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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. Results. From 91 eligible studies, 27 individual outcomes were identified, including those related to clinical assessment (n = 12), mobility (n = 4), adverse events (n = 6), investigations (n = 4), and miscellaneous (n = 1). Ten outcome measurement tools were identified, of which Hoffer’s Functional Ambulation Scale was the most commonly used. Several studies used unvalidated measurement tools originally developed for other conditions, and 26 studies developed new measurement tools. On the OMERACT filter, most outcomes reported pathophysiology and/or the impact on life. There were only six patient- or parent-reported outcomes, and none assessed the quality of life. Conclusion. The outcomes that were reported were heterogenous, lack validation and failed to incorporate patient or family perceptions. Until outcomes can be reported unequivocally, research in this area will remain limited. Our findings should guide the development of a core outcome set, which will allow consistency in the reporting of outcomes for this condition. Cite this article: Bone Joint J 2024;106-B(3):277–285


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


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. 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 COS seeks to define a minimum standard set of outcomes to collect in all future clinical trials for this condition, to facilitate comparisons between studies and to aid decisions in treatment. Cite this article: Bone Jt Open 2021;2(4):255–260


Aims. Torus fractures of the distal radius are the most common fractures in children. The NICE non-complex fracture guidelines recently concluded that bandaging was probably the optimal treatment for these injuries. However, across the UK current treatment varies widely due to a lack of evidence underpinning the guidelines. The Forearm Fracture Recovery in Children Evaluation (FORCE) trial evaluates the effect of a soft bandage and immediate discharge compared with rigid immobilization. Methods. FORCE is a multicentre, parallel group randomized controlled equivalence trial. The primary outcome is the Wong-Baker FACES pain score at three days after randomization and the primary analysis of this outcome will use a multivariate linear regression model to compare the two groups. Secondary outcomes are measured at one and seven days, and three and six-weeks post-randomization and include the Patient Reported Outcome Measurement Information System (PROMIS) upper extremity limb score, EuroQoL EQ-5D-Y, analgesia use, school absence, complications, and healthcare resource use. The planned statistical and health economic analyses for this trial are described here. The FORCE trial protocol has been published separately. Conclusion. This paper provides details of the planned analyses for this trial, and will reduce the risks of outcome reporting bias and data driven results. Cite this article: Bone Joint Open 2020;1-6:205–213


The Bone & Joint Journal
Vol. 102-B, Issue 5 | Pages 611 - 617
1 May 2020
Leo DG Jones H Murphy R Leong JW Gambling T Long AF Laine J Perry DC

Aims. To identify a suite of the key physical, emotional, and social outcomes to be employed in clinical practice and research concerning Perthes' disease in children. Methods. The study follows the guidelines of the COMET-Initiative (Core Outcome Measures in Effectiveness Trials). A systematic review of the literature was performed to identify a list of outcomes reported in previous studies, which was supplemented by a qualitative study exploring the experiences of families affected by Perthes’ disease. Collectively, these outcomes formed the basis of a Delphi survey (two rounds), where 18 patients with Perthes’ disease, 46 parents, and 36 orthopaedic surgeons rated each outcome for importance. The International Perthes Study Group (IPSG) (Dallas, Texas, USA (October 2018)) discussed outcomes that failed to reach any consensus (either ‘in’ or ‘out’) before a final consensus meeting with representatives of surgeons, patients, and parents. Results. In total, 23 different outcome domains were identified from the systematic review, and a further ten from qualitative interviews. After round one of the Delphi survey, participants suggested five further outcome domains. A total of 38 outcomes were scored in round two of the Delphi. Among these, 16 outcomes were scored over the prespecified 70% threshold for importance (divided into six main categories: adverse events; life impact; resource use; pathophysiological manifestations; death; and technical considerations). Following the final consensus meeting, 14 outcomes were included in the final Core Outcome Set (COS). Conclusion. Core Outcome Sets (COSs) are important to improve standardization of outcomes in clinical research and to aid communication between patients, clinicians, and funding bodies. The results of this study should be a catalyst to develop high-quality clinical research in order to determine the optimal treatments for children with Perthes’ disease. Cite this article: Bone Joint J 2020;102-B(5):611–617


The Bone & Joint Journal
Vol. 105-B, Issue 8 | Pages 935 - 942
1 Aug 2023
Bradley CS Verma Y Maddock CL Wedge JH Gargan MF Kelley SP

Aims

Brace treatment is the cornerstone of managing developmental dysplasia of the hip (DDH), yet there is a lack of evidence-based treatment protocols, which results in wide variations in practice. To resolve this, we have developed a comprehensive nonoperative treatment protocol conforming to published consensus principles, with well-defined a priori criteria for inclusion and successful treatment.

Methods

This was a single-centre, prospective, longitudinal cohort study of a consecutive series of infants with ultrasound-confirmed DDH who underwent a comprehensive nonoperative brace management protocol in a unified multidisciplinary clinic between January 2012 and December 2016 with five-year follow-up radiographs. The radiological outcomes were acetabular index-lateral edge (AI-L), acetabular index-sourcil (AI-S), centre-edge angle (CEA), acetabular depth ratio (ADR), International Hip Dysplasia Institute (IHDI) grade, and evidence of avascular necrosis (AVN). At five years, each hip was classified as normal (< 1 SD), borderline dysplastic (1 to 2 SDs), or dysplastic (> 2 SDs) based on validated radiological norm-referenced values.


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).


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.


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.


The Bone & Joint Journal
Vol. 103-B, Issue 8 | Pages 1428 - 1437
2 Aug 2021
Vogt B Roedl R Gosheger G Frommer A Laufer A Kleine-Koenig M Theil C Toporowski G

Aims

Temporary epiphysiodesis (ED) is commonly applied in children and adolescents to treat leg length discrepancies (LLDs) and tall stature. Traditional Blount staples or modern two-hole plates are used in clinical practice. However, they require accurate planning, precise surgical techniques, and attentive follow-up to achieve the desired outcome without complications. This study reports the results of ED using a novel rigid staple (RigidTack) incorporating safety, as well as technical and procedural success according to the idea, development, evaluation, assessment, long-term (IDEAL) study framework.

Methods

A cohort of 56 patients, including 45 unilateral EDs for LLD and 11 bilateral EDs for tall stature, were prospectively analyzed. ED was performed with 222 rigid staples with a mean follow-up of 24.4 months (8 to 49). Patients with a predicted LLD of ≥ 2 cm at skeletal maturity were included. Mean age at surgery was 12.1 years (8 to 14). Correction and complication rates including implant-associated problems, and secondary deformities as well as perioperative parameters, were recorded (IDEAL stage 2a). These results were compared to historical cohorts treated for correction of LLD with two-hole plates or Blount staples.


The Bone & Joint Journal
Vol. 102-B, Issue 10 | Pages 1405 - 1411
3 Oct 2020
Martynov I Klink T Slowik V Stich R Zimmermann P Engel C Lacher M Boehm R

Aims

This exploratory randomized controlled trial (RCT) aimed to determine the splint-related outcomes when using the novel biodegradable wood-composite splint (Woodcast) compared to standard synthetic fibreglass (Dynacast) for the immobilization of undisplaced upper limb fractures in children.

Methods

An exploratory RCT was performed at a tertiary paediatric referral hospital between 1 June 2018 and 30 September 2019. The intention-to-treat population consisted of 170 patients (mean age 8.42 years (SD 3.42); Woodcast (WCG), n = 84, 57 male (67.9%); Dynacast (DNG), n = 86, 58 male (67.4%)). Patients with undisplaced upper limb fractures were randomly assigned to WCG or DNG treatment groups. Primary outcome was the stress stability of the splint material, defined as absence of any deformations or fractures within the splint during study period. Secondary outcomes included patient satisfaction and medical staff opinion. Additionally, biomechanical and chemical analysis of the splint samples was carried out.


The Bone & Joint Journal
Vol. 102-B, Issue 5 | Pages 618 - 626
1 May 2020
Zhou W Sankar WN Zhang F Li L Zhang L Zhao Q

Aims

The goal of closed reduction (CR) in the treatment of developmental dysplasia of the hip (DDH) is to achieve and maintain concentricity of the femoral head in the acetabulum. However, concentric reduction is not immediately attainable in all hips and it remains controversial to what degree a non-concentric reduction is acceptable. This prospective study is aimed at investigating the dynamic evolution of the hip joint space after CR in DDH using MRI.

Methods

A consecutive series of patients with DDH who underwent CR since March 2014 were studied. Once the safety and stability were deemed adequate intraoperatively, reduction was accepted regardless of concentricity. Concentricity was defined when the superior joint space (SJS) and medial joint space (MJS) were both less than 2 mm, based on MRI. A total of 30 children, six boys and 24 girls, involving 35 hips, were recruited for the study. The mean age at CR was 13.7 months (3.5 to 27.6) and the mean follow-up was 49.5 months (approximately four years) (37 to 60). The joint space was evaluated along with the interval between the inverted and everted limbus.


Orthopaedic Proceedings
Vol. 96-B, Issue SUPP_1 | Pages 14 - 14
1 Jan 2014
Roberts A
Full Access

Purpose:. To examine the feasibility of surgical outcome measures for a children's orthopaedic surgeon when compared with other specialties. Methods & Results:. Details of procedure codes for 2726 inpatient episodes were used to examine the distribution of procedures and the breadth of diagnoses dealt with by a variety of orthopaedic sub-specialists. The author's practice included 199 surgical cases and was compared with two arthroplasty surgeons (n=971); a spinal surgeon (n=256); a foot and ankle surgeon (n=341) and an upper limb surgeon (n=393). Arthroplasty surgeons can report 50% of their outcomes as primary knee or hip replacements the index procedure for the author is metalwork removal (14.5%). My upper limb colleague could be judged on 25% of his cases (carpal tunnel decompression) and my spinal surgical colleague on 20% of his cases (primary posterior decompression of spinal cord). Only my foot and ankle colleague compared in terms of diversity with 9% of his cases consisting of first metatarsal osteotomy and the next 9% consisting of 1st MTPJ arthrodesis. The proportion of multiple procedures also varies between sub-specialists with 66% of my cases being multiple compared with 38% for the arthroplasty surgeons and 42% for the upper limb surgeons. Foot and ankle has a high rate of multiple procedures (62%) and the spinal surgeons code different procedures at each level in the spine giving the high rates of multiple procedures. Conclusion:. Outcome measures in children's orthopaedics seem problematic owing to the diverse nature of the practice and the confusion resulting from multiple procedures contributing to the outcome in 60% of cases. Either we are treated like physicians who do not have surgical outcomes to report or some goal based measure is adopted. Level of evidence: III


The Bone & Joint Journal
Vol. 99-B, Issue 8 | Pages 1115 - 1120
1 Aug 2017
Tsukagoshi Y Kamegaya M Kamada H Saisu T Morita M Kakizaki J Tomaru Y Yamazaki M

Aims

The aim of this study was to evaluate the correlation between Salter’s criteria and Kalamchi’s classification of avascular necrosis in patients treated for developmental dysphasia of the hip (DDH).

Patients and Methods

The study involved a retrospective analysis of 123 patients (123 hips) with DDH treated by operative and non-operative reduction before the age of two years, with a minimum follow-up of ten years. Salter’s criteria (S1 to S4) were determined from radiographs obtained at one to two years post-reduction, whilst the Kalamchi grade was determined from radiographs obtained at ten or more years of age. Early post-reduction radiographs were also used to evaluate the centre-head distance discrepancy (CHDD) and the occurrence of a dome-shaped deformity of the proximal femoral metaphysis (D-shaped metaphysis).

The prognosis was described as good (Kalamchi grade K0 or KI), fair (Kalamchi grade KII) or poor (Kalamchi grade KIII or KIV) for analysis and correlation with the early Salter criteria, CHDD and D-shaped metaphysis.


The Bone & Joint Journal
Vol. 96-B, Issue 5 | Pages 691 - 700
1 May 2014
Solfelt DA Hill BW Anderson CP Cole PA

Cubitus varus is the most frequent complication following the treatment of supracondylar humeral fractures in children. We investigated data from publications reporting on the surgical management of cubitus varus found in electronic searches of Ovid/MEDLINE and Cochrane Library databases. In 894 children from 40 included studies, the mean age at initial injury was 5.7 years (3 to 8.6) and 9.8 years (4 to 15.7) at the time of secondary correction. The four osteotomy techniques were classified as lateral closing wedge, dome, complex (multiplanar) and distraction osteogenesis. A mean angular correction of 27.6º (18.5° to 37.0°) was achieved across all classes of osteotomy. The meta-analytical summary estimate for overall rate of good to excellent results was 87.8% (95% CI 84.4 to 91.2). No technique was shown to significantly affect the surgical outcome, and the risk of complications across all osteotomy classes was 14.5% (95% CI 10.6 to 18.5). Nerve palsies occurred in 2.53% of cases (95% CI 1.4 to 3.6), although 78.4% were transient. No one technique was found to be statistically safer or more effective than any other.

Cite this article: Bone Joint J 2014;96-B:691–700.


The Journal of Bone & Joint Surgery British Volume
Vol. 87-B, Issue 7 | Pages 979 - 983
1 Jul 2005
Song KS Kim HKW

We reviewed three infants with destructive osteomyelitis involving the proximal tibial epiphysis at a follow-up of eight to 22 years. All cases showed early radiographic destructive changes in the medial or lateral aspects of the epiphysis and metaphysis. Despite the ominous early appearance of the epiphysis, all cases showed spontaneous re-ossification of the epiphysis with restoration of the tibial condyle and preservation of joint congruity. The patients, however, developed a valgus or varus deformity which was treated satisfactorily with one to three proximal tibial osteotomies. The potential for regeneration of the epiphysis following infantile osteomyelitis of the proximal tibia suggests these cases should be treated expectantly with regard to joint congruity.