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

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          Abstract

          Background

          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.

          Methods/Design

          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.

          Discussion

          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.

          Trial registration

          ClinicalTrials.gov NCT02107248, registration date 3 April 2014.

          Related collections

          Most cited references 17

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          Hip arthroplasty.

          Total hip arthroplasty is a cost-effective surgical procedure undertaken to relieve pain and restore function to the arthritic hip joint. More than 1 million arthroplasties are done every year worldwide, and this number is projected to double within the next two decades. Symptomatic osteoarthritis is the indication for surgery in more than 90% of patients, and its incidence is increasing because of an ageing population and the obesity epidemic. Excellent functional outcomes are reported; however, careful patient selection is needed to achieve best possible results. The present economic situation in many developed countries will place increased pressure on containment of costs. Future demand for hip arthroplasty, especially in patients younger than 65 years, emphasises the need for objective outcome measures and joint registries that can track lifetime implant survivorship. New generations of bearing surfaces such as metal-on-metal, ceramic-on-ceramic, and metal-on-ceramic, and techniques such as resurfacing arthroplasty have the potential to improve outcomes and survivorship, but findings from prospective trials are needed to show efficacy. With the recall of some metal-on-metal bearings, new bearing surfaces have to be monitored carefully before they can be assumed to be better than traditional bearings. Copyright © 2012 Elsevier Ltd. All rights reserved.
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            Posterior approach to total hip replacement using enhanced posterior soft tissue repair.

            The two senior authors (PMP, RP) independently began using an identical enhanced posterior soft tissue repair after total hip replacement through a posterior approach. In the first author's experience, a dislocation rate of 4% in 395 patients before using the enhanced closure was reduced to 0% in 395 patients in whom the enhanced closure was performed. In the second author's experience, 160 total hip replacements had a dislocation rate of 6.2% before the enhanced closure whereas 124 total hip replacements had a dislocation rate of 0.8% after the enhanced closure. These results are highly statistically significant.
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              The risk of revision due to dislocation after total hip arthroplasty depends on surgical approach, femoral head size, sex, and primary diagnosis

              Background and purpose The effects of patient-related and technical factors on the risk of revision due to dislocation after primary total hip arthroplasty (THA) are only partly understood. We hypothesized that increasing the femoral head size can reduce this risk, that the lateral surgical approach is associated with a lower risk than the posterior and minimally invasive approaches, and that gender and diagnosis influence the risk of revision due to dislocation. Patients and methods Data on 78,098 THAs in 61,743 patients performed between 2005 and 2010 were extracted from the Swedish Hip Arthroplasty Register. Inclusion criteria were a head size of 22, 28, 32, or 36 mm, or the use of a dual-mobility cup. The covariates age, sex, primary diagnosis, type of surgical approach, and head size were entered into Cox proportional hazards models in order to calculate the adjusted relative risk (RR) of revision due to dislocation, with 95% confidence intervals (CI). Results After a mean follow-up of 2.7 (0–6) years, 399 hips (0.5%) had been revised due to dislocation. The use of 22-mm femoral heads resulted in a higher risk of revision than the use of 28-mm heads (RR = 2.0, CI: 1.2–3.3). Only 1 of 287 dual-mobility cups had been revised due to dislocation. Compared with the direct lateral approach, minimally invasive approaches were associated with a higher risk of revision due to dislocation (RR = 4.2, CI: 2.3–7.7), as were posterior approaches (RR = 1.3, CI: 1.1–1.7). An increased risk of revision due to dislocation was found for the diagnoses femoral neck fracture (RR = 3.9, CI: 3.1–5.0) and osteonecrosis of the femoral head (RR = 3.7, CI: 2.5–5.5), whereas women were at lower risk than men (RR = 0.8, CI: 0.7–1.0). Restriction of the analysis to the first 6 months after the index procedure gave similar risk estimates. Interpretation Patients with femoral neck fracture or osteonecrosis of the femoral head are at higher risk of dislocation. Use of the minimally invasive and posterior approaches also increases this risk, and we raise the question of whether patients belonging to risk groups should be operated using lateral approaches. The use of femoral head diameters above 28 mm or of dual-mobility cups reduced this risk in a clinically relevant manner, but this observation was not statistically significant.
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                Author and article information

                Contributors
                a.peters@ocon.nl
                m.tijink@ocon.nl
                anneveldhuijzen@hotmail.com
                r.huis@ocon.nl
                Journal
                Trials
                Trials
                Trials
                BioMed Central (London )
                1745-6215
                18 August 2015
                18 August 2015
                2015
                : 16
                Affiliations
                Center for Orthopedic Surgery OCON, Geerdinksweg 141, 7555 DL Hengelo, The Netherlands
                Article
                901
                10.1186/s13063-015-0901-0
                4539699
                © Peters et al. 2015

                Open Access This article is distributed under the terms of the Creative Commons Attribution 4.0 International License ( http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver ( http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.

                Categories
                Study Protocol
                Custom metadata
                © The Author(s) 2015

                Medicine

                precautions, posterolateral surgery, hip, replacement, arthroplasty

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