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The Bone & Joint Journal
Vol. 106-B, Issue 12 | Pages 1408 - 1415
1 Dec 2024
Wall L Bunzli S Nelson E Hawke LJ Genie M Hinwood M Lang D Dowsey MM Clarke P Choong PF Balogh ZJ Lohmander LS Paolucci F

Aims. Surgeon and patient reluctance to participate are potential significant barriers to conducting placebo-controlled trials of orthopaedic surgery. Understanding the preferences of orthopaedic surgeons and patients regarding the design of randomized placebo-controlled trials (RCT-Ps) of knee procedures can help to identify what RCT-P features will lead to the greatest participation. This information could inform future trial designs and feasibility assessments. Methods. This study used two discrete choice experiments (DCEs) to determine which features of RCT-Ps of knee procedures influence surgeon and patient participation. A mixed-methods approach informed the DCE development. The DCEs were analyzed with a baseline category multinomial logit model. Results. The proportion of respondents (surgeons n = 103; patients n = 140) who would not participate in any of the DCE choice sets (surgeons = 31%; patients = 40%), and the proportion who would participate in all (surgeons = 18%; patients = 30%), indicated strong views regarding the conduct of RCT-Ps. There were three main findings: for both surgeons and patients, studies which involved an arthroscopic procedure were more likely to result in participation than those with a total knee arthroplasty; as the age (for patients) and years of experience (for surgeons) increased, the overall likelihood of participation decreased; and, for surgeons, offering authorship and input into the RCT-P design was preferred for less experienced surgeons, while only completing the procedure was preferred by more experienced surgeons. Conclusion. Patients and surgeons have strong views regarding participation in RCT-Ps. However, understanding their preferences can inform future trial designs and feasibility assessments with regard to recruitment rates. Cite this article: Bone Joint J 2024;106-B(12):1408–1415


Orthopaedic Proceedings
Vol. 102-B, Issue SUPP_6 | Pages 108 - 108
1 Jul 2020
Chang J Bhanot K Grant S Fecteau A Camp M
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The process of obtaining informed consent is an important and complex pursuit, especially within a paediatric setting. Medical governing bodies have stated that the role of the trainee surgeon must be explained to patients and their families during the consent process. Despite this, attitudes and practices of surgeons and their trainees regarding disclosure of the trainee's participation during the consent process has not been reported in the paediatric setting. Nineteen face-to-face interviews were conducted with surgical trainees and staff surgeons at a tertiary level paediatric hospital in Toronto, Canada. These were transcribed and subsequently thematically coded by three reviewers. Five main themes were identified from the interviews. 1) Surgeons do not consistently disclose the role of surgical trainees to parents. 2) Surgical trainees are purposefully vague in disclosing their role during the consent discussion without being misleading. 3) Surgeons and surgical trainees believe parents do not fully understand the specific role of surgical trainees. 4) Graduated responsibility is an important aspect of training surgeons. 5) Surgeons feel a responsibility towards both their patients and their trainees. Surgeons don't explicitly inform patients about the involvement of trainees, believing there is a lack of understanding of the training process. Trainee perspectives reflect this, with the view that families are aware of their participation but likely underestimate their role, and suggest that information is kept purposely vague to reduce anxiety. The majority of surgeons and surgical trainees do not voluntarily disclose the degree of trainee participation in surgery during the informed consent discussion with parents. An open and honest discussion should occur, allowing for parents to make an informed decision regarding their child's care. Further patient education regarding trainees' roles would help develop a more thorough and patient centred informed consent process


The Bone & Joint Journal
Vol. 96-B, Issue 8 | Pages 1041 - 1046
1 Aug 2014
Ollivier M Frey S Parratte S Flecher X Argenson JN

There is little in the literature on the level of participation in sports which patients undertake after total hip replacement (THR). Our aims in this study were to determine first, the level of sporting activity, second, the predictive factors for returning to sporting activity, and third, the correlation between participation in sports and satisfaction after THR. We retrospectively identified 815 patients who had undergone THR between 1995 and 2005. All were asked to complete a self-administered questionnaire regarding their sporting activity. A total of 571 patients (71%) met the inclusion criteria and completed the evaluation. At a mean follow-up of 9.8 years (. sd. 2.9), 366 patients (64%) returned to sporting activity as defined by a University of California at Los Angeles (UCLA) score of > 5. The main reasons that patients had for refraining from sports were fear of dislocation (65; 31.6%), avoiding wear (52; 25.4%), and the recommendation of the surgeon (34; 16.6%). There was a significant relationship between higher post-operative participation in sport in those patients with a higher pre-operative Harris hip score (HHS) (p = 0.0074), motivation to participate in sporting activities (p = 0.00022) and a shorter duration of symptoms (p = 0.0034). Finally, there was a correlation between age (p = 0.00013), UCLA score (p = 0.012) and pre-operative HHS (p = 0.00091) and satisfaction. In conclusion, we found that most patients participate in sporting activity after THR, regardless of the advice of their surgeon, and that there is a correlation between the level of participation and pre-operative function, motivation, duration of symptoms and post-operative satisfaction. Cite this article: Bone Joint J 2014;96-B:1041–6


The Bone & Joint Journal
Vol. 96-B, Issue 3 | Pages 332 - 338
1 Mar 2014
Dawson J Beard DJ McKibbin H Harris K Jenkinson C Price AJ

The primary aim of this study was to develop a patient-reported Activity & Participation Questionnaire (the OKS-APQ) to supplement the Oxford knee score, in order to assess higher levels of activity and participation. The generation of items for the questionnaire involved interviews with 26 patients. Psychometric analysis (exploratory and confirmatory factor analysis and Rasch analysis) guided the reduction of items and the generation of a scale within a prospective study of 122 relatively young patients (mean age 61.5 years (42 to 71)) prior to knee replacement. A total of 99, completed pre-operative and six month post-operative assessments (new items, OKS, Short-Form 36 and American Knee Society Score). The eight-item OKS-APQ scale is unidimensional, reliable (Cronbach’s alpha 0.85; intraclass correlation coefficient (ICC) 0.79; or 0.92 when one outlier was excluded), valid (r >  0.5 with related scales) and responsive (effect size 4.16). We recommend that it is used with the OKS with adults of all ages when further detail regarding the levels of activity and participation of a patient is required. Cite this article: Bone Joint J 2014;96-B:332–8


Orthopaedic Proceedings
Vol. 95-B, Issue SUPP_17 | Pages 23 - 23
1 Apr 2013
McCluskey S Brooks J King N Burton K
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Background. Individual illness perceptions have been shown to be important influences on both clinical and work outcomes for those with back pain, yet the influence of ‘significant others’ (spouse/partner/close family member) illness perceptions is rarely explored, particularly in relation to work participation. Method. Semi-structured interviews based on the Illness Perceptions Questionnaire were conducted with two purposive samples of chronic back pain patients (working and work disabled), along with their significant others (n=28). Data were analysed using template analysis. Results. The significant others of patients who were work disabled tended to reinforce the patients' limitations and negative consequences of the back pain condition on every aspect of their lives. They believed that patients needed to be pain-free in order to resume work, and equated treatment success with complete removal of pain. Overall, they perceived patients to be blameless victims. In contrast, the significant others of patients who had managed to remain at work despite persistent back pain focused instead on what the patient could still do, were more accepting of treatment as providing pain management rather than a cure, and tended to describe patients as being stoical and heroic. Conclusions. This exploratory in-depth research reveals novel and interesting insights about the illness beliefs of significant others in relation to persistent back pain, and highlights the wider social circumstances that may act as barriers/facilitators to work participation. No conflicts of interest. Sources of funding: BackCare and the BUPA foundation. This abstract has not been previously published in whole or substantial part nor has been presented previously at a national meeting


Orthopaedic Proceedings
Vol. 100-B, Issue SUPP_14 | Pages 23 - 23
1 Nov 2018
Grant S Chang J Bhanot K Camp M
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The process of gaining informed consent can be a complex and much debated pursuit, especially within a paediatric setting. The role of the trainee surgeon and its explanation to children and their families prior to an operation has not been explored from the resident surgeons' point of view. Ten face-to-face interviews were conducted with orthopaedic surgery trainees at a tertiary level paediatric hospital in Toronto, Canada. These were transcribed and subsequently thematically coded by 3 reviewers. Three main themes were identified from the interviews. 1) Surgical trainees feel their level of participation and autonomy gradually increases dependent on their observed skills and level of training. 2) Trainees feel the consent process is adequate but acknowledge it is often purposely vague with regards to their intra-operative involvement as this is often unpredictable and it avoids patient/family anxiety. 3) Trainees believe families are aware of their participation however most likely underestimate their role during operations. Trainees in surgical specialties believe their level of autonomy is variable dependent on a number of factors and that this impacts on the ability to be more specific when gaining informed consent. This must be balanced with a family's right to an appropriate understanding of their child's operation and who is performing it. It may be that further patient education regarding trainees and their role in operations would help develop a more thorough and patient centred informed consent process


Orthopaedic Proceedings
Vol. 99-B, Issue SUPP_4 | Pages 90 - 90
1 Feb 2017
Levy J Kurowicki J Law T Rosas S
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Background. Both anatomic (TSA) and reverse shoulder arthroplasty (RSA) are routinely performed for patients whom desire to continue to work or participate in sports. The purpose of this study is to analyze and compare the ability of patients to work and participate in sports based on responses to clinical outcome surveys. Methods. A retrospective review of 335 patients treated with TSA (179 patients) and RSA (156 patients) who completed questions 9 and 10 on the activity patient self-evaluation portion of the American Shoulder and Elbow Surgeons (ASES) Assessment Form was performed at average 30 months follow-up. Comparisons were made between TSA and RSA for the specific ASES score (rated 0–3) reported for usual work and sport, as well as ASES total score. Sports were subdivided based on those that predominantly use shoulder function. Results. Patients treated with TSA had a 32% greater ability to participate in sports (average specific ASES score 2.5 vs 1.9, p=0.001), with significantly higher scores for aquatic and sedentary sports (Figure 1). TSA patients demonstrated greater ability to participate in sports requiring shoulder function without difficulty, as 62% reported maximal scores (p=0.001) (Figure 2). TSA patients also demonstrated a 21% greater ability to perform work (average specific ASES score 2.6 vs. 2.1, p=0.001), with significantly higher scores for housework and gardening (Figure 3). Conclusion. Both TSA and RSA allow for participation in work and sport, with TSA patients reporting better overall ability to participate. For sports involving shoulder function, TSA patients more commonly report maximal ability to participate than RSA patients


Orthopaedic Proceedings
Vol. 94-B, Issue SUPP_I | Pages 3 - 3
1 Jan 2012
Franz C Jespersen E Junge T Christiansen C Klakk H Heidemann M Leboeuf-Yde C Wedderkopp N
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Background. There is concern that a sedentary lifestyle in childhood is harmful to spinal health. The literature stands divided, as there are reports also of an increased injury rate in children who are physically active. Children cannot be expected to remember correctly amount of physical activity in the past nor can they remember correctly past events of backpain. We therefore used a new method, SMS-Track, to collect weekly data over a long period of time. Methods and material. In a prospective Danish study, the effect of increased physical activity was tested vs. “business-as-usual” in 10 primary schools. We collected data on time spent on physical activities and any backpain in the preceding week. For this we sent the children weekly text-messages, to which the children/parents responded with a text-message as well. If the child reported having had any backpain during the preceding week, the parents were contacted, the child seen by a health professional, and treatment initiated if necessary. Results. Compliance for responding to the text-messages was 92%. The total risk time was 35,238 weeks for the participating 1208 children. As the assumption for proportional hazards was not met, negative binomial regression was used to test the association between level of physical activity and incidence of backpain. In addition, we adjusted for age, school and grade level and used robust standard errors. Adjustment for clustering in the school classes was also made. Sport participation reduced the incidence rate significantly with 0.08 for each day with organised sport after school. Conclusion. These interim analyses indicate that sport participation is protective, reducing the risk of reporting backpain in childhood


Orthopaedic Proceedings
Vol. 104-B, Issue SUPP_7 | Pages 80 - 80
1 Jul 2022
Pinheiro VH Jones M Borque K Balendra G White N Ball S Williams A
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Abstract

Introduction

Elite athletes sustaining a graft re-rupture after ACL reconstruction (ACL-R) undergo revision reconstruction to enable their return to elite sport. The aim of this study was to determine the rate of return to play (RTP) and competition levels at 2 and 5 years post revision ACL-R.

Methodology

A consecutive series of revision ACL-R in elite athletes undertaken by the senior author between 2009 and 2019 was retrospectively reviewed. Outcome measures were RTP rates and competition level.


Bone & Joint 360
Vol. 7, Issue 6 | Pages 1 - 1
1 Dec 2018
Ollivere B


Orthopaedic Proceedings
Vol. 98-B, Issue SUPP_3 | Pages 92 - 92
1 Jan 2016
Noble P Noel C
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INTRODUCTION

The timely identification of outliers (implants, surgeons or patients) using prospectively collected registry data is confounded by many factors, including the assumption that the sampled population is representative of the entire cohort of patients. In this study we utilized a computer simulation of a joint registry to address the question: How does incomplete enrollment of patients in registries affect the reliability of identification of outliers, and what percent capture of the target population is sufficient?

MATERIALS AND METHODS

A synthetic registry was created consisting of 10,000 patients (100 surgeons), of whom, 1000 underwent joint replacement using a new implant. A predictive model for the risk of revision was created from data published by the Swedish TKR Registry and the AOANJRR. The pairing of patients, surgeons and implants was randomized and for each assignment, the probability of revision was computed. We then chose random samples of all patients in 10% increments from 10% to 100%, simulating incomplete capture of all potential cases by the registry. For each sample we calculated the number of cases of the new implant predicted to end in revision. The assignments were repeated 2000 times using implants with revision rates of 1.5%, 2.0% and 3.0% per annum vs. 1.0% for all other implants of the same class.


Orthopaedic Proceedings
Vol. 95-B, Issue SUPP_13 | Pages 72 - 72
1 Mar 2013
Akilapa O Prem H
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Background

Surgical resection of middle facet tarsal coalition is a well documented treatment option in symptomatic individuals that do not respond to conservative treatment. The ability to return to full recreational activity post resection may have implications on foot biomechanics and possibly degenerative changes in the subtalar and adjacent joints.

Hypothesis

Open resection of middle facet tarsal coalitions should improve subtalar joint motion and biomechanical function and facilitate return to sports.


Orthopaedic Proceedings
Vol. 86-B, Issue SUPP_II | Pages 157 - 157
1 Feb 2004
Skoura E Voudiklaris N Blatsoukas K Iliakis E Andreakos A
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Aim of the study: The goal of this survey is to demonstrate the extent of disability, caused by these accidents.

Patients and methods: In the year 2001, 317 patients with skeletal injuries, aged between 19 – 65, were examined by the first degree health committee of the 1st clinic of orthopaedics, of the 1st I.K.A hospital.

The three – member committee reviewed the patients according to certain protocol, based on descriptive criteria such as: the location and severeness of the injury, the treatment suggested and the time off work.

Results: Skeletal lesions, due to road – traffic and industrial accidents were 29.34% and 13.56% respectively.

Road – traffic accident victims who suffered multiple fractures were 18.56%. Among them, the age group between 21–25 years was involved in 38.88% of the cases, while the age group between 26–30 years, in 16.66%.

Patients who suffered multiple fractures in industrial accidents were 5.36% of the cases. 66.66% of them were aged between 36–40 years.

In the total of patients with non – multiple fractures, those who suffered fractures in the upper and in the lower extremities were 22.7% and 77.3% respectively.

In detail (in the total of fractures): Spinal fractures 9.1%, pelvic fractures 2.8%, femoral neck and inter-trochanteric fractures 4.41%, femoral fractures 11.04%. Tibial fractures were 29.65% and fractures of the foot 20.18%.

Tibial fractures occurred in road – traffic accidents were 29.78% in the total of tibial fractures and 30.10% in the total of fractures sustained in traffic accidents.

Tibial fractures occurred in industrial accidents were 7.44% in the total of tibial fractures and 16.27% in the total of fractures sustained in industrial accidents.

Femoral fractures due to traffic accidents, involved 62.85% of the total of femoral fractures and 23.65% of the total of the fractures sustained in road – traffic accidents.

Femoral fractures due to industrial accidents, involved 14.28% of the total of femoral fractures and 11.62% of the total of the fractures sustained in industrial accidents.

In the total of spinal fractures, traffic and industrial accidents had an equal distribution.

All pelvic fractures took place in road – traffic accidents.

As to how long the patients were unable to return to work, we recorded the following:

In the group of patients with multiple fractures sustained in traffic accidents, 94.4% returned to their work after about 6 months, 72.2% after 6 to 12 months and 33.3% after more than a year.

All the multiple – fractured patients who suffered industrial accidents returned to work after at least 1 year, while 66.6% of them had to stay out of work even longer.

Patients with tibial fractures stayed out of work: 31.5% of traffic and 100% of industrial accidents for over 6 months, while 10.5% of traffic and 33.3% of industrial accidents for over a year.

Patients with femoral fractures stayed out of work for over 6 months in 66.6% of traffic and 100% of industrial accidents.

Conclusions: It is clear that there is a high incidence of lower extremities fractures (more frequently taking place during road-traffic and industrial accidents), especially between the ages of 21–30 years.

Full recovery of patients and consequently their return to work, was slow and directly associated with the type and location of the fracture they sustained, and the severeness of the injury they had initially suffered, resulting to a very high cost for public health organizations.


Orthopaedic Proceedings
Vol. 105-B, Issue SUPP_7 | Pages 1 - 1
4 Apr 2023
Buldu M Sacchetti F Yasen A Furtado S Parisi V Gerrand C
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Primary malignant bone and soft tissue tumours often occur in the lower extremities of active individuals including children, teenagers and young adults. Survivors routinely face long-term physical disability. Participation in sports is particularly important for active young people but the impact of sarcoma treatment is not widely recognised and clinicians may be unable to provide objective advice about returning to sports. We aimed to identify and summarise the current evidence for involvement in sports following treatment of lower limb primary malignant bone and soft tissue tumours. A comprehensive search strategy was used to identify relevant studies combining the main concepts of interest: (1) Bone/Soft Tissue Tumour, (2) Lower Limb, (3) Surgical Interventions and (4) Sports. Studies were selected according to eligibility criteria with the consensus of three authors. Customised data extraction and quality assessment tools were used. 22 studies were selected, published between 1985 – 2020, and comprising 1005 patients. Fifteen studies with data on return to sports including 705 participants of which 412 (58.4%) returned to some form of sport at a mean follow-up period of 7.6 years. Four studies directly compared limb sparing and amputation; none of these were able to identify a difference in sports participation or ability. Return to sports is important for patients treated for musculoskeletal tumours, however, there is insufficient published research to provide good information and support for patients. Future prospective studies are needed to collect better pre and post-treatment data at multiple time intervals and validated clinical and patient sports participation outcomes such as type of sports participation, level and frequency and a validated sports specific outcome score, such as UCLA assessment. In particular, more comparison between limb sparing and amputation would be welcome


Bone & Joint Open
Vol. 2, Issue 12 | Pages 1043 - 1048
1 Dec 2021

Aims. There is limited information on outcomes of revision ACL reconstruction (rACLR) in soccer (association football) athletes, particularly on return to sport and the rate of additional knee surgery. The purpose of this study was to report return to soccer after rACLR, and to test the hypothesis that patient sex and graft choice are associated with return to play and the likelihood of future knee surgery in soccer players undergoing rACLR. Methods. Soccer athletes enrolled in a prospective multicentre cohort were contacted to collect ancillary data on their participation in soccer and their return to play following rACLR. Information regarding if and when they returned to play and their current playing status was recorded. If they were not currently playing soccer, they were asked the primary reason they stopped playing. Information on any subsequent knee surgery following their index rACLR was also collected. Player demographic data and graft choice were collected from their baseline enrolment data at rACLR. Results. Soccer-specific follow-up was collected on 76% (33 male, 39 female) of 95 soccer athletes. Subsequent surgery information was collected on 95% (44 male, 46 female). Overall, 63% of athletes returned to soccer a mean 9.6 months (SD 5.8) after index revision surgery but participation in soccer decreased to 19% at a mean of 6.4 years (SD 1.3) after surgery. There was no significant association of patient sex or graft choice with return to play, time of return to play, or long-term return to play. Females were more likely than males to have subsequent knee surgery following rACLR (20% (9/46) vs 5% (2/44); p = 0.050). The rate of recurrent graft tear (5.6%; 5/90) was similar between males and females. Conclusion. Approximately two-thirds of soccer players return to sport after rACLR, but the rate of participation drops significantly over time. Neither patient sex nor graft choice at the time of rACLR were associated with return to play. Female soccer players face a higher risk for additional knee surgery after rACLR than male soccer players. Cite this article: Bone Jt Open 2021;2(12):1043–1048


Bone & Joint 360
Vol. 12, Issue 2 | Pages 39 - 42
1 Apr 2023

The April 2023 Children’s orthopaedics Roundup. 360. looks at: Can you treat type IIA supracondylar humerus fractures conservatively?; Bone bruising and anterior cruciate ligament injury in paediatrics; Participation and motor abilities after treatment with the Ponseti method; Does fellowship training help with paediatric supracondylar fractures?; Supracondylar elbow fracture management (Supra Man): a national trainee collaborative evaluation of practice; Magnetically controlled growing rods in early-onset scoliosis; Weightbearing restrictions and weight gain in children with Perthes’ disease?; Injuries and child abuse increase during the pandemic over 12,942 emergency admissions


Orthopaedic Proceedings
Vol. 106-B, Issue SUPP_18 | Pages 93 - 93
14 Nov 2024
Tønning L Jakobsen SS Kemp J O’Brien M Dalgas U Mechlenburg I
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Introduction. Symptomatic hip dysplasia is often treated with periacetabular osteotomy (PAO). Studies investigating the effect of PAO have primarily focused on radiographic measurements, pain-related outcomes, and hip survival whereas evidence related to sport participation is limited. Methods. All patients in our institutional database were deemed eligible for this cohort study if they underwent PAO and had answered at least one question related to sport participation. Patients were asked if they were playing sport preoperatively, 6 months after PAO as well as 2, 5, 10, 15 and 20 years after. In addition, patients were asked if they were able to play their preferred sport, what type and at what level they were playing sport, and if surgery had improved their sport performance. Results. Among 2398 patients surveyed, 1926 (80%) were included and 56% were playing sport 6 months after PAO. This number was 61% two years after PAO, and remained around that for the following years, before dropping 15 years after PAO. Between 56% and 71% of patients felt that their sporting performance improved following PAO at the different time points. Between 39% (6 months after PAO) and 63% (15 years after PAO) were able to participate in their preferred sport. Conclusion. The majority of patients undergoing PAO due to hip dysplasia will return to, and maintain, sport after PAO. More than half of patients undergoing PAO believe that the surgery improved their sports performance, and long after the surgery more than half of patients undergoing PAO are able to play their preferred sport


Orthopaedic Proceedings
Vol. 106-B, Issue SUPP_6 | Pages 57 - 57
2 May 2024
Martin A Alsousou J Chou D Costa M Carrothers A
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Current treatment options for displaced acetabular fractures in elderly patients include non-surgical management, surgical fixation and surgical fixation with simultaneous hip replacement, the so-called “fix-and-replace”™. There remains a paucity of evidence to guide surgeons in decision making for these difficult injuries. The aim of this study was to assess the feasibility of performing an appropriately powered RCT between treatment options for acetabular fractures in older patients. This was an NIHR funded feasibility triple-arm RCT with participation from 7 NHS MTCs. Patients older than 60 were recruited if they had an acetabular fracture deemed sufficiently displaced for the treating surgeon to consider surgical fixation. Randomisation was performed on a 1:1:1 basis. The three treatment arms were non-surgical management, surgical fixation and fix-and-replace. Feasibility was assessed by willingness of patients to participate and clinicians to recruit, drop out rate, estimates of standard deviation to inform the sample size calculation for the full trial and completion rates to inform design of a future definitive trial. EQ-5D was the primary outcome measure at 6 months, OHS and Disability Rating Index were secondary outcome measures. Of 117 eligible patients, 60 were randomised whilst 50 declined study participation. Nine patients did not receive their allocated intervention. Analysis was performed on an intention to treat basis. During the study period 4 patients withdrew before final review, 4 patients died and 1 was lost to follow-up. The estimated sample size for a full scale study was calculated to be 1474 participants for an EQ-5D MCID of 0.06 with a power of 0.8. This feasibility study suggests a full scale trial would require international collaboration. This study also has provided observed safety data regarding mortality and morbidity for the fix-and-replace procedure to aid surgeons in the decision-making process when considering treatment options


Bone & Joint Open
Vol. 2, Issue 8 | Pages 631 - 637
10 Aug 2021
Realpe AX Blackstone J Griffin DR Bing AJF Karski M Milner SA Siddique M Goldberg A

Aims. A multicentre, randomized, clinician-led, pragmatic, parallel-group orthopaedic trial of two surgical procedures was set up to obtain high-quality evidence of effectiveness. However, the trial faced recruitment challenges and struggled to maintain recruitment rates over 30%, although this is not unusual for surgical trials. We conducted a qualitative study with the aim of gathering information about recruitment practices to identify barriers to patient consent and participation to an orthopaedic trial. Methods. We collected 11 audio recordings of recruitment appointments and interviews of research team members (principal investigators and research nurses) from five hospitals involved in recruitment to an orthopaedic trial. We analyzed the qualitative data sets thematically with the aim of identifying aspects of informed consent and information provision that was either unclear, disrupted, or hindered trial recruitment. Results. Recruiters faced four common obstacles when recruiting to a surgical orthopaedic trial: patient preferences for an intervention; a complex recruitment pathway; various logistical issues; and conflicting views on equipoise. Clinicians expressed concerns that the trial may not show significant differences in the treatments, validating their equipoise. However, they experienced role conflicts due to their own preference and perceived patient preference for an intervention arm. Conclusion. This study provided initial information about barriers to recruitment to an orthopaedic randomized controlled trial. We shared these findings in an all-site investigators’ meeting and encouraged researchers to find solutions to identified barriers; this led to the successful completion of recruitment. Complex trials may benefit for using of a mixed-methods approach to mitigate against recruitment failure, and to improve patient participation and informed consent. Cite this article: Bone Jt Open 2021;2(8):631–637


Introduction. At Sheffield Children's Hospital, treatment of leg length discrepancy is a common procedure. Historically, this has been done with external fixators. With the development in intramedullary technology, internal nails have become the preferred modality for long bone lengthening in the adolescent population. However, it is important to review whether this technology practically reduces the known challenges seen and if it brings any new issues. Therefore, the aim of this review is to retrospectively evaluate the therapeutic challenges of 16 fit-bone intramedullary femoral lengthening's at Sheffield Children's Hospital between 2021–2022. Materials & Methods. The international classification of function (ICF) framework was used to differentiate outcomes. The patient's therapy notes were retrospectively reviewed for themes around structural, activity and participation limitation. The findings were grouped for analysis and the main themes presented. Results. There were 8 males, mean age 17.4 years (range 17–18) and 8 females, mean age 15.9 years (range 14–18). 5 right and 11 left femurs were lengthened. Underlying pathology varied amongst the 16 patients. All patients went into a hinged knee brace post operatively. Structural limitations included: pain, fixed flexion deformity of the knee, loss of knee flexion, quadriceps muscle lag, muscle spasms and gluteal weakness. The primary activity limitation was reduced weight bearing with altered gait pattern. Participation limitations included reduced school attendance and involvement in activities with peers. Access to Physiotherapy from local services varied dramatically. Five of the cohort have completed treatment. Conclusions. Anecdotally, intramedullary femoral lengthening nails have perceived benefits for families compared to external fixators in the adolescent population. However, there remain musculoskeletal and psychosocial outcomes requiring therapeutic management throughout the lengthening process and beyond. Therefore, quantifying these outcomes is essential for measuring the impact on each patient for comparison. To interpret these themes, we need to evaluate the outcomes objectively, this was not done consistently in this review. Future research should look at outcome measures that are sensitive to all aspects of the ICF. With an aim of improving the therapeutic treatment provided and the overall outcome for the children treated