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Randomized trial of reamed and unreamed intramedullary nailing of tibial shaft fractures.

ABSTRACT: There 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.We 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.One 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).The 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.

SUBMITTER: Study to Prospectively Evaluate Reamed Intramedullary Nails in Patients with Tibial Fractures Investigators

PROVIDER: S-EPMC2663330 | biostudies-literature | 2008 Dec

REPOSITORIES: biostudies-literature

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Randomized trial of reamed and unreamed intramedullary nailing of tibial shaft fractures.

Bhandari Mohit M Guyatt Gordon G Tornetta Paul P Schemitsch Emil H EH Swiontkowski Marc M Sanders David D Walter Stephen D SD

The Journal of bone and joint surgery. American volume 20081201 12

<h4>Background</h4>There 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.<h4>Methods</h4>We conducted a multicenter, blinded randomized trial of 1319 adults in whom a tibial sh ...[more]

PMID: 19047701

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Project description:IntroductionActive learning methods have accumulated popularity due to improved results in knowledge acquisition as opposed to passive learning methods. For surgical resident physicians with limited training opportunities outside of the operating room due to time constraints, virtual reality (VR) is a relatively inexpensive and time-efficient active training method for procurement of surgical skills. We conducted a simulated intramedullary nailing (IMN) of a tibia to demonstrate VR training programs as a more effective modality of learning orthopedic surgical techniques compared to passive learning tools such as a standard guide (SG) through trained novice medical students performing a SawBones simulation of intramedullary nail fixation.Materials and methodsFirst and second-year medical students without prior experience of procedure were recruited and randomized to SG or VR training. Participants were observed performing simulated tibia IMN procedure immediately after training and evaluated by a blinded attending surgeon using procedure-specific checklist and 5-point global assessment scale. Participants returned after 2-weeks for repeat training and evaluation.Results20 participants were recruited and randomized into VR (n = 10) and SG (n = 10) groups. All 20 participants completed the first phase and 17 completed the second phase of the study. Aggregate global assessment scores were significantly higher for VR than SG group (17.5 vs. 7.5, p < 0.001), including scores in all individual categories. The percentage of steps completed correctly was significantly higher in the VR group compared to the SG group (63% vs. 25%, p < 0.002). Average improvement between the first and second phases of the study were higher in the VR group compared to SG group across all 5-categories of the global assessment scale, and significantly higher for knowledge of instruments (50% vs. 11%, p, 0.01).DiscussionVR training was more effective than a passive SG in our model of simulated tibia IMN for novice medical students. Virtual reality training may be a useful method to augment orthopedic education.

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

Project description:BackgroundOpen tibial fractures are common injuries in low and middle-income countries, but there is no consensus regarding treatment with intramedullary nailing versus external fixation. The purpose of the present study was to compare the outcomes of initial treatment with intramedullary nailing or external fixation in adults with open tibial fractures.MethodsWe conducted a randomized clinical trial (RCT) at a tertiary orthopaedic center in Tanzania. Adults with acute diaphyseal open tibial fractures were randomly assigned to statically locked, hand-reamed intramedullary nailing or uniplanar external fixation. The primary outcome was death or reoperation for the treatment of deep infection, nonunion, or malalignment. Secondary outcomes included quality of life as measured with the EuroQol-5 Dimensions (EQ-5D) questionnaire, radiographic alignment, and healing as measured with the modified Radiographic Union Scale for Tibial fractures (mRUST).ResultsOf the 240 patients who were enrolled, 221 (92.1%) (including 111 managed with intramedullary nailing and 110 managed with external fixation) completed 1-year follow-up. There were 44 primary outcome events (with rates of 18.0% and 21.9% in the intramedullary nailing and external fixation groups, respectively) (relative risk [RR] = 0.83 [95% confidence interval (CI), 0.49 to 1.41]; p = 0.505). There was no significant difference between the groups in terms of the rate of deep infection. Intramedullary nailing was associated with a lower risk of coronal malalignment (RR = 0.11 [95% CI, 0.01 to 0.85]; p = 0.01) and sagittal malalignment (RR = 0.17 [95% CI, 0.02 to 1.35]; p = 0.065) at 1 year. The EQ-5D index favored intramedullary nailing at 6 weeks (mean difference [MD] = 0.07 [95% CI = 0.03 to 0.11]; p < 0.001), but this difference dissipated by 1 year. Radiographic healing (mRUST) favored intramedullary nailing at 6 weeks (MD = 1.2 [95% CI = 0.4 to 2.0]; p = 0.005), 12 weeks (MD = 1.0 [95% CI = 0.3 to 1.7]; p = 0.005), and 1 year (MD = 0.8 [95% CI = 0.2 to 1.5]; p = 0.013).ConclusionsTo our knowledge, the present study is the first RCT assessing intramedullary nailing versus external fixation for the treatment of open tibial fractures in sub-Saharan Africa. Differences in primary events were not detected, and only coronal alignment significantly favored the use of intramedullary nailing.Level of evidenceTherapeutic Level I. See Instructions for Authors for a complete description of levels of evidence.

Project description:ObjectivesDetermine the impact of infections on direct costs and healthcare resource use in England for patients undergoing intramedullary nailing (IMN) for tibial shaft fractures.DesignNon-concurrent cohort based on retrospectively collected data with 2-year follow-up.SettingEngland.ParticipantsThe study population included adult patients (≥18 years) in England with a diagnosis of tibial shaft fracture (International Classification of Diseases-10, S822) in the inpatient setting between May 2003 and June 2017 followed by a procedure for IMN for tibial shaft fracture within 30 days. Patient data were derived from the Clinical Practice Research Datalink linked to National Health Service Hospital Episode Statistics datasets.Primary independent variableInfection.Primary and secondary outcome measuresThe primary outcome was total inpatient costs from index stay admission through 1 year of follow-up. Secondary outcome included cumulative total healthcare costs, and resource utilisation at 30 days, 90 days, 1 year and 2 years.ResultsOverall, 805 patients met the inclusion criteria. At index inpatient stay, 3.7% had a post-IMN infection, rising to 11.7% at 1 year. One-year inpatient costs were 80% higher for patients with infection (p<0.001). Total costs were estimated to be £14 756 (95% CI £13 123 to £16 593) for patients with infection versus £8279 (95% CI £7946 to £8626). Length of stay (LOS), readmission and reoperation were the key drivers of healthcare costs (all p<0.001). After adjustment, LOS was higher by 109% (95% CI 62% to 169%), from 10.5 days to 21.9 days, for patients with infection. The odds of being readmitted or requiring reoperation were higher by 5.18 times (95% CI 3.01 to 9.13) and 2.47 times (95% CI 1.48 to 4.09), respectively, for patients with infection versus those without infection.ConclusionsPost-IMN infection significantly increases inpatient costs, LOS, readmissions and reoperations associated with tibial fracture fixation. Healthcare burden could be reduced through novel surgical site infection prevention strategies.

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:IntroductionThe 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 analysisThis 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 disseminationWe 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 numberNCT04664517.

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Randomized trial of reamed and unreamed intramedullary nailing of tibial shaft fractures.

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Randomized trial of reamed and unreamed intramedullary nailing of tibial shaft fractures.

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