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Bone & Joint Open
Vol. 1, Issue 5 | Pages 167 - 174
31 May 2020
Marson BA Craxford S Deshmukh SR Grindlay D Manning J Ollivere BJ

Aims. To analyze outcomes reported in trials of childhood fractures. Methods. OVID MEDLINE, Embase, and Cochrane CENTRAL databases were searched on the eighth August 2019. A manual search of trial registries, bibliographic review and internet search was used to identify additional studies. 11,476 studies were screened following PRISMA guidelines. 100 trials were included in the analysis. Data extraction was completed by two researchers for each trial. Study quality was not evaluated. Outcomes reported by trials were mapped onto domains in the World Health Organization (WHO) International Classification of Function framework. Results. In all, 525 outcomes were identified representing 52 WHO domains. Four domains were reported in more than 50% of trials: structure of upper/lower limb, sensation of pain, mobility of joint function, and health services, systems and policies. The Activities Scale for Kids performance (ASK-p) score was the most common outcome score reported in 6/72 upper limb and 4/28 lower limb trials. Conclusion. There is a diverse range of outcomes reported in trials of childhood fractures covering all areas in the International Classification of Functioning, Disability and Health (ICF) framework. There were three common upper limb and three common lower limb outcomes. In the absence of a core outcome set, we recommend that upper limb trials report pain, range of movement and radiograph appearance of the arm and lower limb trials report pain, radiograph appearance of the leg and healthcare costs to improve consistency of reporting in future trials. Cite this article: Bone Joint Open 2020;1-5:167–174


The Bone & Joint Journal
Vol. 106-B, Issue 7 | Pages 735 - 743
1 Jul 2024
Gelfer Y Cavanagh SE Bridgens A Ashby E Bouchard M Leo DG Eastwood DM

Aims

There is a lack of high-quality research investigating outcomes of Ponseti-treated idiopathic clubfeet and correlation with relapse. This study assessed clinical and quality of life (QoL) outcomes using a standardized core outcome set (COS), comparing children with and without relapse.

Methods

A total of 11 international centres participated in this institutional review board-approved observational study. Data including demographics, information regarding presentation, treatment, and details of subsequent relapse and management were collected between 1 June 2022 and 30 June 2023 from consecutive clinic patients who had a minimum five-year follow-up. The clubfoot COS incorporating 31 parameters was used. A regression model assessed relationships between baseline variables and outcomes (clinical/QoL).


The Bone & Joint Journal
Vol. 101-B, Issue 6 | Pages 639 - 645
1 Jun 2019
Gelfer Y Wientroub S Hughes K Fontalis A Eastwood DM

Aims

The Ponseti method is the benchmark treatment for the correction of clubfoot. The primary rate of correction is very high, but outcome further down the treatment pathway is less predictable. Several methods of assessing severity at presentation have been reported. Classification later in the course of treatment is more challenging. This systematic review considers the outcome of the Ponseti method in terms of relapse and determines how clubfoot is assessed at presentation, correction, and relapse.

Patients and Methods

A prospectively registered systematic review was carried out according to Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. Studies that reported idiopathic clubfoot treated by the Ponseti method between 1 January 2012 and 31 May 2017 were included. The data extracted included demographics, Ponseti methodology, assessment methods, and rates of relapse and surgery.


Bone & Joint Open
Vol. 5, Issue 1 | Pages 69 - 77
25 Jan 2024
Achten J Appelbe D Spoors L Peckham N Kandiyali R Mason J Ferguson D Wright J Wilson N Preston J Moscrop A Costa M Perry DC

Aims. The management of fractures of the medial epicondyle is one of the greatest controversies in paediatric fracture care, with uncertainty concerning the need for surgery. The British Society of Children’s Orthopaedic Surgery prioritized this as their most important research question in paediatric trauma. This is the protocol for a randomized controlled, multicentre, prospective superiority trial of operative fixation versus nonoperative treatment for displaced medial epicondyle fractures: the Surgery or Cast of the EpicoNdyle in Children’s Elbows (SCIENCE) trial. Methods. Children aged seven to 15 years old inclusive, who have sustained a displaced fracture of the medial epicondyle, are eligible to take part. Baseline function using the Patient-Reported Outcomes Measurement Information System (PROMIS) upper limb score, pain measured using the Wong Baker FACES pain scale, and quality of life (QoL) assessed with the EuroQol five-dimension questionnaire for younger patients (EQ-5D-Y) will be collected. Each patient will be randomly allocated (1:1, stratified using a minimization algorithm by centre and initial elbow dislocation status (i.e. dislocated or not-dislocated at presentation to the emergency department)) to either a regimen of the operative fixation or non-surgical treatment. Outcomes. At six weeks, and three, six, and 12 months, data on function, pain, sports/music participation, QoL, immobilization, and analgesia will be collected. These will also be repeated annually until the child reaches the age of 16 years. Four weeks after injury, the main outcomes plus data on complications, resource use, and school absence will be collected. The primary outcome is the PROMIS upper limb score at 12 months post-randomization. All data will be obtained through electronic questionnaires completed by the participants and/or parents/guardians. The NHS number of participants will be stored to enable future data linkage to sources of routinely collected data (i.e. Hospital Episode Statistics). Cite this article: Bone Jt Open 2024;5(1):69–77


The Bone & Joint Journal
Vol. 97-B, Issue 12 | Pages 1718 - 1725
1 Dec 2015
Vanhegan IS Cashman JP Buddhdev P Hashemi-Nejad A

Slipped upper femoral epiphysis (SUFE) is the most common hip disorder to affect adolescents. Controversy exists over the optimal treatment of severe slips, with a continuing debate between in situ fixation versus corrective surgery. We present our experience in a series of 57 patients presenting with severe unilateral SUFE (defined > 50°) managed with a subcapital cuneiform osteotomy.

Between 2001 and 2011, 57 patients (35 male, 22 female) with a mean age of 13.1 years (9.6 to 20.3, SD 2.3) were referred to our tertiary referral institution with a severe slip. The affected limb was rested in slings and springs before corrective surgery which was performed via an anterior Smith-Petersen approach. Radiographic analysis confirmed an improvement in mean head–shaft slip angle from 53.8o (standard deviation (sd) 3.2) pre-operatively to 9.1o (sd 3.1) post-operatively, with minimal associated femoral neck shortening. In total 50 (88%) patients were complication free at a mean follow-up of seven years (2.8 to 13.9 years, sd 3). Their mean Oxford hip score was 44 (37 to 48) and median visual analogue pain score was 0 out of 10 (interquartile range 0 to 4). A total of six patients (10.5%) developed avascular necrosis requiring further surgery and one (1.8%) patient developed chondrolysis but declined further intervention.

This is a technically demanding operation with variable outcomes reported in the literature. We have demonstrated good results in our tertiary centre.

Cite this article: Bone Joint J 2015;97-B:1718–25.


The Bone & Joint Journal
Vol. 105-B, Issue 6 | Pages 711 - 716
1 Jun 2023
Ali MS Khattak M Metcalfe D Perry DC

Aims. This study aimed to evaluate the relationship between hip shape and mid-term function in Perthes’ disease. It also explored whether the modified three-group Stulberg classification can offer similar prognostic information to the five-group system. Methods. A total of 136 individuals aged 12 years or older who had Perthes’ disease in childhood completed the Patient-Reported Outcomes Measurement Information System (PROMIS) Mobility score (function), Nonarthritic Hip Score (NAHS) (function), EuroQol five-dimension five-level questionnaire (EQ-5D-5L) score (quality of life), and the numeric rating scale for pain (NRS). The Stulberg class of the participants’ hip radiographs were evaluated by three fellowship-trained paediatric orthopaedic surgeons. Hip shape and Stulberg class were compared to PROM scores. Results. A spherical hip was associated with the highest function and quality of life, and lowest pain. Conversely, aspherical hips exhibited the lowest functional scores and highest pain. The association between worsening Stulberg class (i.e. greater deviation from sphericity) and worse outcome persisted after adjustment for age and sex in relation to PROMIS (predicted mean difference -1.77 (95% confidence interval (CI) -2.70 to -0.83)), NAHS (-5.68 (95% CI -8.45 to -2.90)), and NRS (0.61 (95% CI 0.14 to 1.08)), but not EQ-5D-5L (-0.03 (95% CI -0.72 to 0.11)). Conclusion. Patient-reported outcomes identify lower function, quality of life, and higher pain in aspherical hips. The magnitude of symptoms deteriorated with time. Hip sphericity (i.e. the modified three-group classification of spherical, oval, and aspherical) appeared to offer similar levels of detail to the five-group Stulberg classification. Cite this article: Bone Joint J 2023;105-B(6):711–716


The Journal of Bone & Joint Surgery British Volume
Vol. 88-B, Issue 10 | Pages 1379 - 1384
1 Oct 2006
Biring GS Hashemi-Nejad A Catterall A

We reviewed prospectively, after skeletal maturity, a series of 24 patients (25 hips) with severe acute-on-chronic slipped capital femoral epiphysis which had been treated by subcapital cuneiform osteotomy. Patients were followed up for a mean of 8 years, 3 months (2 years, 5 months to 16 years, 4 months). Bedrest with ‘slings and springs’ had been used for a mean of 22 days (19 to 35) in 22 patients, and bedrest alone in two, before definitive surgery. The Iowa hip score, the Harris hip score and Boyer’s radiological classification for degenerative disease were used.

The mean Iowa hip score at follow-up was 93.7 (69 to 100) and the mean Harris hip score 95.6 (78 to 100). Degenerative joint changes were graded as 0 in 19 hips, grade 1 in four and grade 2 in two. The rate of avascular necrosis was 12% (3 of 25) and the rate of chondrolysis was 16% (4 of 25). We conclude that after a period of bed rest with slings and springs for three weeks to gain stability, subcapital cuneiform osteotomy for severe acute-on-chronic slipped capital femoral epiphysis is a satisfactory method of treatment with an acceptable rate of complication.


Bone & Joint Open
Vol. 3, Issue 1 | Pages 98 - 106
27 Jan 2022
Gelfer Y Leo DG Russell A Bridgens A Perry DC Eastwood DM

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 COS document includes nine OMTs and two existing outcome scores with a total of 31 outcome parameters to be collected after a minimum follow-up of five years. It incorporates static and dynamic clinical findings, patient-reported outcome measures, and a definition of CTEV relapse. Conclusion. We have defined a minimum set of outcomes to draw comparisons between centres and studies in the treatment of CTEV. With the use of these outcomes, we hope to allow more meaningful research and a better clinical management of CTEV. Cite this article: Bone Jt Open 2022;3(1):98–106


The Bone & Joint Journal
Vol. 103-B, Issue 2 | Pages 415 - 420
1 Feb 2021
Farr S Jauker F Ganger R Kranzl A

Aims. The aims of this study is to report the clinical and radiological outcomes after pre-, central-, and postaxial polydactyly resection in children from a tertiary referral centre. Methods. All children who underwent resection of a supernumerary toe between 2001 and 2013 were prospectively enrolled and invited for a single re-assessment. Clinical parameters and several dedicated outcome scores (visual analogue scale (VAS), Paediatric Outcomes Data Collection Instrument (PODCI), Activities Scale for Kids (ASK), and American Orthopaedic Foot and Ankle Society Score (AOFAS)) were obtained, as were radiographs of the operated and non-operated feet along with pedobarographs. Results. In all, 39 children (52 feet) with a mean follow-up of 7.2 years (3.1 to 13.0) were included in the study. Resection of a duplicated great toe was performed in ten children, central polydactyly in four, and postaxial polydactyly in 26. The mean postoperative VAS (0.7; 0 to 7), ASK (93.7; 64.2 to 100), and AOFAS range (85.9 to 89.0) indicated excellent outcomes among this cohort and the PODCI global functioning scale (95.7; 75.5 to 100) was satisfactory. No significant differences were found regarding outcomes of pre- versus postaxial patients, nor radiological toe alignment between the operated and non-operated sides. Minor complications were observed in six children (15%). There were seven surgical revisions (18%), six of whom were in preaxial patients. In both groups, below the operation area, a reduced mean and maximum force was observed. Changes in the hindfoot region were detected based on the prolonged contact time and reduced force in the preaxial group. Conclusion. Excellent mid-term results can be expected after foot polydactyly resection in childhood. However, parents and those who care for these children need to be counselled regarding the higher risk of subsequent revision surgery in the preaxial patients. Also, within the study period, the plantar pressure distribution below the operated part of the foot did not return to completely normal. Cite this article: Bone Joint J 2021;103-B(2):415–420


The Bone & Joint Journal
Vol. 103-B, Issue 2 | Pages 405 - 410
1 Feb 2021
Leo DG Perry DC Abdullah B Jones H

Aims. The reduction in mobility due to hip diseases in children is likely to affect their physical activity (PA) levels. Physical inactivity negatively influences quality of life and health. Our aim was to objectively measure PA in children with hip disease, and correlate it with the Patient-Reported Outcomes Measurement Information System (PROMIS) Mobility Score. Methods. A total of 28 children (12 boys and 16 girls) with hip disease aged between 8and 17 years (mean 12 (SD 3)) were studied between December 2018 and July 2019. Children completed the PROMIS Paediatric Item Bank v. 2.0 – Mobility Short Form 8a and wore a hip accelerometer (ActiGraph) for seven consecutive days. Sedentary time (ST), light PA (LPA), moderate to vigorous PA (MVPA), and vigorous PA were calculated from the accelerometers' data. The PROMIS Mobility score was classified as normal, mild, and moderate functions, based on the PROMIS cut scores on the physical function metric. A one-way analysis of covariance (ANCOVA) was used to assess differences among mobility (normal; mild; moderate) and measured PA and relationships between these variables were assessed using bivariate Pearson correlations. Results. Children classified as normally functioning on the PROMIS had less ST (p = 0.002), higher MVPA, (p = 0.002) and VPA (p = 0.004) compared to those classified as mild or moderate function. A moderate correlation was evident between the overall PROMIS score and daily LPA (r = 0.462, n = 28; p = 0.013), moderate-to-vigorous PA (r = 0.689, n = 28; p = 0.013) and vigorous PA (VPA) (r = 0.535, n = 28; p = 0.013). No correlation was evident between the mean daily ST and overall PROMIS score (r = -0.282, n = 28; p = 0.146). Conclusion. PROMIS Pediatric Mobility tool correlates well with experimentally measured levels of physical activity in children with hip disease. We provide external validity for the use of this tool as a measure of physical activity in children. Cite this article: Bone Joint J 2021;103-B(2):405–410


The Bone & Joint Journal
Vol. 105-B, Issue 12 | Pages 1327 - 1332
1 Dec 2023
Morris WZ Kak A Mayfield LM Kang MS Jo C Kim HKW

Aims

Abduction bracing is commonly used to treat developmental dysplasia of the hip (DDH) following closed reduction and spica casting, with little evidence to support or refute this practice. The purpose of this study was to determine the efficacy of abduction bracing after closed reduction in improving acetabular index (AI) and reducing secondary surgery for residual hip dysplasia.

Methods

We performed a retrospective review of patients treated with closed reduction for DDH at a single tertiary referral centre. Demographic data were obtained including severity of dislocation based on the International Hip Dysplasia Institute (IHDI) classification, age at reduction, and casting duration. Patients were prescribed no abduction bracing, part-time, or full-time wear post-reduction and casting. AI measurements were obtained immediately upon cast removal and from two- and four-year follow-up radiographs.


The Bone & Joint Journal
Vol. 106-B, Issue 7 | Pages 728 - 734
1 Jul 2024
Poppelaars MA van der Water L Koenraadt-van Oost I Boele van Hensbroek P van Bergen CJA

Aims

Paediatric fractures are highly prevalent and are most often treated with plaster. The application and removal of plaster is often an anxiety-inducing experience for children. Decreasing the anxiety level may improve the patients’ satisfaction and the quality of healthcare. Virtual reality (VR) has proven to effectively distract children and reduce their anxiety in other clinical settings, and it seems to have a similar effect during plaster treatment. This study aims to further investigate the effect of VR on the anxiety level of children with fractures who undergo plaster removal or replacement in the plaster room.

Methods

A randomized controlled trial was conducted. A total of 255 patients were included, aged five to 17 years, who needed plaster treatment for a fracture of the upper or lower limb. Randomization was stratified for age (five to 11 and 12 to 17 years). The intervention group was distracted with VR goggles and headphones during the plaster treatment, whereas the control group received standard care. As the primary outcome, the post-procedural level of anxiety was measured with the Child Fear Scale (CFS). Secondary outcomes included the children’s anxiety reduction (difference between CFS after and CFS before plaster procedure), numerical rating scale (NRS) pain, NRS satisfaction of the children and accompanying parents/guardians, and the children’s heart rates during the procedure. An independent-samples t-test and Mann-Whitney U test (depending on the data distribution) were used to analyze the data.


The Bone & Joint Journal
Vol. 106-B, Issue 3 | Pages 277 - 285
1 Mar 2024
Pinto D Hussain S Leo DG Bridgens A Eastwood D Gelfer Y

Aims

Children with spinal dysraphism can develop various musculoskeletal deformities, necessitating a range of orthopaedic interventions, causing significant morbidity, and making considerable demands on resources. This systematic review aimed to identify what outcome measures have been reported in the literature for children with spinal dysraphism who undergo orthopaedic interventions involving the lower limbs.

Methods

A PROSPERO-registered systematic literature review was performed following PRISMA guidelines. All relevant studies published until January 2023 were identified. Individual outcomes and outcome measurement tools were extracted verbatim. The measurement tools were assessed for reliability and validity, and all outcomes were grouped according to the Outcome Measures Recommended for use in Randomized Clinical Trials (OMERACT) filters.


The Bone & Joint Journal
Vol. 106-B, Issue 8 | Pages 871 - 878
1 Aug 2024
Pigeolet M Ghufran Syed J Ahmed S Chinoy MA Khan MA

Aims

The gold standard for percutaneous Achilles tendon tenotomy during the Ponseti treatment for idiopathic clubfoot is a tenotomy with a No. 15 blade. This trial aims to establish the technique where the tenotomy is performed with a large-bore needle as noninferior to the gold standard.

Methods

We randomized feet from children aged below 36 months with idiopathic clubfoot on a 1:1 basis in either the blade or needle group. Follow-up was conducted at three weeks and three months postoperatively, where dorsiflexion range, Pirani scores, and complications were recorded. The noninferiority margin was set at 4° difference in dorsiflexion range at three months postoperatively.


Bone & Joint Open
Vol. 4, Issue 11 | Pages 865 - 872
15 Nov 2023
Hussain SA Russell A Cavanagh SE Bridgens A Gelfer Y

Aims

The Ponseti method is the gold standard treatment for congenital talipes equinovarus (CTEV), with the British Consensus Statement providing a benchmark for standard of care. Meeting these standards and providing expert care while maintaining geographical accessibility can pose a service delivery challenge. A novel ‘Hub and Spoke’ Shared Care model was initiated to deliver Ponseti treatment for CTEV, while addressing standard of care and resource allocation. The aim of this study was to assess feasibility and outcomes of the corrective phase of Ponseti service delivery using this model.

Methods

Patients with idiopathic CTEV were seen in their local hospitals (‘Spokes’) for initial diagnosis and casting, followed by referral to the tertiary hospital (‘Hub’) for tenotomy. Non-idiopathic CTEV was managed solely by the Hub. Primary and secondary outcomes were achieving primary correction, and complication rates resulting in early transfer to the Hub, respectively. Consecutive data were prospectively collected and compared between patients allocated to Hub or Spokes. Mann-Whitney U test, Wilcoxon signed-rank test, or chi-squared tests were used for analysis (alpha-priori = 0.05, two-tailed significance).


The Bone & Joint Journal
Vol. 105-B, Issue 2 | Pages 198 - 208
1 Feb 2023
Cheok T Smith T Wills K Jennings MP Rawat J Foster B

Aims

We investigated the prevalence of late developmental dysplasia of the hip (DDH), abduction bracing treatment, and surgical procedures performed following the implementation of universal ultrasound screening versus selective ultrasound screening programmes.

Methods

A systematic search of PubMed, Embase, The Cochrane Library, OrthoSearch, and Web of Science from the date of inception of each database until 27 March 2022 was performed. The primary outcome of interest was the prevalence of late detection of DDH, diagnosed after three months. Secondary outcomes of interest were the prevalence of abduction bracing treatment and surgical procedures performed in childhood for dysplasia. Only studies describing the primary outcome of interest were included.


The Bone & Joint Journal
Vol. 100-B, Issue 6 | Pages 822 - 827
1 Jun 2018
Pollet V Van Dijk L Reijman M Castelein RMC Sakkers RJB

Aims. Open reduction is required following failed conservative treatment of developmental dysplasia of the hip (DDH). The Ludloff medial approach is commonly used, but poor results have been reported, with rates of the development of avascular necrosis (AVN) varying between 8% and 54%. This retrospective cohort study evaluates the long-term radiographic and clinical outcome of dislocated hips treated using this approach. Patients and Methods. Children with a dislocated hip, younger than one year of age at the time of surgery, who were treated using a medial approach were eligible for the study. Radiographs were evaluated for the degree of dislocation and the presence of an ossific nucleus preoperatively, and for the degree of AVN and residual dysplasia at one and five years and at a mean of 12.7 years (4.6 to 20.8) postoperatively. Radiographic outcome was assessed using the Severin classification, after five years of age. Further surgical procedures were recorded. Functional outcome was assessed using the Pediatric Outcomes Data Collection Instrument (PODCI) or the Hip Disability and Osteoarthritis Outcome Score (HOOS), depending on the patient’s age. Results. A total of 52 children (58 hips) were included. At the latest follow-up, 11 hips (19%) showed signs of AVN. Further surgery was undertaken in 13 hips (22%). A total of 13 hips had a poor radiological outcome with Severin type III or higher. Of these, the age at the time of surgery was significantly higher (p < 0.05) than in those with a good Severin type (I or II). The patient-reported outcomes were significantly worse (p < 0.05) in children with a poor Severin classification. Conclusion. This retrospective long-term follow-up study shows that one in five children with DDH who undergo open reduction using a medial surgical approach has poor clinical and/or radiological outcome. The poor outcome is not related to the presence of AVN (19%), but due to residual dysplasia. Cite this article: Bone Joint J 2018;100-B:822–7


The Bone & Joint Journal
Vol. 104-B, Issue 4 | Pages 519 - 528
1 Apr 2022
Perry DC Arch B Appelbe D Francis P Craven J Monsell FP Williamson P Knight M

Aims

The aim of this study was to inform the epidemiology and treatment of slipped capital femoral epiphysis (SCFE).

Methods

This was an anonymized comprehensive cohort study, with a nested consented cohort, following the the Idea, Development, Exploration, Assessment, Long-term study (IDEAL) framework. A total of 143 of 144 hospitals treating SCFE in Great Britain participated over an 18-month period. Patients were cross-checked against national administrative data and potential missing patients were identified. Clinician-reported outcomes were collected until two years. Patient-reported outcome measures (PROMs) were collected for a subset of participants.


The Bone & Joint Journal
Vol. 103-B, Issue 12 | Pages 1821 - 1830
1 Dec 2021
Marson BA Manning JC James M Craxford S Deshmukh SR Perry DC Ollivere BJ

Aims

The aim of this study is to develop a core set of outcome domains that should be considered and reported in all future trials of childhood limb fractures.

Methods

A four-phase study was conducted to agree a set of core outcome domains. Identification of candidate outcome domains were identified through systematic review of trials, and outcome domains relevant to families were identified through semi-structured interviews with 20 families (parent-child pairing or group). Outcome domains were prioritized using an international three-round Delphi survey with 205 panellists and then condensed into a core outcome set through a consensus workshop with 30 stakeholders.


Bone & Joint Open
Vol. 2, Issue 4 | Pages 255 - 260
15 Apr 2021
Leo DG Russell A Bridgens A Perry DC Eastwood DM Gelfer Y

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.