Dataset Information

Casting versus flexible intramedullary nailing in displaced forearm shaft fractures in children aged 7-12 years: a study protocol for a randomised controlled trial.

ABSTRACT:

Introduction

The forearm is the most common fracture location in children, with an increasing incidence. Displaced forearm shaft fractures have traditionally been treated with closed reduction and cast immobilisation. Diaphyseal fractures in children have poor remodelling capacity. Malunion can cause permanent cosmetic and functional disability. Internal fixation with flexible intramedullary nails has gained increasing popularity, without evidence of a better outcome compared with closed reduction and cast immobilisation.

Method and analysis

This is a multicentre, randomised superiority trial comparing closed reduction and cast immobilisation to flexible intramedullary nails in children aged 7-12 years with >10° of angulation and/or >10 mm of shortening in displaced both bone forearm shaft fractures (AO-paediatric classification: 22D/2.1-5.2). A total of 78 patients with minimum 2 years of expected growth left are randomised in 1:1 ratio to either treatment group. The study has a parallel non-randomised patient preference arm. Both treatments are performed under general anaesthesia. In the cast group a long arm cast is applied for 6 weeks. The flexible intramedullary nail group is immobilised in a collar and cuff sling for 4 weeks. Data are collected at baseline and at each follow-up until 1 year.Primary outcome is (1) PROMIS paediatric upper extremity and (2) forearm pronation-supination range of motion at 1-year follow-up. Secondary outcomes are Quick DASH, Paediatric Pain Questionnaire, Cosmetic Visual Analogue Scale, wrist and elbow range of motion as well as any complications and costs of treatment.We hypothesise that flexible intramedullary nailing results in a superior outcome.

Ethics and dissemination

We have received ethical board approval (number: 78/1801/2020) and permissions to conduct the study from all five participating university hospitals. Informed consent is obtained from the parent(s). Results will be disseminated in peer-reviewed publications.

Trial registration number

NCT04664517.

SUBMITTER: Grahn P

PROVIDER: S-EPMC8381323 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:BackgroundThere remains a compelling biological rationale for both reamed and unreamed intramedullary nailing for the treatment of tibial shaft fractures. Previous small trials have left the evidence for either approach inconclusive. We compared reamed and unreamed intramedullary nailing with regard to the rates of reoperations and complications in patients with tibial shaft fractures.MethodsWe conducted a multicenter, blinded randomized trial of 1319 adults in whom a tibial shaft fracture was treated with either reamed or unreamed intramedullary nailing. Perioperative care was standardized, and reoperations for nonunion before six months were disallowed. The primary composite outcome measured at twelve months postoperatively included bone-grafting, implant exchange, and dynamization in patients with a fracture gap of <1 cm. Infection and fasciotomy were considered as part of the composite outcome, irrespective of the postoperative gap.ResultsOne thousand two hundred and twenty-six participants (93%) completed one year of follow-up. Of these, 622 patients were randomized to reamed nailing and 604 patients were randomized to unreamed nailing. Among all patients, fifty-seven (4.6%) required implant exchange or bone-grafting because of nonunion. Among all patients, 105 in the reamed nailing group and 114 in the unreamed nailing group experienced a primary outcome event (relative risk, 0.90; 95% confidence interval, 0.71 to 1.15). In patients with closed fractures, forty-five (11%) of 416 in the reamed nailing group and sixty-eight (17%) of 410 in the unreamed nailing group experienced a primary event (relative risk, 0.67; 95% confidence interval, 0.47 to 0.96; p = 0.03). This difference was largely due to differences in dynamization. In patients with open fractures, sixty of 206 in the reamed nailing group and forty-six of 194 in the unreamed nailing group experienced a primary event (relative risk, 1.27; 95% confidence interval, 0.91 to 1.78; p = 0.16).ConclusionsThe present study demonstrates a possible benefit for reamed intramedullary nailing in patients with closed fractures. We found no difference between approaches in patients with open fractures. Delaying reoperation for nonunion for at least six months may substantially decrease the need for reoperation.

Project description:(1) Background: Diaphyseal forearm fractures are a common injury in children and adolescents. When operative treatment is needed, elastic stable intramedullary nailing (ESIN) is the most common surgical procedure. Although there is no clear evidence, hardware removal after fracture healing is performed in many patients. Often, the primary minimal invasive incision needs to be widened during implant removal. In order to decrease the burden of care of pediatric fractures, significant efforts were made to develop biodegradable implants, which make hardware removal unnecessary. Our study will conduct an observational trial on the clinical use of the Activa IM-Nail™ in forearm fractures in children between 3 and 13 years of age. The objective of this trial is to evaluate the risks and benefits of the Activa IM-Nail™. Among other objectives, the rate of refracture will be determined. (2) Methods: An international Europe-based, multicenter, prospective, single-arm, open-label study will be performed to ascertain the rate of refracture and to determine the subjective benefits of Activa IM-Nail™ for patients, parents and other caregivers. The study will include clinical follow-up including early post-operative complication, radiographs until bony healing and an additional follow-up after 1 year. At this stage, preliminary results and early complications on 76 patients are analyzed in this study and presented. (3) Results: As of April 2022, 76 patients were enrolled as per study protocol. There were 31 girls (40.8%) and 45 boys (59.2%). The mean age at the time of inclusion was 8.9 years (±2.4 years). The mean operation time was 58.9 ± 22.9 min (range, 15-119 min). The mean follow-up time was 8.9 ± 5.1 months (range, 0.2-18.6). Up to now, one refracture has occurred in one child falling from a height of about one meter 7 months after index surgery (1/76; 1.3%). (4) Conclusion: The research project assesses the safety and effectiveness of Activa IM-Nails™ as part of the surgical treatment of dislocated forearm fractures in children in the context of a PMCF study. The use of Activa IM-Nails™ with regard to various objectives, including postoperative complications and refracture rate, seems to be equal to the standard titan ESIN procedure compared to the literature. Preliminary results are encouraging and are made available.

Project description:BackgroundTibiotalocalcaneal (TTC) intramedullary nailing has been suggested as an alternative to open reduction and internal fixation (ORIF) for the primary treatment of unstable fragility ankle fractures with a poor soft tissue envelope. This study aims to investigate the clinical efficacy of TTC intramedullary nail fixation for the primary treatment of unstable ankle fractures in frail elderly patients with poor soft tissue condition, by assessing the number of postoperative complications and the patient-reported functional outcomes.MethodsA retrospective cohort study was performed including patients with an unstable ankle fracture treated between 2015 and 2019 with TTC stabilization using a retrograde intramedullary hindfoot nail that was inserted without joint preparation and allowing immediate weight-bearing postoperatively. The primary outcome was the total number of postoperative complications.ResultsA total of 10 patients were included out of 365 operatively treated ankle fractures. The mean age was 85.2 years (range 66-92) with a mean follow-up of 11.2 months (range 6-16). Fracture types included AO/OTA 44-B2 (n = 1), 44-B3 (n = 6), 44-C1 (n = 2) and 44-C3 (n = 1). Postoperative complications were observed in 4 patients (40%), including 3 nonunions, 2 implant related complications and 1 wound infection. No wound healing disorder or below-the-knee amputation was observed. Four patients (40%) deceased between post-operative 6 to 16 months due to medical conditions unrelated to surgery. The mean Foot and Ankle Outcome Score was 52.6 (range 44.2-73.8).ConclusionHindfoot nailingis a viable treatment option in selected high-risk patients with an advanced age, unstable ankle fractures with significant bone loss, poor soft tissue condition and/or severely impaired pre-injury mobility. In a frail geriatric population, hindfoot nailing may be a safe alternative fixation method with a low risk of wound complication or major amputation. However, unprepared joint may lead to symptomatic nonunion after TTC intramedullary nailing.

Project description:Elastic stable intramedullary nailing (ESIN) has been established as state of the art treatment for forearm fractures in children, if operative stabilization is required. Their use has been expanded to single bone shaft fractures, and also more complex injuries such as Monteggia fractures or Monteggia-like lesions. A wide range of complications has been reported in the literature, up to 70% in certain investigations. The purpose of this study was to assess the complication rate after ESIN treatment of forearm fractures in children and adolescents in a representative cohort of patients from a level 1 trauma center in Germany.Between 2000 and 2015, we retrospectively analyzed all patients, up to the age of 16 years, with forearm fractures, who were operatively treated using ESIN in our department of general and trauma surgery. The main outcome measurements were the rates of postoperative complications after ESIN such as re-fracture, malunion, nonunion, tendon lesion, wound infection, and limited range of motion.In all, 201 consecutive patients with 202 forearm fractures were included in this study. Age averaged 9.7 years (range 3-16 years). Fifteen (7.4%) fractures were open. Fractures were 82.2% diaphyseal both-bone forearm fractures. Follow-up averaged 10.2 months (range 0.7-176.3 months). Complications were 10 re-fractures, 2 malunions, 3 extensor pollicis longus tendon ruptures, 1 superficial wound infection, and 2 limited range of motions. Fourteen (6.9%) children required a secondary operative intervention for their complication. Time to implant removal averaged 3.8 months (range 0.4-16.3 months).Elastic stable intramedullary nailing is a minimally invasive and reliable technique with a low complication rate. Both-bone forearm fractures and single bone fractures, and also Monteggia and Monteggia-equivalent fractures can be successfully treated with this method. As a major complication, re-fractures are frequently seen, even with ESIN in situ.

Project description:BackgroundTibial shaft fractures are the most common long-bone injury, with a reported annual incidence of more than 75 000 in the United States. This study aimed to determine whether patients with tibial fractures managed with intramedullary nails experience a lower rate of reoperation if treated at higher-volume hospitals, or by higher-volume or more experienced surgeons.MethodsThe Study to Prospectively Evaluate Reamed Intramedullary Nails in Patients with Tibial Fractures (SPRINT) was a multicentre randomized clinical trial comparing reamed and nonreamed intramedullary nailing on rates of reoperation to promote fracture union, treat infection or preserve the limb in patients with open and closed fractures of the tibial shaft. Using data from SPRINT, we quantified centre and surgeon volumes into quintiles. We performed analyses adjusted for type of fracture (open v. closed), type of injury (isolated v. multitrauma), gender and age for the primary outcome of reoperation using multivariable logistic regression.ResultsThere were no significant differences in the odds of reoperation between high- and low-volume centres (p = 0.9). Overall, surgeon volume significantly affected the odds of reoperation (p = 0.03). The odds of reoperation among patients treated by moderate-volume surgeons were 50% less than those among patients treated by verylow-volume surgeons (odds ratio [OR] 0.50, 95% confidence interval [CI] 0.28–0.88), and the odds of reoperation among patients treated by high-volume surgeons were 47% less than those among patients treated by very-low-volume surgeons (OR 0.53, 95% CI 0.30–0.93).ConclusionThere appears to be no significant additional patient benefit in treatment by a higher-volume centre for intramedullary fixation of tibial shaft fractures. Additional research on the effects of surgical and clinical site volume in tibial shaft fracture management is needed to confirm this finding. The odds of reoperation were higher in patients treated by very-low-volume surgeons; this finding may be used to optimize the results of tibial shaft fracture management. Clinical trial registration: ClinicalTrials.gov, NCT00038129