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Study to prospectively evaluate reamed intramedually nails in patients with tibial fractures (S.P.R.I.N.T.): study rationale and design.

ABSTRACT: Surgeons agree on the benefits of operative treatment of tibial fractures - the most common of long bone fractures - with an intramedullary rod or nail. Rates of re-operation remain high - between 23% and 60% in prior trials - and the two alternative nailing approaches, reamed or non-reamed, each have a compelling biological rationale and strong proponents, resulting in ongoing controversy regarding which is better.The objective of this trial was to assess the impact of reamed versus non-reamed intramedullary nailing on rates of re-operation in patients with open and closed fractures of the tibial shaft. The study to prospectively evaluate reamed intramedullary nails in tibial fractures (S.P.R.I.N.T) was a multi-center, randomized trial including 29 clinical sites in Canada, the United States and the Netherlands which enrolled 1200 skeletally mature patients with open (Gustilo Types I-IIIB) or closed (Tscherne Types 0-3) fractures of the tibial shaft amenable to surgical treatment with an intramedullary nail. Patients received a statically locked intramedullary nail with either reamed or non-reamed insertion. The first strategy involved fixation of the fracture with an intramedullary nail following reaming to enlarge the intramedullary canal (Reamed Group). The second treatment strategy involved fixation of the fracture with an intramedullary nail without prior reaming of the intramedullary canal (Non-Reamed Group). Patients, outcome assessors, and data analysts were blinded to treatment allocation. Peri-operative care was standardized, and re-operations before 6 months were proscribed. Patients were followed at discharge, 2 weeks post-discharge, and at 6 weeks, 3, 6, 9, and 12 months post surgery. A committee, blinded to allocation, adjudicated all outcomes.The primary outcome was re-operation to promote healing, treat infection, or preserve the limb (fasciotomy for compartment syndrome after nailing). The primary outcome was a composite comprising the following re-operations: bone grafts, implant exchanges, and dynamizations, in patients with fracture gaps less than 1 cm post intramedullary nail insertion. Infections and fasciotomies were considered events irrespective of the fracture gap. We planned a priori to conduct a subgroup analysis of outcomes in patients with open and closed fractures. S.P.R.I.N.T is the largest collaborative trial evaluating alternative orthopaedic surgical interventions in patients with tibial shaft fractures. The methodological rigor will set new benchmarks for future trials in the field and its results will have important impact on patient care. The S.P.R.I.N.T trial was registered [ID NCT00038129] and received research ethics approval (REB#99-077).

SUBMITTER: SPRINT Investigators

PROVIDER: S-EPMC2446397 | biostudies-literature | 2008 Jun

REPOSITORIES: biostudies-literature

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Study to prospectively evaluate reamed intramedually nails in patients with tibial fractures (S.P.R.I.N.T.): study rationale and design.

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

BMC musculoskeletal disorders 20080623

<h4>Background</h4>Surgeons agree on the benefits of operative treatment of tibial fractures - the most common of long bone fractures - with an intramedullary rod or nail. Rates of re-operation remain high - between 23% and 60% in prior trials - and the two alternative nailing approaches, reamed or non-reamed, each have a compelling biological rationale and strong proponents, resulting in ongoing controversy regarding which is better.<h4>Methods/design</h4>The objective of this trial was to asse ...[more]

PMID: 18573205

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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:The role of low-intensity pulsed ultrasound (LIPUS) in the management of fractures remains controversial. The purpose of this study was to assess the feasibility of a definitive trial to determine the effect of LIPUS on functional and clinical outcomes in tibial fractures managed operatively.We conducted a multicenter, concealed, blinded randomized trial of 51 skeletally mature adults with operatively managed tibial fractures who were treated with either LIPUS or a sham device. All participating centers were located in Canada and site investigators were orthopedic surgeons specializing in trauma surgery. The goals of our pilot study were to determine recruitment rates in individual centers, investigators' ability to adhere to study protocol and data collection procedures, our ability to achieve close to 100% follow-up rates, and the degree to which patients were compliant with treatment. Patients were followed for one year and a committee (blinded to allocation) adjudicated all outcomes. The committee adjudicators were experienced (10 or more years in practice) orthopedic surgeons with formal research training, specializing in trauma surgery.Our overall rate of recruitment was approximately 0.8 patients per center per month and site investigators successfully adhered to the study protocol and procedures. Our rate of follow-up at one year was 84%. Patient compliance, measured by an internal timer in the study devices, revealed that 39 (76%) of the patients were fully compliant and 12 (24%) demonstrated a greater than 50% compliance. Based on patient feedback regarding excessive questionnaire burden, we conducted an analysis using data from another tibial fracture trial that revealed the Short Musculoskeletal Function Assessment (SMFA) dysfunction index offered no important advantages over the SF-36 Physical Component Summary (PCS) score. No device-related adverse events were reported.Our pilot study identified key issues that might have rendered a definitive trial unfeasible. By modifying our protocol to address these challenges we have enhanced the feasibility of a definitive trial to explore the effect of LIPUS on tibial fracture healing.The TRUST definitive trial was registered at ClinicalTrials.gov on 21 April 2008 (identifier: NCT00667849).

Project description:ObjectivesThis study was performed to determine (1) the incidence of humeral shaft fractures within the Medicare noncancer population, (2) the trends in utilization of humeral shaft fixation techniques by plate-and-screw devices and intramedullary nails, (3) differences in procedure times, and (4) the outcomes of individuals as measured by rate of secondary operations and 1-year mortality.Design/settingRetrospective comparative cohort analysis. A cancer-free Medicare part B claims sample derived from a 5% sample from the years 1993 to 2007 was analyzed.Patients/interventionOur cohorts were generated by diagnostic and procedural codes for humeral shaft fractures.Main outcome measurementThe incidence of humeral shaft fracture and trend in operative fixation were evaluated for all years of data. Surgical times were assessed by anesthesia Current Procedural Terminology codes. Outcomes and complications were assessed by Current Procedural Terminology codes. The proportion of individuals experiencing complications and 1-year mortality were compared by proportion hazards.ResultsWe identified 1385 claims for humeral shaft fractures over 15 years, with an adjusted rate of between 12.0 and 23.4 fractures per 100,000 beneficiaries. We identified 511 individuals who received surgical treatment for humeral shaft fractures, 451 of whom had complete 1-year follow-up data. Nail fixation was more prevalent than plate fixation most years and had shorter anesthesia time by 27.1 minutes (P < 0.0001). There were no significant differences in the complication rates between the 2 groups as measured by incidence of secondary operations and 1-year mortality.ConclusionsIntramedullary nails are used for the majority of operative humeral shaft fractures among Medicare beneficiaries. Nailing has a shorter mean operative time. The 2 surgical techniques had no significant differences in terms of risk of secondary procedures and 1-year mortality.Level of evidence: Prognostic Level II. See Instructions for Authors for a complete description of levels of evidence.

Project description:BackgroundTibial shaft fractures (TSFs) are among the most common long bone injuries often resulting from high-energy trauma. To date, musculoskeletal complications such as fracture-related infection (FRI) and compromised fracture healing following fracture fixation of these injuries are still prevalent. The relatively high complication rates prove that, despite advances in modern fracture care, the management of TSFs remains a challenge even in the hands of experienced surgeons. Therefore, the Fracture-Related Outcome Study for operatively treated Tibia shaft fractures (F.R.O.S.T.) aims at creating a registry that enables data mining to gather detailed information to support future clinical decision-making regarding the management of TSF's.MethodsThis prospective, international, multicenter, observational registry for TSFs was recently developed. Recruitment started in 2019 and is planned to take 36 months, seeking to enroll a minimum of 1000 patients. The study protocol does not influence the clinical decision-making procedure, implant choice, or surgical/imaging techniques; these are being performed as per local hospital standard of care. Data collected in this registry include injury specifics, treatment details, clinical outcomes (e.g., FRI), patient-reported outcomes, and procedure- or implant-related adverse events. The minimum follow up is 12 months.DiscussionAlthough over the past decades, multiple high-quality studies have addressed individual research questions related to the outcome of TSFs, knowledge gaps remain. The scarcity of data calls for an international high-quality, population-based registry. Creating such a database could optimize strategies intended to prevent severe musculoskeletal complications. The main purpose of the F.R.O.S.T registry is to evaluate the association between different treatment strategies and patient outcomes. It will address not only operative techniques and implant materials but also perioperative preventive measures. For the first time, data concerning systemic perioperative antibiotic prophylaxis, the influence of local antimicrobials, and timing of soft-tissue coverage will be collected at an international level and correlated with standardized outcome measures in a large prospective, multicenter, observational registry for global accessibility.Trial registrationClinicalTrials.gov : NCT03598530 .

Dataset Information

Study to prospectively evaluate reamed intramedually nails in patients with tibial fractures (S.P.R.I.N.T.): study rationale and design.

Publications

Study to prospectively evaluate reamed intramedually nails in patients with tibial fractures (S.P.R.I.N.T.): study rationale and design.

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