Aims. This study aims to define a set of family-centred core outcomes for infants undergoing brace treatment to facilitate consistent reporting for future high-quality research. Methods. Family-centred outcomes will be identified through a literature review and a scoping survey involving key stakeholders, including parents, healthcare professionals, and researchers. These outcomes will then be rated for their perceived importance in a two-stage modified Delphi process with the same stakeholders. Finally, a consensus meeting will be held to establish the final core outcome set (COS). Conclusion. The impact of brace treatment on the family is profound, but seldom considered in randomized controlled trials. This
A Core Outcome Set (COS) for treatment of adolescent idiopathic scoliosis (AIS) is essential to ensure that the most meaningful outcomes are evaluated and used consistently. Measuring the same outcomes ensures evidence from clinical trials and routine clinical practice of different treatments can be more easily compared and combined, therefore increasing the quality of the evidence base. The SPINE-COS-AYA project aims to develop a gold standard
Aims. The aim of this study is to define a core outcome set (COS) to allow consistency in outcome reporting amongst studies investigating the management of orthopaedic treatment in children with spinal dysraphism (SD). Methods. Relevant outcomes will be identified in a four-stage process from both the literature and key stakeholders (patients, their families, and clinical professionals). Previous outcomes used in clinical studies will be identified through a systematic review of the literature, and each outcome will be assigned to one of the five core areas, defined by the Outcome Measures in Rheumatoid Arthritis Clinical Trials (OMERACT). Additional possible outcomes will be identified through consultation with patients affected by SD and their families. Results. Outcomes identified in these stages will be included in a two-round Delphi process that will involve key stakeholders in the management of SD. A final list including the identified outcomes will then be summarized in a consensus meeting attended by representatives of the key stakeholders groups. Conclusion. The best approach to provision of orthopaedic care in patients with SD is yet to be decided. The reporting of different outcomes to define success among studies, often based on personal preferences and local culture, has made it difficult to compare the effect of treatments for this condition. The development of a
Aims. To identify the minimum set of outcomes that should be collected in clinical practice and reported in research related to the care of children with idiopathic congenital talipes equinovarus (CTEV). Methods. A list of outcome measurement tools (OMTs) was obtained from the literature through a systematic review. Further outcomes were collected from patients and families through a questionnaire and interview process. The combined list, as well as the appropriate follow-up timepoint, was rated for importance in a two-round Delphi process that included an international group of orthopaedic surgeons, physiotherapists, nurse practitioners, patients, and families. Outcomes that reached no consensus during the Delphi process were further discussed and scored for inclusion/exclusion in a final consensus meeting involving international stakeholder representatives of practitioners, families, and patient charities. Results. In total, 39 OMTs were included from the systematic review. Two additional OMTs were identified from the interviews and questionnaires, and four were added after round one Delphi. Overall, 22 OMTs reached ‘consensus in’ during the Delphi and two reached ‘consensus out’; 21 OMTs reached ‘no consensus’ and were included in the final consensus meeting. In all, 21 participants attended the consensus meeting, including a wide diversity of clubfoot practitioners, parent/patient representative, and an independent chair. A total of 21 outcomes were discussed and voted upon; six were voted ‘in’ and 15 were voted ‘out’. The final
Aims. This study aims to define a set of core outcomes (COS) to allow consistent reporting in order to compare results and assist in treatment decisions for idiopathic clubfoot. Methods. A list of outcomes will be obtained in a three-stage process from the literature and from key stakeholders (patients, parents, surgeons, and healthcare professionals). Important outcomes for patients and parents will be collected from a group of children with idiopathic clubfoot and their parents through questionnaires and interviews. The outcomes identified during this process will be combined with the list of outcomes previously obtained from a systematic review, with each outcome assigned to one of the five core areas defined by the Outcome Measures Recommended for use in Randomized Clinical Trials (OMERACT). This stage will be followed by a two round Delphi survey aimed at key stakeholders in the management of idiopathic clubfoot. The final outcomes list obtained will then be discussed in a consensus meeting of representative key stakeholders. Conclusion. The inconsistency in outcomes reporting in studies investigating idiopathic clubfoot has made it difficult to define the success rate of treatments and to compare findings between studies. The development of a
INTRODUCTION:. Acetabular retroversion has been implicated as a risk factor for the development of early hip osteoarthritis. In clinical practice standard osseous signs such as the cross-over sign (COS) and the posterior wall sign (PWS) are widely used to establish the diagnosis of acetabular retroversion on plain radiographs. Despite standardized radiological evaluation protocols, an increased pelvic tilt can lead to a misdiagnosis of acetabular retroversion in AP radiographs and 2D MR or CT scans. Previous studies have shown that the elimination of observer bias using a standardized methodology based on 3D-CT models and the anterior pelvic plane (APP) for the assessment of
Aims. To analyze outcomes reported in studies of Ponseti correction of idiopathic clubfoot. Methods. A systematic review of the literature was performed to identify a list of outcomes and outcome tools reported in the literature. A total of 865 studies were screened following Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines, and 124 trials were included in the analysis. Data extraction was completed by two researchers for each trial. Each outcome tool was assigned to one of the five core areas defined by the Outcome Measures Recommended for use in Randomized Clinical Trials (OMERACT). Bias assessment was not deemed necessary for the purpose of this paper. Results. In total, 20 isolated outcomes and 16 outcome tools were identified representing five OMERACT domains. Most outcome tools were appropriately designed for children of walking age but have not been embraced in the literature. The most commonly reported isolated outcomes are subjective and qualitative. The quantitative outcomes most commonly used are ankle range of motion (ROM), foot position in standing, and muscle function. Conclusions. There is a diverse range of outcomes reported in studies of Ponseti correction of clubfoot. Until outcomes can be reported unequivocally and consistently, research in this area will be limited. Completing the process of establishing and validating
Purpose. Diagnosis of acetabular retroversion is essential in femoroacetabular impingement (FAI), but its assessment from radiographs is complicated by pelvic tilt and the two-dimensional nature of plain films. We performed a study to validate the diagnostic accuracy of the crossover sign (COS) and the posterior wall sign (PWS) in identifying acetabular retroversion. Method.
Acetabular retroversion (ARV) is a cause of femoroacetabular impingement leading to hip pain and reduced range of motion. We aimed to describe the radiological criteria used for diagnosing ARV in the literature and report on the outcomes of periacetabular osteotomy (PAO) and hip arthroscopy (HA) in its management. A systematic review using PRISMA guidelines was conducted on the MEDLINE, CINAHL, EMBASE, COCHRANE database in December 2022. English-language studies reporting outcomes of PAO, or open or arthroscopic interventions for ARV were included. From an initial 4203 studies, 21 non-randomised studies met the inclusion criteria. Eleven studies evaluated HA for ARV, with average follow-up ranging from 1 to 5 years, for a cumulative number of 996 patients. Only 3/11 studies identified ARV using AP standardized pelvic radiographs. The most frequent signs describing ARV identified were: Ischial Spine Sign (98% of patients), Posterior Wall Sign (PWS, 94%) and Crossover Sign (COS, 64%); with mean Acetabular Retroversion Index (ARI) ranging from 33% to 35%. 39% of HA patients had all three radiographic signs. Clinically significant outcomes were reached by 33–78% of patients. Eight studies evaluated PAO for ARV, with a follow-up ranging from 2 to 10 years, for a cumulative number of 379 patients. Five of the eight studies identified ARV using standardized radiographs. ISS,
Background and purpose:. Inconsistent outcome reporting is a problematic issue in systematic reviews of clinical trials in non-specific LBP (NSLBP). To facilitate statistical pooling and improve reliability of reviews, the development of a core outcome set (COS) is recommended. In 1998, Deyo et al. proposed a standardized set of domains and measurement instruments for LBP clinical research. An international steering committee (ISC) was formed to update 1998 recommendations, and to determine, at first, which outcome domains should be included in a
It has been suggested that metal ion levels are indicative of in vivo bearing performance of metal-on-metal hip replacements. A cobalt or Chromium level of 7μg/L or higher is proposed to be indicative of a bearing malfunction and the need for clinical intervention. Component design, size, acetabular orientation, patient gender and activity level have been suggested as factors leading to accelerated wear and elevated metal ions. The contact patch to rim (CPR) distance is a calculation that describes the distance from the point where a theoretical joint reaction force intersects the cup to the acetabular rim for a patient in standing position, dependent on the coverage, size, and orientation of the acetabular component. It has been suggested that CPR distance determines the hip joint susceptibility to edge loading, and the risk for increased wear and high ion levels (Langton et al JBJS Br 91: 2009). This study examined the effects of patient activity, gender, and CPR distance on serum metal ion concentrations in a series of patients treated with one type of metal on metal hip resurfacing arthroplasty (MMHRA) performed by one surgeon. 182 patients (73 females and 109 males)with a unilateral Conserve Plus (WMT, TN USA) MMHRA and had who had provided blood for metal ion analysis data from December 2000 to June 2011 were retrospectively studied. Only measurements made more than 12 months after surgery were included in order to exclude hips that had yet to reach steady-state wear. For patients with multiple draws, the most recent qualifying draw was used. Activity level was assessed by the UCLA activity score. The mean age was 51.5 years (20.0 to 77.5 years). The mean follow-up time for the last blood draw was 70 months (range, 12 to 165). Serum cobalt (CoS) and chromium (CrS) levels were analyzed using inductively coupled plasma mass spectrometry in a specialized trace element lab. Using acetabular abduction and anteversion measured by EBRA, component size, and reported coverage angle of the acetabular component, the CPR distance was calculated as previously described. Multiple logistic regression was performed to identify significant relationships between high metal ion levels (7 μg/L or greater) and gender, activity and CPR distance. The median
The aim of this study was to develop a core outcome set of what to measure in all future clinical research on hand fractures and joint injuries in adults. Phase 1 consisted of steps to identify potential outcome domains through systematic review of published studies, and exploration of the patient perspective through qualitative research, consisting of 25 semi-structured interviews and five focus groups. Phase 2 involved key stakeholder groups (patients, hand surgeons, and hand therapists) prioritizing the outcome domains via a three-round international Delphi survey, with a final consensus meeting to agree the final core outcome set.Aims
Methods
A core outcome set for adult, open lower limb fracture has been established consisting of ‘Walking, gait and mobility’, ‘Being able to return to life roles’, ‘Pain or discomfort’, and ‘Quality of life’. This study aims to identify which outcome measurement instruments (OMIs) should be recommended to measure each core outcome. A systematic review and quality assessment were conducted to identify existing instruments with evidence of good measurement properties in the open lower limb fracture population for each core outcome. Additionally, shortlisting criteria were developed to identify suitable instruments not validated in the target population. Candidate instruments were presented, discussed, and voted on at a consensus meeting of key stakeholders.Aims
Methods
Traditionally, total hip arthroplasty (THA) templating has been performed on anteroposterior (AP) pelvis radiographs. Recently, additional AP hip radiographs have been recommended for accurate measurement of the femoral offset (FO). To verify this claim, this study aimed to establish quantitative data of the measurement error of the FO in relation to leg position and X-ray source position using a newly developed geometric model and clinical data. We analyzed the FOs measured on AP hip and pelvis radiographs in a prospective consecutive series of 55 patients undergoing unilateral primary THA for hip osteoarthritis. To determine sample size, a power analysis was performed. Patients’ position and X-ray beam setting followed a standardized protocol to achieve reproducible projections. All images were calibrated with the KingMark calibration system. In addition, a geometric model was created to evaluate both the effects of leg position (rotation and abduction/adduction) and the effects of X-ray source position on FO measurement.Aims
Methods
The aim of this study is to determine the predictors of overall survival (OS) and predictive factors of poor prognosis of conventional high-grade osteosarcoma of the limbs in a single-centre in South Africa. We performed a retrospective cross-sectional analysis to identify the prognostic factors that predict the OS of patients with histologically confirmed high-grade conventional osteosarcoma of the limbs over ten years. We employed the Cox proportional regression model and the Kaplan-Meier method for statistical analysis.Aims
Methods
Open lower limb fracture is a life-changing injury affecting 11.5 per 100,000 adults each year, and causes significant morbidity and resource demand on trauma infrastructures. This study aims to identify what, and how, outcomes have been reported for people following open lower limb fracture over ten years. Systematic literature searches identified all clinical studies reporting outcomes for adults following open lower limb fracture between January 2009 and July 2019. All outcomes and outcome measurement instruments were extracted verbatim. An iterative process was used to group outcome terms under standardized outcome headings categorized using an outcome taxonomy.Aims
Methods
Open lower limb fracture is life-changing, resulting in substantial morbidity and resource demand, while inconsistent outcome-reporting hampers systematic review and meta-analysis. A core outcome set establishes consensus among key stakeholders for the recommendation of a minimum set of outcomes. This study aims to define a core outcome set for adult open lower limb fracture. Candidate outcomes were identified from a previously published systematic review and a secondary thematic analysis of 25 patient interviews exploring the lived experience of recovery from open lower limb fracture. Outcomes were categorized and sequentially refined using healthcare professional and patient structured discussion groups. Consensus methods included a multi-stakeholder two-round online Delphi survey and a consensus meeting attended by a purposive sample of stakeholders, facilitated discussion, and voting using a nominal group technique.Aims
Methods
Slipped upper femoral epiphysis (SUFE) has well documented biochemical and mechanical risk factors. Femoral and acetabular morphologies seem to be equally important. Acetabular retroversion has a low prevalence in asymptomatic adults. Hips with dysplasia, osteoarthritis, and Perthes’ disease, however, have higher rates, ranging from 18% to 48%. The aim of our study was to assess the prevalence of acetabular retroversion in patients presenting with SUFE using both validated radiological signs and tomographical measurements. A retrospective review of all SUFE surgical cases presenting to the Royal Children’s Hospital, Melbourne, Australia, from 2012 to 2019 were evaluated. Preoperative plain radiographs were assessed for slip angle, validated radiological signs of retroversion, and standardized postoperative CT scans were used to assess cranial and mid-acetabular version.Aims
Methods
Introduction. Accurate acetabular position is an important goal during THA. It is also well known that accurate acetabular positioning is very frequently not achieved, even by experienced, high volume surgeons. Problems associated with cup malposition are: dislocation, accelerated poly wear, impingement, ceramic squeaking, metalosis. Murray et al described 3 methods of measurement and assessment of acetabular inclination and anteversion (I&A): anatomic, radiographic and operative. It is the hypothesis of the authors, that the differences and details of these 3 methods are poorly understood by many surgeons and this is contributory to inconsistent cup positioning. Additionally, the radiographic method, which is most commonly used for post op assessment and academic studies, contributes to misunderstanding and error. Modern computer guidance and software assessment of radiographs allows us to easily measure anatomic I&A which should be thought of as “true” I&A. Methods. The mathematical criteria for radiographic measurement of anatomic I&A are defined as well as the mathematical relationships and discrepancies between anatomic and radiographic I&A for any given cup. A. =. A. n. g. l. e. . o. f. . a. n. t. e. v. e. r. s. i. o. n. . o. f. . c. u. p. I. =. A. n. g. l. e. . o. f. . i. n. c. l. i. n. a. t. i. o. n. . o. f. . c. u. p. E = Angle of ellipse major diameter to horizontal. E = Radiographic inclination. Sin. . A. =. H. o. r. i. z. o. n. t. a. l. . w. i. d. t. h. . o. f. . e. l. l. i. p. s. e. L. e. n. g. t. h. . o. f. . e. l. l. i. p. s. e. . m. a. j. o. r. . d. i. a. m. e. t. e. r. Sin. . I. =. V. e. r. t. i. c. a. l. . h. e. i. g. h. t. . o. f. . e. l. l. i. p. s. e. L. e. n. g. t. h. . o. f. . e. l. l. i. p. s. e. . m. a. j. o. r. . d. i. a. m. e. t. e. r. Tan I = Tan E /
Background: The purpose of this prospective study was to asses the reliability of image-free navigated cup positioning and its correlation with biometrical parameters (age, sex, body mass index, soft tissue thickness overlying anterior superior iliac spine and symphysis pubis, and lumbar lordosis) and three different orientations of pelvis (tilt, obliquity, and rotation) in patients of Asian ethnicity. Methods: Intraoperative data was obtained from 50 consecutive total hip arthroplasties in which acetabular cup implantation was done with a cementless cup (Plasma Cup SC. ®. , Aesculap AG, Tuttlingen, Germany) using Orthopilot. ®. image-free navigation system. The data was then compared with mathematically calculated synchronized anteversion and inclination obtained postoperatively through computed tomography and 3-dimensional processing. Results: Mean navigated and synchronized inclination obtained were 40.1°±5.34° and 41.79°± 7.96° respectively (mean difference 1.69°±6.95°, range −20.72° ~ 18.47°), while the mean navigated and synchronized anteversion were 19.98°± 6.44° and 20.00°± 6.33° (mean difference 0.01°±6.35°, range −15.15° ~ 11.10°). A discrepancy of >
10° was observed in 5 hips in inclination and 5 hips in anteversion. No correlation was found between all of biometrical parameters and discrepancy of cup orientation. A statistically significant correlation was found between discrepancy of anteversion and pelvic tilt (1.78 + 0.55 x pelvic tilt°, r=0.493, p=0.0016). Conclusion: In spite of variations in pelvic geometry, image-free navigation assisted acetabular cup positioning showed the significant reliability. The next generation of navigation systems must be combined with data on precision of pelvic orientation intraoperatively for complete validation. *Index; Synchronized Inclination = arctan [tan (Operative AV) ÷ tan (Anatomic AV)] Synchronized AV = arctan[tan (Anatomic AV) x sin (synchronized Inclination)] or arctan[tan (Operative AV) x