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Orthopaedic Proceedings
Vol. 105-B, Issue SUPP_3 | Pages 63 - 63
23 Feb 2023
Tan R Jadresic M Baker J
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Māori consistently have poorer health outcomes compared to non-Māori within Aotearoa. Numerous worldwide studies demonstrate that ethnic minorities receive less analgesia for acute pain management. We aimed to compare analgesic management of a common orthopaedic injury, tibial shaft fracture, between Māori and non-Māori. A retrospective cohort study from January 1. st. , 2015, to December 31. st. 2020 inclusive. Eligible patients were 16–65 years old and had isolated closed tibial shaft fractures. 104 patients were included in the study, 48 Māori and 56 Non-Māori. Baseline demographics were similar between the 2 cohorts. The primary outcome measure was type of analgesia charted on the ward. Secondary outcome measures were pre-hospital medications given, pain scores on arrival to the emergency department (ED) and the ward, time to analgesia in ED and type of analgesia given in ED. Statistics were calculated using Fisher's exact test, Pearson's chi-squared test or Wilcoxson's rank sum test as appropriate. No statistically significant differences were found in opiates or synthetics charted to Māori vs Non-Māori (83% vs 89% and 77% vs 88% respectively), opiates given in ED, time to analgesia in ED or ED and ward arrival pain scores. Of statistical significance is that Māori were less likely to receive pre-hospital medication compared to Non-Māori (54% vs 80% respectively, p=0.004). Māori were significantly less likely to receive pre-hospital pain medication compared to Non-Māori. However no other statistically significant findings were found when comparing pain scores, time to analgesia or type of pain relief charted for Māori vs non-Māori. The reasons for Māori receiving significantly less prehospital medication were not explored in this study and further investigation is required to reduce the bias that exists in this area


Orthopaedic Proceedings
Vol. 106-B, Issue SUPP_20 | Pages 4 - 4
12 Dec 2024
Santhanam SS Velayuthum S Palaniswamy G
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This randomized controlled study aimed to compare surgical duration, intra-operative blood loss, and fluoroscopy time between the suprapatellar and infrapatellar approaches for intramedullary interlocking nailing of tibia. We included 40 adult patients with tibial shaft fractures, excluding those with non-union, revision surgery, or polytrauma. Patients were divided equally into two groups using block randomization: Group A (20 patients) underwent the infrapatellar approach, and Group B (20 patients) underwent the suprapatellar approach. Blood loss was measured using gravimetric method and by changes in pre-operative and post operative haemoglobin levels. Surgical duration was estimated by calculating the time elapsed between the start and end of the procedure and fluoroscopy time was logged from the fluoroscopy machine. In group A, blood loss averaged 154±30.98ml, slightly more than in group B (150±32.92ml), though the difference was not statistically significant (p>0.05). Group A also showed a higher difference in haemoglobin levels (2.20±1.13 gm/dl) compared to group B (1.15±0.93 gm/dl), which was statistically significant (p=0.02). Fluoroscopy time and surgery duration were slightly longer in group A compared to group B but not statistically significant(p=0.693). The suprapatellar approach results in lesser blood loss, potentially promoting faster recovery, reduced need for blood transfusions and shorter hospital stays. It also entails shorter fluoroscopy time and surgical duration (though not statistically significant) which may reduce radiation exposure for the surgical team


Orthopaedic Proceedings
Vol. 105-B, Issue SUPP_15 | Pages 69 - 69
7 Nov 2023
Ward J Louw F Klopper S Schmieschek M
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Motorcycle accident-related traffic accidents contribute significantly to the burden of orthopaedic injuries seen in the South African Healthcare system. Subsequent to the Covid-19 pandemic, there has been an increase in the number of delivery drivers on the roads of South Africa. Many of these delivery drivers have no formal employment contracts. We aim to describe the demographics and injury patterns in motorcyclists involved in time dependent delivery work in South Africa; and to quantify the cost to the state of their orthopaedic surgeries. We performed a consecutive case series study at all of the hospitals draining the study region over the period of one year. Epidemiological, clinical and cost to hospital data was collected from medical records, digital radiographs, theatre invoices and a dedicated patient questionnaire. Provisional. So far 41 delivery drivers were captured by the study over a period of 11 months. All drivers were male and the vast majority foreign nationals. 11 patients were polytraumatised and 5 required admission to an intensive care unit. The most common injury patterns were closed femur fractures (17) followed by tibial shaft fractures (13). The average cost of surgery was R35 049 and average cost of ward stay R44 882 at an average of 10 days admission in a general ward. Overall, an estimated total of R 3.1 million rand was spent on these injuries. Informally employed “app users” performing delivery work on motorcycles in South Africa have added a significant burden to the cost of state healthcare since 2020. The vast majority of these patients are foreign nationals who do not hold South African licences or health insurance. They are sustaining high energy injuries typical of motorcycle-car accidents and many of them are left with lifelong loss of function


Orthopaedic Proceedings
Vol. 94-B, Issue SUPP_XXIII | Pages 208 - 208
1 May 2012
Tay W Gruen R Richardson M de Steiger R
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Delayed union and non-union are complications of fracture healing associated with pain and with functional and psychosocial disability. This study compares the effect on self-reported health outcomes of delayed union or non-union of femoral and tibial shaft fractures treated at two major metropolitan trauma centres in Victoria. Patients admitted to the Royal Melbourne Hospital and The Alfred with extra- articular femoral and tibial shaft fractures during 2003-2004 and 2005-2006, and followed up by the Victorian Orthopaedic Trauma Outcomes Registry (VOTOR) were included. Hospital medical records were reviewed to identify the outcome of each fracture. Fracture healing was assessed by the need for unplanned revision surgery for delayed union or nonunion, and clinical and radiological evidence of union. Prospectively-gathered VOTOR health outcome measurements included the Short Form 12-Item Health Survey (SF-12), and return to work and pain status at 6 and 12 months post injury. Of the 520 patients, 260 femoral and 282 tibial shaft fractures were included. In total, 285 fractures progressed to union, 138 fractures developed delayed union or non-union and 119 fractures had an unknown outcome. Factors that were significantly different between the union and delayed union or non-union groups included: fund source, mechanism of injury, other injuries, wound and Gustilo type, and fixation method. On linear regression modelling, an inverse relationship was demonstrated between delayed union or nonunion and the Physical and Mental Component Summary scores of the SF-12. This was statistically significant at both 6 and 12 months post injury unadjusted and adjusted for age, gender and other injuries. On logistic regression modelling, patients with delayed union or non-union showed unadjusted and adjusted risk ratios of 0.85 and 0.82, respectively at 6 months, and 0.82 and 0.76, respectively at 12 months to return to work. Similarly, patients with delayed union or nonunion had unadjusted and adjusted risk ratios of 1.09 and 1.11, respectively at 6 months, and 1.33 and 1.37, respectively at 12 months to have pain. Both were statistically significant at 12 months post injury unadjusted and adjusted for age, gender and other injuries. Patients with delayed union or non-union of femoral and tibial shaft fractures have poorer physical and mental health at 6 and 12 months post injury. In addition, they are less likely to have returned to work and more likely to still have pain at 12 months post injury


Orthopaedic Proceedings
Vol. 104-B, Issue SUPP_5 | Pages 39 - 39
1 Apr 2022
Patel K Galanis T Nie D Saini A Iliadis A Heidari N Vris A
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Introduction. Fracture related infections (FRI) following intramedullary nailing for tibial shaft fractures remain challenging to treat with associated high patient morbidity and healthcare costs. Recently, antibiotic-coated nails have been introduced as a strategy to reduce implant related infection rates in high-risk patients. We present the largest single-centre case series on ETN PROtect® outcomes reporting on fracture union, infection rates and treatment complications. Materials and Methods. 56 adult patients underwent surgery with ETN PROtect® between 01/09/17 and 31/12/20. Indications consisted of acute open fractures and complex revision cases (FRI, non-union surgery and re-fracture) with a mean of 3 prior surgical interventions. 51 patients had an open fracture as their index injury. We report on patient characteristics and outcomes including radiological/clinical union and deep infection. The one-year minimum follow-up rate was 87.5%. Results. One (1.8%) patient developed a deep surgical infection and associated non-union requiring further surgery. In addition, we identified three cases (5.4%) of aseptic non-union following facture treatment with ETN PROtect®. Of the 5 patients who underwent staged complex revision surgery for established FRI with ETN PROtect®, all had treatment failure with ongoing symptoms of deep infection requiring further treatment. Conclusions. Use of the ETN PROtect® nail in high-risk patients in the acute trauma setting demonstrates promising outcomes in the prevention of implant-related infection. In our limited series we have failed to observe any benefit over uncoated nails, when used in treating cases of established FRI/osteomyelitis and would therefore advise caution in their use, especially in view of the high cost


Orthopaedic Proceedings
Vol. 104-B, Issue SUPP_1 | Pages 18 - 18
1 Jan 2022
Singhal A Jayaraju U Kaur K Clewer G
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Abstract. Background. With the increasingly accepted method of suprapatellar tibial nailing for tibial shaft fractures, we aimed to compare intraoperative and postoperative outcomes of infrapatellar (IP) vs suprapatellar (SP) tibial nails. Methods. A retrospective cohort analysis of 58 patients. 34 SP tibial nails over 3 years versus 24 IP tibial nails over a similar time frame. We compared; radiation exposure, patient positioning time (PPT), non-union rate and follow-up time. Knee pain in the SP group was evaluated, utilising the Hospital for Special Surgery (HSS) Knee injury and Osteoarthritis outcome score (KOOS). Results. 58 patients with a mean age of 43 years were included. Mean intraoperative radiation dose for SP nails was 61.78cGy (range 11.60 to 156.01cGy) vs 121.09cGy (range 58.01 to 18.03cGy) for IP nails (p < 0.05). Mean PPT for SP nails was 10 minutes vs 18 minutes for IP nails (p < 0.05). All fractures united in the SP group vs one non-union in the IP group. Mean follow-up was 5.5 months vs 11 months in the SP and IP group respectively. Mean KOOS was 7 (range 0 to 22) at 6 months for the SP group. Conclusion. The semi extended position (SP group) leads to reduced radiation exposure because of ease of imaging. All Patients in the SP group showed improved outcomes, with shorter follow-up and fracture union. The KOOS revealed SP nail patients had minimal pain and good knee function. This study establishes a management and PROMs baseline for ongoing evaluation of SP nails


Orthopaedic Proceedings
Vol. 103-B, Issue SUPP_6 | Pages 30 - 30
1 May 2021
Shah I Brennan C Nayagam S
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Introduction. To determine the advantages and risks of plating after lengthening (PAL) of tibia in children and adolescents. Materials and Methods. 35 consecutive tibial lengthenings were done for limb length discrepancy (LLD) in 26 patients. Gradual lengthening by an external fixator from a tibial (usually diaphyseal) osteotomy was followed by internal fixation with a lateral tibial submuscular plate. The mean age at the time of the lengthening was 10.3 years (4.8 – 16.8 years). The aetiology for LLD was congenital in 21, acquired in 3, and developmental in 2 patients. The mean follow-up was 4.3 years (8 months – 9.9 years). Results. The mean lengthening was 5cm (3–8.6cm) or 19.1% (10.8 – 35.2%) of the initial length of tibia. It took 78.8 days to reach the target length at a lengthening rate of 0.75mm/day. The mean time to plate substitution after cessation of lengthening was 24.7days/109 days after osteotomy. This led to an average external fixation index (EFI) of 23.1days/cm. Optimisation of this technique by judicious estimation of timing of plate substitution would reduce the EFI. Consolidation was recorded at 192 days after osteotomy. Bone healing index (BHI) was 39.8days/cm and was age dependent: <12 year olds = 37.5 days/cm; 12 years = 44.7 days/cm. Using the estimated consolidation time if treatment was solely by external fixator, calculated by tripling the time taken to reach target length after osteotomy, the BHI in this series would have been 52.9 days/cm (p < 0.001). Knee flexion recovery to > 90 degrees was noted at 153.5 days after plating. One greenstick fracture occurred 116 days after plate insertion, 1 tibial shaft fracture occurred 315 days post removal of plate - both following injury and were treated conservatively. Six episodes of sepsis, 5 superficial and 1 deep were treated with antibiotic suppression. The plates were removed from 28 tibiae, 437.4 days after insertion. Conclusions. Plating after lengthening not only reduces the fixator time but appears to achieve consolidation faster than if treatment was by external fixation alone. This facilitates early recovery of joint motion and limb function


Orthopaedic Proceedings
Vol. 94-B, Issue SUPP_XXXVIII | Pages 135 - 135
1 Sep 2012
Schemitsch EH Investigators S
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Purpose. The SPRINT trial randomized 1226 patients with tibial shaft fractures treated by intramedullary (IM) nailing to reamed versus unreamed groups. Using data from this trial, we completed a subgroup analysis of those patients who required two or more reoperations following the initial IM fracture stabilization. Method. We identified 44 patients with tibial shaft fractures who required two or more reoperations following IM nailing. We considered those that were reamed vs unreamed, open vs closed, those that were planned for reoperation after the 12 month follow up, and the indications for reoperation. Results. Patients that had two or more reoperations were characterized by having more open fractures and fractures of greater severity. Fifteen of 21 (71%) reamed and 10 of 23 unreamed (43%) patients required reoperation to treat infection as their first surgical intervention. Those patients that were initially reamed who developed an infection required a greater number of subsequent surgical procedures compared to those who were not initially reamed (42, 60.8% versus 27, 39.2). Conclusion. Our data suggest that patients whose tibial fractures are reamed and subsequently develop an infection are at risk of requiring more re-operations in the future compared to those whose fractures were not reamed. Further study is required to assess the corroborating consequences of needing multiple re-operations including economic impact, pain and function, as well as strategies to prevent further morbidity in this high risk group of patients


Orthopaedic Proceedings
Vol. 94-B, Issue SUPP_XXXVIII | Pages 178 - 178
1 Sep 2012
Shore BJ Glotzbecker MP Zurakowsky D Matheney TH
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Purpose. Pediatric tibial shaft fractures (TSF) account for 15% of long bone fractures in children. Compartment syndrome (CS) is difficult to diagnose in children, often leading to disastrous outcomes. This study investigated the incidence of CS in TSF and its associated risk factors. Method. A detailed five-year retrospective chart review of TSF treated at a major pediatric hospital. CS was diagnosed clinically or by intra-compartment pressure. Multivariate logistic regression analysis tested age, gender, mechanism of injury, time to surgery, fracture type, and treatment intervention as possible risk factors for CS. Results. There were 216 TSF in 212 children (160 males, 52 females; mean age 13.6 years, range eight-18 years). One hundred and thirty-two (61%) fractures were treated with closed reduction and casting, 36 with external fixation, 21 with flexible intramedullary nails, and 27 with locked intramedullary nails. There were 23 cases of CS (10.6%). Multivariate predictors of CS included age 14 years and older (21/96 = 22%, p < 0.001) and motor vehicle accident (MVA) (12/57 = 21%, p = 0.002). Incidence of CS was 44% among patients 14 and older who sustained MVA (11 of 25). Gender, AO fracture type, time to surgery and surgical fixation were not predictive of CS. Conclusion. This is the first large study to report the incidence of CS from TSF in children. The incidence of 10.6% is higher than previously reported and much higher in patients 14 years of age and older and involved in an MVA. Surgeons should be especially aware and suspicious of CS in children with tibial shaft fractures who have these risk factors


Orthopaedic Proceedings
Vol. 94-B, Issue SUPP_XXIII | Pages 207 - 207
1 May 2012
Adie S Harris I Rae H Dao A Yong S
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Tibial shaft fractures have a high incidence of delayed and non-union, often requiring multiple procedures. Pulsed electromagnetic field (PEMF) stimulation is a safe and effective treatment for tibial non union but little is known about the efficacy of PEMF in preventing non-union in acute fractures. Between August 2005 and December 2008, eligible patients presenting at six major metropolitan hospitals with acute tibial shaft fractures (AO classification 4-2) were included. Participants were randomised by an independent allocation centre to identical active or inactive PEMF devices, both prescribed to be worn ten hours daily for twelve weeks. Baseline data were collected, and patients and surgeons were surveyed serially via post and/or phone at three, six and twelve months. Participants, data collectors and data analysts were blinded. The main outcome was any surgical intervention for delayed/non union. Data from 150 patients (76 active and 74 inactive) were available for analysis (12 month follow up 78%). There was no between-group difference in age, gender, mechanism of injury, open grade, smoking status, or compliance with the device (hours of use). Overall compliance was moderate (5.7 hours daily use). Fifteen of 76 (20%) of active device patients required surgery for delayed/non-union vs. 8 of 74 (11%) in the placebo group; odds ratio of surgery=2.03, p=0.13, 95% CI 0.80 to 5.12. An intention to treat analysis adjusted for open grade and hours the device was used showed an odds ratio of requiring surgery of 1.78 (p=0.24, 95% CI 0.68 to 4.64). A sub-group analysis of 80 compliant patients (defined a priori as a minimum average of six hours daily use) was performed. Nine of 35 (26%) patients with an active device required surgery for delayed/non-union vs. 3 of 45 (7%) in the placebo group; odds ratio of surgery=7.60 (p=0.017, 95% CI 1.43 to 40.24). Based on these unexpected initial results, PEMF stimulation does not prevent revision surgery for delayed/non-union in acute fractures of the tibial shaft


Orthopaedic Proceedings
Vol. 100-B, Issue SUPP_5 | Pages 42 - 42
1 Apr 2018
Londhe S Shah R
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Tibial shaft fractures co-existing with osteoarthritis can increase the challenges for the orthopedic surgeon. The novel Londhe-Shah technique manages both the problems using one-stage total knee arthroplasty with a long stemmed tibial component which has a good diaphyseal fit. Three osteoarthritis patients with fractures of tibial shaft were treated with this technique and were followed up at 6-weeks, 12-weeks and 1-year (figure 1–3). A complete union of the fractured segment was achieved at follow-up without any adverse events such as infection, damage to the implant, and soft-tissue injury during and after surgery. The American Knee Society Score (AKSS) improved and WOMAC pain and stiffness scores reduced at follow-ups suggesting excellent improvement in functionality and patient satisfaction. One-stage TKR with a long-stem extension of the tibial component to bypass the fracture site mends and stabilises the fracture along with the adverse biomechanics at the fracture site while also correcting the arthritis. The single stage procedure allows early ambulation in six weeks. For any figures or tables, please contact the authors directly


Orthopaedic Proceedings
Vol. 95-B, Issue SUPP_19 | Pages 5 - 5
1 Apr 2013
Kazzaz S Kumar P Mahapatra A
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Introduction. We retrospectively evaluated our five years' experience in using Expandable Fixion nail system in tibial diaphyseal fractures. Materials/Methods. Eighteen cases with closed tibial diaphyseal fracture were identified between January 2006 and January 2011, all treated successfully with Fixion intramedullary nail as a primary osteosynthesis device. Results. All patients were followed-up in our department until clinical and radiological fusion was achieved with a mean follow-up of 13 months (range 6–20 months). There was one asymptomatic delayed union at 13 months, treated with regular observation until fusion was achieved. There was no incidence of infection, compartment syndrome or non-union in this group. Conclusion. We conclude from our experience that Expandable Fixion Nail is as effective as traditional locking intramedullary nail system in treating closed tibial shaft fracture with the advantages of shorter theatre time and less radiation exposure


Orthopaedic Proceedings
Vol. 95-B, Issue SUPP_29 | Pages 69 - 69
1 Aug 2013
Howard N Rollinson P
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Methods. We conducted a single centre prospective observational study comparing post-operative infection rates in HIV positive and HIV negative patients presenting with tibial shaft fractures managed with surgical fixation. Results. Twenty eight patients were incorporated over a six month period and followed up for three months post operatively. 25 open fractures including 6 HIV positive patients and 3 closed fractures including 1 HIV positive patient were assessed for signs of wound sepsis assessed with the asepsis wound score. 21 patients treated with external fixation including 4 HIV positive patients were also assessed using Checkett's scoring system for pin site infection. There was no significant difference in post-operative wound infection rates between the HIV positive (mean wound score = 7.7) and HIV negative (mean = 3.7) patients (p=0.162). HIV positive patients were also found to be at no increased risk of pin site sepsis (p=0.520). No correlation was found between CD4 counts of HIV positive patients and wound infection rates. Conclusions. Our results show that HIV positive patients with tibial fractures are not significantly more at risk of wound infection postoperatively. External fixation has also been shown to be a safe effective treatment of open tibial fractures in HIV patients


Orthopaedic Proceedings
Vol. 94-B, Issue SUPP_XXXVIII | Pages 73 - 73
1 Sep 2012
Busse JW Investigators S Group MUSS Bhandari M
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Purpose. We explored the role of patients beliefs and attitudes towards their likelihood of recovery from severe physical trauma. Method. We developed and validated an instrument designed to capture the impact of patients beliefs and attitudes towards functional recovery from injury; the Somatic Pre-Occupation and Coping (SPOC) questionnaire. At six weeks post-surgical fixation, we administered the SPOC questionnaire to 359 consecutive patients with operatively managed tibial shaft fractures. We constructed multi-variable regression models to explore the association between SPOC scores and functional outcome at one year, as measured by return to work and Short Form-36 (SF-36) physical component summary (PCS) and mental component summary (MCS) scores. Results. In our adjusted regression models that included pre-injury SF-36 scores, SPOC scores at six weeks post-surgery accounted for 18% of the variation in SF-36 PCS scores and 18% of SF-36 MCS scores at one year. Our adjusted analysis found that for each 14-point increment in SPOC score (14 points being half the standard deviation of the aggregate score) at six weeks the odds of returning to work at 12 months decreased by 40% (odds ratio = 0.60; 95% CI = 0.50 to 0.73). In all models, six week SPOC scores were a far more powerful predictor of functional recovery than age, gender, fracture type, smoking status, or the presence of multi-trauma. Conclusion. The SPOC questionnaire is a valid measurement of illness beliefs and attitudes in tibial fracture patients and is highly predictive of their long-term functional recovery


Orthopaedic Proceedings
Vol. 95-B, Issue SUPP_1 | Pages 100 - 100
1 Jan 2013
Malhotra K Pai S Radcliffe G
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Aims. Compartment syndrome (CS) is a well-recognised, serious complication of long bone fractures. The association between CS and tibial shaft fractures is well documented in adult patients and in children with open or high velocity trauma. There is, however, little literature on the risk of developing CS in children with closed tibial fractures. In a number of units these children are routinely admitted for elevation and monitoring for CS. We audited our experience of managing paediatric tibial fractures to ascertain whether it may be safe to discharge a sub-group of these children. Methods. We audited all children up to the age of 12 years admitted to our hospital over a 5 year period. We reviewed radiographs and clinical notes to determine fracture pattern, modality of treatment, and complications. Results. We audited 159 tibial fractures. The mean age was 5.8 years (1–12 years), 95 boys, 64 girls. 105 (66%) closed fractures were conservatively managed: 87 of these were diaphyseal and 20 involved both tibia and fibula. Of the conservatively managed fractures, 89 (85%) were minimally displaced (< 5 degrees varus/valgus/anterior angulation, < 5 degrees rotation, < 5mm shortening, no posterior angulation). In the conservatively managed group there were 3 cases of angulation in cast, managed with wedging. There were no other complications and no cases of compartment syndrome. Conclusion. Of the 105 closed tibial fractures we managed conservatively, most were minimally displaced, diaphyseal, tibia-only fractures. No patient developed compartment syndrome. Based on our experience we suggest that children with closed, minimally displaced tibial fractures do not require admission for monitoring of CS and may go home in a plaster-slab with early fracture clinic follow-up providing suitable supervision is in place, pain is controlled, and they are able to mobilise safely


Orthopaedic Proceedings
Vol. 94-B, Issue SUPP_XXI | Pages 104 - 104
1 May 2012
M. B D. DT I. VK V. MP G. B D. S J. S S. V
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Background. Identification of novel therapeutics to accelerate acute fracture healing remains critical. A prostaglandin EP-2 receptor agonist (CP-533,536) has demonstrated acceleration of fracture healing in preclinical models. The objective of this study is to assess the efficacy of a single dose of CP-533,536 in subjects with a closed fracture of the tibial shaft using radiographic measurements compared to placebo treatment. Methods. In a phase II randomised, blinded, placebo-controlled trial, the efficacy of a single local injection of three doses of CP-533,536 (0.5mg, 1.5mg and 15mg) was compared to a placebo and a standard of care arm in patients with closed tibial shaft fractures. The tibial fractures were treated with reamed inter-locked intramedullary nails. Patients were followed at two week intervals to six months with a final evaluation at one year. Fracture healing was independently adjudicated by a radiologist panel and an orthopaedic surgeon panel. Results. Ninety-nine patients were enrolled ranging from 17-76 years in age. Baseline characteristics were comparable across treatment groups. No statistically significant differences in median healing time between any of the CP-533,536 treatment groups and placebo were observed based on the radiology panel assessment; however, significant differences were demonstrated by an orthopaedic panel. At weeks 8, 10, 12, 14 and 16 a higher percentage of subjects in the CP-533,536-1.5 and 0.5 mg groups were considered healed compared to the placebo and the 15 mg groups by the orthopaedic panel assessment. Moreover, the CP-533,536- 0.5 mg group showed a statistically higher (p=0.05) mean radiographic healing score than placebo treated group at weeks 8, 14, 16, 18, and 24. Conclusion. CP-533,536 demonstrated accelerated healing in patients with acute tibia fractures by an orthopaedic panel. Confirmatory trials are required to assure validity of the observed treatment effects


Bone & Joint Research
Vol. 3, Issue 5 | Pages 161 - 168
1 May 2014
Mundi R Chaudhry H Mundi S Godin K Bhandari M

High-quality randomised controlled trials (RCTs) evaluating surgical therapies are fundamental to the delivery of evidence-based orthopaedics. Orthopaedic clinical trials have unique challenges; however, when these challenges are overcome, evidence from trials can be definitive in its impact on surgical practice. In this review, we highlight several issues that pose potential challenges to orthopaedic investigators aiming to perform surgical randomised controlled trials. We begin with a discussion on trial design issues, including the ethics of sham surgery, the importance of sample size, the need for patient-important outcomes, and overcoming expertise bias. We then explore features surrounding the execution of surgical randomised trials, including ethics review boards, the importance of organisational frameworks, and obtaining adequate funding.

Cite this article: Bone Joint Res 2014;3:161–8.