Dataset Information

Reduced patient restrictions following total hip arthroplasty: study protocol for a randomized controlled trial.

ABSTRACT: Total 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.After 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.To 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.ClinicalTrials.gov NCT02107248 , registration date 3 April 2014.

SUBMITTER: Peters A

PROVIDER: S-EPMC4539699 | biostudies-literature | 2015 Aug

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Reduced patient restrictions following total hip arthroplasty: study protocol for a randomized controlled trial.

Peters Anil A Tijink Miranda M Veldhuijzen Anne A Huis in 't Veld Rianne R

Trials 20150818

<h4>Background</h4>Total 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 sur ...[more]

PMID: 26283079

Similar Datasets

Project description:BackgroundComparisons of patient-reported outcomes (PROs) based on surgical approach for total hip arthroplasty (THA) in the United States are limited to series from single surgeons or institutions. Using prospective data from a large, multicenter study, we compare preoperative to postoperative changes in PROs between posterior, transgluteal, and anterior surgical approaches to THA.MethodsPatient-reported function, global health, and pain were systematically collected preoperatively and at 1, 3, and 6 months postoperatively from patients undergoing primary THA at 26 sites participating in the Comparative Effectiveness of Pulmonary Embolism Prevention After Hip and Knee Replacement (ClinicalTrials.gov: NCT02810704). Outcomes consisted of the brief Hip disability and Osteoarthritis Outcome Score, the Patient-Reported Outcomes Measurement Information System Physical Health score, and the Numeric Pain Rating Scale. Operative approaches were grouped by surgical plane relative to the abductor musculature as being either anterior, transgluteal, or posterior.ResultsBetween 12/12/2016 and 08/31/2019, outcomes from 3018 eligible participants were examined. At 1 month, the transgluteal cohort had a 2.2-point lower improvement in Hip disability and Osteoarthritis Outcomes Score (95% confidence interval, 0.40-4.06; P = .017) and a 1.3-point lower improvement in Patient-Reported Outcomes Measurement Information System Physical Health score (95% confidence interval, 0.48-2.04; P = .002) compared to posterior approaches. There was no significant difference in improvement between anterior and posterior approaches. At 3 and 6 months, no clinically significant differences in PRO improvement were observed between groups.ConclusionPROs 6 months following THA dramatically improved regardless of the plane of surgical approach, suggesting that choice of surgical approach can be left to the discretion of surgeons and patients without fear of differential early outcomes.

Project description:BACKGROUND:Robotic-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 ANALYSIS:This 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. DISCUSSION:This 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 REGISTRATION:ClinicalTrials.gov NCT04095845 . Registered on 19 September 2019.

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:The optimal postoperative analgesia after primary total hip arthroplasty remains in question. This randomized, double-blind, placebo-controlled study compared the use of patient-controlled epidural analgesia (PCEA) with use of a multimodal pain regimen including periarticular injection (PAI). We hypothesized that PAI would lead to earlier readiness for discharge, decreased opioid consumption, and lower pain scores.Forty-one patients received PAI, and forty-three patients received PCEA. Preoperatively, both groups were administered dexamethasone (6 mg, orally). The PAI group received a clonidine patch and sustained-release oxycodone (10 mg), while the PCEA group had placebo. Both groups received combined spinal-epidural anesthesia and used an epidural pain pump postoperatively; the PAI group had normal saline solution, while the PCEA group had bupivacaine and hydromorphone. The primary outcome, readiness for discharge, required the discontinuation of the epidural, a pain score of <4 (numeric rating scale) without parenteral narcotics, normal eating, minimal nausea, urination without a catheter, a dry surgical wound, no acute medical problems, and the ability to independently transfer and walk 12.2 m (40 ft).The mean time to readiness for discharge (and standard deviation) was 2.4 ± 0.7 days (PAI) compared with 2.3 ± 0.8 days (PCEA) (p = 0.86). The mean length of stay was 3.0 ± 0.8 days (PAI) compared with 3.1 ± 0.7 days (PCEA) (p = 0.46). A significant mean difference in pain score of 0.74 with ambulation (p = 0.01; 95% confidence interval [CI], 0.18 to 1.31) and 0.80 during physical therapy (p = 0.03; 95% CI, 0.09 to 1.51) favored the PCEA group. The mean opioid consumption (oral morphine equivalents in milligrams) was significantly higher in the PAI group on postoperative day 0 (43 ± 21 compared with 28 ± 23; p = 0.002) and postoperative days 0 through 2 (136 ± 59 compared with 90 ± 79; p = 0.004). Opioid-Related Symptom Distress Scale (ORSDS) composite scores for severity and bothersomeness as well as scores for nausea, vomiting, and itchiness were significantly higher in the PCEA group (p < 0.05). Quality of Recovery-40 scores and patient satisfaction were similar.PAI did not decrease the time to discharge and was associated with higher pain scores and greater opioid consumption but lower ORSDS scores compared with PCEA. The choice for analgesic regimen may depend on a particular patient's threshold for pain and the potential side effects.

Project description:BackgroundThe role of eHealth programs to support patients through surgical pathways, including total hip arthroplasty (THA), is rapidly growing and offers the potential to improve patient engagement, self-care, and outcomes.ObjectiveThe aim of this study is to compare the effects of an eHealth program (intervention) versus standard care for pre- and postoperative education on patient outcomes for primary THA.MethodsA prospective parallel randomized controlled trial with two arms (standard care and standard care plus access to the eHealth education program) was conducted. Participants included those who underwent THA. Outcome measures were collected preadmission, at 6 weeks, and at 3 and 6 months after surgery. The primary outcome was the Hip Dysfunction and Osteoarthritis Outcome Score. Secondary outcomes were a 5-level 5-dimension quality of life measure and the self-efficacy for managing chronic disease scale. Demographic and clinical characteristics were also collected. A satisfaction survey was completed by all participants 6 weeks after surgery, and those in the intervention arm completed an additional survey specific to the eHealth program.ResultsA total of 99 patients were recruited: 50 in the eHealth program (intervention) and 49 in standard care (control). Clinical improvements were demonstrated in both groups across all time points. Per-protocol analysis demonstrated no differences between the groups for all outcome measures across all time points. Participants in the eHealth program reported that the program was accessible, that they felt comfortable using it, and that the information was helpful.ConclusionsThis study demonstrated that the eHealth program, in addition to standard care, had no additional benefit to THA recovery compared with standard care alone. The study found that the eHealth program was highly valued by participants, and it supported the preoperative preparation, recovery, and postoperative rehabilitation of participants.Trial registrationAustralian New Zealand Clinical Trial Registry ACTRN12617001433392; http://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=373657.

Dataset Information

Reduced patient restrictions following total hip arthroplasty: study protocol for a randomized controlled trial.

Publications

Reduced patient restrictions following total hip arthroplasty: study protocol for a randomized controlled trial.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets