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      Curved versus Straight Stem Uncemented Total Hip Arthroplasty Osteoarthritis Multicenter trial (CUSTOM): design of a prospective blinded randomised controlled multicentre trial

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          Abstract

          Introduction

          Answering the demands of an increasingly young and active patient population, recent developments in total hip arthroplasty (THA) have shifted towards minimising tissue damage. The Collum Femoris Preserving (CFP) stem was developed to preserve the trochanteric region of the femur, which potentially preserves the insertion of the gluteus musculature. This might accelerate early postoperative rehabilitation and improve functional outcome. Currently the functional results of the CFP stem have not been compared with conventional straight stems in a randomised controlled trial (RCT). The primary purpose of this trial is to compare the functional result of CFP stem THA with conventional uncemented straight stem THA, measured by the Dutch Hip disability and Osteoarthritis Outcome Score (HOOS) at 3-month follow-up.

          Methods

          A prospective blinded multicentre RCT will be performed. We aim to recruit 150 patients. The patients will be randomly allocated to a THA with a straight or a curved stem. All patients, research assistants, clinical assessors and investigators will be blinded for the type of prosthesis for 5 years. Clinical assessments and roentgenograms will be taken preoperative, at 6 weeks after surgery, at 1, 2, 3, 4 and 5 years after surgery. Patient reported outcome measures (PROMs) will be obtained at the same follow-up moments. In addition, the PROMs will also be sent to the patients at 3 and 6 months after surgery. The HOOS at 3-month follow-up will be our primary outcome.

          Ethics and dissemination

          This trial will be performed in accordance with the Declaration of Helsinki. A local ethics committee has approved this trial. Written informed consent will be obtained from all participating patients. All serious adverse events will be reported to the ethics committee.

          Results

          Results will be submitted for publication to an orthopaedics related journal.

          Trial registration number

          NTR1560.

          Related collections

          Most cited references36

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          Short bone-conserving stems in cementless hip arthroplasty.

          ➤ Short bone-conserving femoral stems in total hip arthroplasty were designed to preserve proximal bone stock.➤ Given the distinct fixation principles and location of loading among these bone-conserving stems, a classification system is essential to compare clinical outcomes.➤ Due to the low quality of currently available evidence, only a weak recommendation can be provided for clinical usage of certain stem designs, while some other designs cannot be recommended at this time.➤ A high prevalence of stem malalignment, incorrect sizing, subsidence, and intraoperative fractures has been reported in a subset of these short stem designs.➤ Stronger evidence, including prospective multicenter randomized trials comparing standard stems with these newer designs, is necessary before widespread use can be recommended.
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            The quality of reporting of randomized trials in the Journal of Bone and Joint Surgery from 1988 through 2000.

            The purpose of this study was threefold: (1) to determine the scientific quality of published randomized trials in the American Volume of The Journal of Bone and Joint Surgery from 1988 through 2000, (2) to identify predictors of study quality, and (3) to evaluate inter-rater agreement in the scoring of study quality with use of a simple scale. Hand searches of The Journal of Bone and Joint Surgery were conducted in duplicate to identify randomized clinical trials. Of 2468 studies identified, seventy-two (2.9%) met all eligibility criteria. Two investigators each assessed the quality of the study under blinded conditions and abstracted relevant data. The mean score (and standard error) for the quality of the seventy-two randomized trials was 68.1% plus minus 1.6%; 60% (forty-three) scored <75%. Drug trials had a significantly higher mean quality score than did surgical trials (72.8% compared with 63.9%, p < 0.05). Regression analysis revealed that cited affiliation with an epidemiology department and cited funding were associated with higher quality scores. Failure to conceal randomization, to blind outcome assessors, and to describe why patients were excluded resulted in significantly lower quality scores (p < 0.05), more than the 5% decrease expected by removal of each item. A priori calculations of sample size were rarely performed in the reviewed studies, and only 2% of the studies with negative results included a post hoc power analysis. The Detsky quality scale met accepted standards of interobserver reliability (kappa, 0.87; 95% confidence interval, 0.70 to 0.95). Few studies published in The Journal of Bone and Joint Surgery were randomized trials. More than half of the trials were limited by a lack of concealed randomization, lack of blinding of outcome assessors, or failure to report reasons for excluding patients. Application of standardized guidelines for the reporting of clinical trials in orthopaedics should improve quality.
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              Abductor tendons and muscles assessed at MR imaging after total hip arthroplasty in asymptomatic and symptomatic patients.

              To prospectively evaluate magnetic resonance (MR) imaging findings of abductor tendons and muscles in asymptomatic and symptomatic patients after lateral transgluteal total hip arthroplasty (THA). The institutional review board approved the study, and all patients provided informed consent. Two musculoskeletal radiologists blinded to clinical information analyzed triplanar MR images of the greater trochanter obtained in 25 patients without and 39 patients with trochanteric pain and abductor weakness after THA. Tendon defects, diameter, signal intensity, and ossification; fatty atrophy; and bursal fluid collections were assessed. In 14 symptomatic patients, MR imaging and surgical findings were correlated. Differences in the frequencies of findings between the two groups were tested for significance by using chi2 analysis. Tendon defects were uncommon in asymptomatic patients and significantly more frequent in symptomatic patients: Two asymptomatic versus 22 symptomatic patients had gluteus minimus defects (P < .001); four asymptomatic versus 24 symptomatic patients, lateral gluteus medius defects (P < .001); and no asymptomatic versus seven symptomatic patients, posterior gluteus medius defects (P = .025). In both patient groups, tendon signal intensity changes were frequent, with the exception of those in the posterior gluteus medius tendon, which demonstrated these changes more frequently in symptomatic patients (in 23 vs five asymptomatic patients, P = .002). Tendon diameter changes were frequent in both groups but significantly (P = .001 to P = .009) more frequent in symptomatic patients (all tendon parts). Fatty atrophy was evident in the anterior two-thirds of the gluteus minimus muscle in both groups, without significant differences. In the posterosuperior third of the gluteus minimus muscle, however, differences in fatty atrophy between the two groups were significant (P = .026). Fatty atrophy of the gluteus medius muscle was present in symptomatic patients only, with significant differences among all muscle parts. Bursal fluid collections were more frequent in symptomatic patients (n = 24) than in asymptomatic patients (n = 8, P = .021). The MR imaging-based diagnosis was confirmed in all 14 patients who underwent revision surgery. Abductor tendon defects and fatty atrophy of the gluteus medius muscle and the posterior part of the gluteus minimus muscle are uncommon in asymptomatic patients after THA. Copyright RSNA, 2005.
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                Author and article information

                Journal
                BMJ Open
                BMJ Open
                bmjopen
                bmjopen
                BMJ Open
                BMJ Publishing Group (BMA House, Tavistock Square, London, WC1H 9JR )
                2044-6055
                2016
                23 March 2016
                : 6
                : 3
                : e010472
                Affiliations
                [1 ]Department of Orthopaedic Surgery, Joint ResearchOnze Lieve Vrouwe Gasthuis (OLVG) AmsterdamThe Netherlands
                [2 ]Department of Orthopaedic SurgeryAcademic Medical Center (AMC) AmsterdamThe Netherlands
                [3 ]Department of Orthopaedic SurgeryIkazia Hospital RotterdamThe Netherlands
                [4 ]Department of SurgeryMcMaster University Hospital Hamilton, OntarioCanada
                Author notes
                [Correspondence to ] Loes W A H van Beers; l.w.a.h.vanbeers@ 123456olvg.nl
                Article
                bmjopen-2015-010472
                10.1136/bmjopen-2015-010472
                4809092
                27009147
                befeae06-aa59-41a0-ba13-3254f765c40e
                Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/

                This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/

                History
                : 9 November 2015
                : 30 December 2015
                : 21 January 2016
                Categories
                Surgery
                Protocol
                1506
                1737
                1730

                Medicine
                orthopaedic & trauma surgery
                Medicine
                orthopaedic & trauma surgery

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