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A randomized controlled trial protocol for an interdisciplinary evaluation of non-arthritic hip disease.

ABSTRACT: Background:Non-arthritic hip disease (NAHD) is a clinical condition often accompanied by painful movement. Current literature is lacking regarding how movement abnormalities are evaluated and treated in this population, which may be key to identifying which patients may respond to non-operative versus operative treatment. Combining the expertise of a hip arthroscopist and physical therapist may better inform treatment decisions for persons with NAHD. The primary objective of this study is to identify the extent to which an interdisciplinary evaluation between a physical therapist and surgeon influences treatment decisions of persons presenting to a hip preservation clinic. Rationale for study design:A prospective, randomized controlled trial provides the ability to identify cause and effect of this new evaluation type. Methods:Ninety-six adults with unilateral, NAHD presenting to a hip preservation clinic for initial evaluation will be randomized to receive either a standard evaluation with a surgeon or an interdisciplinary evaluation by a physical therapist and surgeon. Regardless of group, the surgeon conducts a standard-care examination. For participants in the interdisciplinary group, the physical therapist conducts an assessment of 6 postures and movements to identify asymmetrical, abnormal, or painful strategies. Treatment selection(s) and decisional conflict will be compared between groups after the evaluations. Discussion:Persons with NAHD may experience considerable decisional conflict because of prolonged duration of symptoms and minimal evidence to compare operative and non-operative treatment for this population. The findings of this study have the potential to improve patient experience and produce more informed and supported treatment decisions for persons considering surgical treatment for NAHD.

SUBMITTER: Brown L

PROVIDER: S-EPMC6583806 | biostudies-literature | 2019

REPOSITORIES: biostudies-literature

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A randomized controlled trial protocol for an interdisciplinary evaluation of non-arthritic hip disease.

Brown Lindsey L Harris-Hayes Marcie M Foraker Randi R Glaws Kathryn K Vasileff W Kelton WK Di Stasi Stephanie S

European journal for person centered healthcare 20190101 1

<h4>Background</h4>Non-arthritic hip disease (NAHD) is a clinical condition often accompanied by painful movement. Current literature is lacking regarding how movement abnormalities are evaluated and treated in this population, which may be key to identifying which patients may respond to non-operative <i>versus</i> operative treatment. Combining the expertise of a hip arthroscopist and physical therapist may better inform treatment decisions for persons with NAHD. The primary objective of this ...[more]

PMID: 31217989

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Project description:Residual disability after stroke is substantial; 65% of patients at 6 months are unable to incorporate the impaired upper extremity into daily activities. Task-oriented training programs are rapidly being adopted into clinical practice. In the absence of any consensus on the essential elements or dose of task-specific training, an urgent need exists for a well-designed trial to determine the effectiveness of a specific multidimensional task-based program governed by a comprehensive set of evidence-based principles. The Interdisciplinary Comprehensive Arm Rehabilitation Evaluation (ICARE) Stroke Initiative is a parallel group, three-arm, single blind, superiority randomized controlled trial of a theoretically-defensible, upper extremity rehabilitation program provided in the outpatient setting.The primary objective of ICARE is to determine if there is a greater improvement in arm and hand recovery one year after randomization in participants receiving a structured training program termed Accelerated Skill Acquisition Program (ASAP), compared to participants receiving usual and customary therapy of an equivalent dose (DEUCC). Two secondary objectives are to compare ASAP to a true (active monitoring only) usual and customary (UCC) therapy group and to compare DEUCC and UCC.Following baseline assessment, participants are randomized by site, stratified for stroke duration and motor severity. 360 adults will be randomized, 14 to 106 days following ischemic or hemorrhagic stroke onset, with mild to moderate upper extremity impairment, recruited at sites in Atlanta, Los Angeles and Washington, D.C. The Wolf Motor Function Test (WMFT) time score is the primary outcome at 1 year post-randomization. The Stroke Impact Scale (SIS) hand domain is a secondary outcome measure.The design includes concealed allocation during recruitment, screening and baseline, blinded outcome assessment and intention to treat analyses. Our primary hypothesis is that the improvement in log-transformed WMFT time will be greater for the ASAP than the DEUCC group. This pre-planned hypothesis will be tested at a significance level of 0.05.ICARE will test whether ASAP is superior to the same number of hours of usual therapy. Pre-specified secondary analyses will test whether 30 hours of usual therapy is superior to current usual and customary therapy not controlled for dose.www.ClinicalTrials.gov Identifier: NCT00871715

Project description:OBJECTIVE:Stroke is the fifth leading cause of death and the leading cause of serious long-term adult disability in the US. Acute stroke treatments with intravenous thrombolysis and endovascular therapy are proven to reduce disability, however a critical limitation on their effectiveness is the narrow time window for administration, which is 4.5 hours and 6 hours respectively from the onset of symptoms. Our overarching goal is to reduce pre-hospital delays to acute stroke treatments in economically disadvantaged minority communities where the greatest delays exist, using Hip Hop Stroke. METHODS:Hip Hop Stroke (HHS) is a school-based, child-mediated, culturally-tailored stroke communication multimedia intervention developed using validated models of behavior change and designed to improve stroke literacy (knowledge of stroke symptoms, the urgent need to call 911, and prevention measures) of 4th, 5th and 6th grade students and their parents residing in poor urban communities. Children in the intervention arm will receive the HHS intervention, while those in the attentional control arm will receive standardized nutrition education based on the USDA's MyPyramid program. Children will be trained and motivated to share stroke information with their parents or other adult caregiver. Both children and parents will complete a stroke knowledge assessment at baseline, immediately following the program, and at 3-months post-program. The primary outcome is the effect of the child mediation on parental stroke literacy. CONCLUSION:Stroke literate children, a captive audience in school systems, may represent a viable channel for spreading stroke information into households of poor urban communities where mass media stroke campaigns have shown the lowest penetration. These children may also call 911 when witnessing a stroke in their homes or communities. The HHS program may highlight the potential role of children in the chain of stroke recovery as a strategy for reducing prehospital delays to acute stroke treatment.

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:BackgroundPatients affected by coxarthrosis may be treated surgically with total hip arthroplasty (THA). During the surgical intervention, the hip joint capsule can be completely removed, performing a capsulectomy. Otherwise it's possible to perform a capsulotomy, which allows for capsular conservation. Since there is no scientific evidence demonstrating the superiority of one method over the other, the choice whether to remove or conserve the capsule is at the surgeon's discretion and both procedures are actually accepted.The purpose of our study is to evaluate the differences in functional activities and proprioception in patients who underwent THA and capsulotomy with capsular conservation versus patients who underwent THA with capsulectomy.MethodsIn order to compare the two surgical techniques of capsulotomy with capsular conservation and capsulectomy, we created a randomized, controlled, double-blind, single-centre, non-pharmacological, interventional, superiority, parallel-group trial. The primary outcome of our study is evaluated using the HOOS scale (Hip disability and Osteoarthritis Outcome Score). Secondary outcomes are: the proprioceptive sensitivity, the postoperative bleeding, the surgical time, the active range of motion, and the ability to walk, sit and stand. The proprioception study is carried out through active and passive repositioning tests. THA is performed through the minimally invasive direct anterior approach. The evaluation tests are carried out in the 15 days preceding the intervention (T0), at 50-day post-operative (T1), and finally at three months after surgery (T2).DiscussionConsidering that the hip joint capsule is innervated by proprioceptive nerve endings, while the psuedocapsule that replaces the native capsule following a THA with capsulectomy doesn't have any active neurophysiological role, we hypothesize that capsulotomy with capsular conservation at the time of primary THA may lead to better proprioception and therefore better functional recovery.Trial registrationClinicalTrials.gov identifier: NCT02749058. Date of registration: 04/21/2016.

Project description:BackgroundSurgical wounds are covered to prevent bleeding, absorb the exudates, and provide a barrier against external contamination. Currently, in our hospital, after orthopedic surgery, traditional occlusive dressing of sterile gauze and non-woven hypoallergenic adhesive tape is placed. Some of the newest dressings have been shown to reduce the incidence of blisters compared with traditional dressing or colloid adhesive dressings. However, there are no comparative evaluations between the different types of dressings and their contribution to the overall results of the healing process.Methods/designThis is a randomized, controlled, open-label trial to compare five types of dressings used in total knee and hip arthroplasty surgical wounds. A total of 550 patients will be randomly allocated to one of the following dressings: (1) traditional occlusive dressing, (2) Aquacel Surgical®, (3) Mepilex® Border Post-Op, (4) OpSite Post-Op Visible, or (5) UrgoTul® Absorb Border. The dressing assigned is placed right after surgery. Patients will be followed up to 14 days after surgery when the dressing is definitively removed and will be tracked up to 3 months to record any late complications. During the immediate postoperative period and patient hospitalization and at the ambulatory visits after discharge, every time that the dressing is changed, nurses perform the study assessments. The main study outcome will be the percentage of patients with skin integrity at all times when the dressing has been changed. Skin integrity is a composite of the absence of blisters, erosion, erythema, maceration, swelling, wound dehiscence, and purulent exudates. Secondary outcomes include time to first change of dressing; percentage of patients with presence/absence of blisters, erosion, erythema, maceration, swelling, wound dehiscence, and purulent exudates; number of dressing changes needed; days of hospital stay; and nurse and patient satisfaction. Differences in the main variable between each treatment group and group 1 will be tested by means of a chi-squared test or Fisher's exact test. Subgroup analyses of diabetic and non-diabetic patients, patients with a body mass index of more than 30 or not more than 30, and type of surgery (hip or knee) are planned.DiscussionThe results of this study will be useful for clinical decision making by giving information on the contribution of the dressings studied to the outcome of the wound and may also show which dressing offers better results depending on the characteristics of patients.Trial registrationThis trial has been registered at ClinicalTrials.gov ( NCT03190447 ). Retrospectively registered on 16 June 2017.

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Dataset Information

A randomized controlled trial protocol for an interdisciplinary evaluation of non-arthritic hip disease.

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A randomized controlled trial protocol for an interdisciplinary evaluation of non-arthritic hip disease.

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