increasing among aged people and total knee arthroplasty has been its mainstream treatment to date. Postoperative rehabilitation is an important part of the procedure. However, the intense pain during the functional exercise involved has always been a challenge for both patients and health care professionals. The aim of this study is to test the analgesic effect of a mixture of nitrous oxide/oxygeb (1:1) inhalation for patients who are doing functional exercise 1 month after total knee arthroplasty. METHODS/DESIGN:This double-blind, randomized, placebo-controlled study will be implemented in the Rehabilitation Department in the General Hospital of Ningxia Medical University. Patients aged between 50 and 75 years who underwent a primary unilateral total knee arthroplasty are eligible for inclusion. The key exclusion criteria include: epilepsy, pulmonary embolism, intestinal obstruction, aerothorax. The treatment group (A) will receive a pre-prepared nitrous oxide/oxygen mixture plus conventional treatment (no analgesics), and the control group (B) will receive oxygen plus conventional treatment (no analgesics). Patients, physicians, therapists, and data collectors are all blind to the experiment. Assessments will be taken immediately after functional exercise begins (T0), 5 min (T1) after functional exercise begins, and 5 min after functional exercise has finished (T2). Patients will be randomly allocated between a treatment group (A) and a control group (B) in a ratio of 1:1. Primary outcome, including pain severity in the procedure, will be taken for each group. Secondary outcomes include blood pressure, heart rate, oxygen saturation, side effects, knee joint range of motion, Knee Society Score (KSS), rescue analgesia need, and satisfaction from both therapists and patients. DISCUSSION:This study will focus on exploring a fast and efficient analgesic for patients who are doing functional exercise after total knee arthroplasty. Our previous studies suggested that the prefixed nitrous oxide/oxygen mixture was an efficacious analgesic for the management of burn-dressing pain and breakthrough cancer pain. The results of this study should provide a more in-depth insight into the effects of this analgesic method. If this treatment proves successful, it could be implemented widely for patients doing functional exercise in the rehabilitation department. TRIAL REGISTRATION:ChiCTR-INR-17012891 . Registered on 6 October 2017.

Dataset Information

Hospital Inpatient versus HOme-based rehabilitation after knee arthroplasty (The HIHO study): study protocol for a randomized controlled trial.

Publications

Hospital Inpatient versus HOme-based rehabilitation after knee arthroplasty (The HIHO study): study protocol for a randomized controlled trial.

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