The Core outcome Clubfoot (CoCo) study: relapse, with poorer clinical and quality of life outcomes, affects 37% of idiopathic clubfoot patients.

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). Results: Overall, 293 patients (432 feet) with a median age of 89 months (interquartile range 72 to 113) were included. The relapse rate was 37%, with repeated relapse in 14%. Treatment considered a standard part of the Ponseti journey (recasting, repeat tenotomy, and tibialis anterior tendon transfer) was performed in 35% of cases, with soft-tissue release and osteotomies in 5% and 2% of cases, respectively. Predictors of relapse included duration of follow-up, higher initial Pirani score, and poor Evertor muscle activity. Relapse was associated with poorer outcomes. Conclusion: This is the first multicentre study using a standardized COS following clubfoot treatment. It distinguishes patients with and without relapse in terms of clinical outcomes and QoL, with poorer outcomes in the relapse group. This tool allows comparison of treatment methods and outcomes, facilitates information sharing, and sets family expectations. Predictors of relapse encourage us to create appropriate treatment pathways to reduce relapse and improve outcome.

Orthopaedic management of children with spinal dysraphism.

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.

A systematic review of tourniquet use in paediatric orthopaedic surgery: can we extrapolate from adult guidelines?

Purpose: Tourniquets are commonly used intraoperatively in orthopaedic surgery to control bleeding and improve visibility in the surgical field. Recent evidence has thrown into question the routine use of tourniquets in the adult population resulting in a British Orthopaedic Association standard for intraoperative use. This systematic review evaluates the evidence on the practice, benefits, and risks of the intraoperative use of tourniquets for trauma and elective orthopaedic surgery in the paediatric population. Methods: A prospectively registered systematic review was conducted using the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines (PROSPERO: CRD42022359048). A search of MEDLINE, Embase, the Cochrane Library and a Grey literature search was performed from their earliest record to 23 March 2023. Studies reporting tourniquet data in paediatric patients undergoing orthopaedic surgery were included. Data extracted included demographics, involved limb, trauma versus elective use, tourniquet use as primary or secondary measure, and tourniquet parameters and complications. Results: Thirty-nine studies were included. Tourniquet practices and information reporting varied considerably. Tourniquets were used uneventfully in the majority of patients with no specific benefits reported. Several physiological and biochemical changes as well as complications including nerve injury, compartment syndrome, skin burns, thrombosis, post-operative limb swelling, and pain were reported. Conclusions: Tourniquets are routinely used in both trauma and elective paediatric orthopaedic surgery with no high-quality research affirming benefits. Severe complications associated with their use are rare but do occur. High-quality studies addressing their benefits, the exact indication in children, and the safest way to use them in this population are necessary.

A 'Hub and Spoke' Shared Care initiative for CTEV Ponseti service.

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). Results: Between 1 March 2020 and 31 March 2023, 92 patients (139 feet) were treated at the service (Hub 50%, n = 46; Spokes 50%, n = 46), of whom nine were non-idiopathic. All patients (n = 92), regardless of allocation, ultimately achieved primary correction, with idiopathic patients at the Hub requiring fewer casts than the Spokes (mean 4.0 (SD 1.4) vs 6.9 (SD 4.4); p < 0.001). Overall, 60.9% of Spokes' patients (n = 28/46) required transfer to the Hub due to complications (cast slips Hub n = 2; Spokes n = 17; p < 0.001). These patients ultimately achieved full correction at the Hub. Conclusion: The Shared Care model was found to be feasible in terms of providing primary correction to all patients, with results comparable to other published services. Complication rates were higher at the Spokes, although these were correctable. Future research is needed to assess long-term outcomes, parents' satisfaction, and cost-effectiveness.

Preoperative vascular assessment of patients with a supracondylar humeral fracture and a perfused, pulseless limb.

The 'pink, pulseless hand' is often used to describe the clinical situation in which a child with a supracondylar fracture of the humerus has normal distal perfusion in the absence of a palpable peripheral pulse. The management guidelines are based on the assessment of perfusion, which is difficult to undertake and poorly evaluated objectively. The aim of this study was to review the available literature in order to explore the techniques available for the preoperative clinical assessment of perfusion in these patients and to evaluate the clinical implications. A systematic literature review was conducted using the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines and registered prospectively with the International Prospective Register of Systematic Reviews. Databases were explored in June 2022 with the search terms (pulseless OR dysvascular OR ischaemic OR perfused OR vascular injury) AND supracondylar AND (fracture OR fractures). A total of 573 papers were identified as being suitable for further study, and 25 met the inclusion criteria for detailed analysis. These studies included a total of 504 patients with a perfused, pulseless limb associated with a supracondylar humeral fracture. Clinical examination included skin colour (23 studies (92%)), temperature (16 studies (64%)), and capillary refill time (13 studies (52%)). Other investigations included peripheral oxygen saturation (SaO2) (six studies (24%)), ultrasound (US) (14 (56%)), and CT angiogram (two studies (8.0%)). The parameters of 'normal perfusion' were often not objectively defined. The time to surgery ranged from 1.5 to 12 hours. A total of 412 patients (82%) were definitively treated with closed or open reduction and fixation, and 92 (18%) required vascular intervention, ranging from simple release of entrapped vessels to vascular grafts. The description of the vascular assessment of the patient with a supracondylar humeral fracture and a pulseless limb in the literature is variable, with few objective criteria being used to define perfusion. The evidence base for decision-making is limited, and further research is required. We were able, however, to make some recommendations about objective criteria for the assessment of these patients, and we suggest that these are performed frequently to allow the detection of any deterioration of perfusion.

Development of a core outcome set for the orthopaedic management of spinal dysraphism : a study protocol.

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 COS for orthopaedic management in SD will enable meaningful reporting and facilitate comparisons in future clinical trials, thereby assisting complex decision-making in the clinical management of these children. Cite this article: Bone Jt Open 2022;3(1):54-60.

The outcomes of idiopathic congenital talipes equinovarus : a core outcome set for research and treatment.

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.

Percutaneous Achilles tenotomy under local anaesthetic in the clubfoot clinic was safe during the COVID-19 pandemic, for both children and parents.

PURPOSE: An Achilles tenotomy is routinely required to correct the equinus deformity in Congenital talipes equinovarus (CTEV) patients as part of the gold standard treatment using the Ponseti method. This procedure can be performed in clinic under local anaesthetic or in theatre under general anaesthetic. The COVID-19 pandemic reduced theatre capacity and caused a delay to CTEV patients' treatment. A new standard operating procedure that allowed the tenotomies to be performed under local anaesthetic in the clinic was introduced. This study was looking into the safety, feasibility and parents' perspective of this procedure. METHODS: The study was prospectively registered as a service improvement project and followed the SQUIRE guidelines (Ogrinc et al. in BMJ Qual Saf 25:986-992, 2016). All consecutive patients requiring a tenotomy were included. Data was collected prospectively including demographics, Pirani score and a carers' satisfaction questionnaire. RESULTS: Twenty five patients (36 tenotomies) were included in the study. The median age was 9 weeks. All patients achieved ankle dorsiflexion of greater than 15° post-op. None of the patients nor their parents contracted the COVID 19 virus. All parents reported a positive experience and 99% felt less anxious about having the tenotomy done in clinic rather than theatre. CONCLUSIONS: The new service offering clinic tenotomies was found to be safe and clinically successful. This study is the first to show parents preference and excellent satisfaction with a tenotomy performed under local anaesthetic. The service has improved the allocation of resources and due to its success, will continue beyond the pandemic.

Subtalar arthroereisis for the treatment of the symptomatic paediatric flexible pes planus: a systematic review.

Subtalar arthroereisis has a controversial history and has previously been associated with high failure rates and excessive complications.A database search for outcomes of arthroereisis for the treatment of symptomatic paediatric flexible pes planus provided 24 articles which were included in this review, with a total of 2550 feet operated on.Post-operative patient-reported outcome measures recorded marked improvement. Patient satisfaction was reported as excellent in 79.9%, and poor in 5.3%. All radiological measurements demonstrated improvement towards the normal range following arthroereisis, as did hindfoot valgus, supination, dorsiflexion and Viladot grade.Complications were reported in 7.1% of cases, with a reoperation rate of 3.1%.Arthroereisis as a treatment for symptomatic paediatric flexible pes planus produces favourable outcomes and high patient satisfaction rates with a reasonable risk profile. There is still a great deal of negativity and literature highlighting the complications and failures of arthroereisis, especially for older implants.The biggest flaws in the collective literature are the lack of high-quality prospective studies, a paucity of long-term data and the heterogeneity of utilized outcome measures between studies. Cite this article: EFORT Open Rev 2021;6:118-129. DOI: 10.1302/2058-5241.6.200076.

Development of a core outcome set for idiopathic clubfoot management.

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.

Quality of outcome data in total hip arthroplasty: comparison of registry data and worldwide non-registry studies from 5 decades.

PURPOSE: This systematic review assessed evidence on outcome (revision rate for all reasons) following hip arthroplasty from its beginning 5 decades ago. METHODS: We evaluated all studies from all current hip implants since their market introduction in 1962 regarding "revision rate per 100 observed component years". Data were compared with arthroplasty registries. RESULTS: A total of 54 different hip implants were included: for 81% (44 of 54) data is either absent or poor; for 30% (16 of 54) not a single publication could be found. For 52% (28 of 54) less than 100 revisions for all reasons are published in non-registry studies. The remaining 10 implants (19%) comprise 92638 primary implants with 4473 revisions. Control group were the same implants with 111658 primary cases and 3029 revisions from arthroplasty registries. A systematic developer bias as in knee arthroplasty could not be found but several independent authors were found to significantly bias the literature. The overall revision rates per 100 observed component years from non-registry studies (and joint registries) are 0.4 (0.5) for stems, 0.7 (0.7) for cups and 1.4 (2.1) for resurfacing systems. CONCLUSIONS: For 81% of all hip implants assessed limited evidence exists from non-registry studies regarding outcome (revision rate) even 5 decades after market introduction. For the remaining 19% of implants no systematic developer bias could be found but several individual authors significantly biased results of single implants. We therefore ask for a more active publication of new implants.

Infection following hip replacement: solution options.

The key to the optimal management of an acutely infected arthroplasty is an expeditious diagnosis with careful assessment of the mode of presentation and treatment variables to determine the appropriate management strategy. At our institution acute infection is managed early and aggressively with debridement and exchange of mobile parts and change of the implant if it is cementless. For established chronic infection, each case is considered individually, using single-stage exchange in selected circumstances (1 in 6 cases). Two-stage exchange with an articulating spacer is used in the remainder. Single-stage revision offers clinical and economic advantages over a two-stage revision in selected patients, and although ongoing evaluation is still in place, currently we have had no reinfections in our single-stage revision cohort.