Dataset Information

Reaming Does Not Affect Functional Outcomes After Open and Closed Tibial Shaft Fractures: The Results of a Randomized Controlled Trial.

ABSTRACT:

Objectives

We sought to determine the effect of reaming on 1-year 36-item short-form general health survey (SF-36) and short musculoskeletal function assessment (SMFA) scores from the Study to Prospectively Evaluate Reamed Intramedullary Nails in patients with Tibial Fractures.

Design

Prospective randomized controlled trial.1319 patients were randomized to reamed or unreamed nails. Fractures were categorized as open or closed.

Setting

Twenty-nine academic and community health centers across the US, Canada, and the Netherlands.

Patients/participants

One thousand three hundred and nineteen skeletally mature patients with closed and open diaphyseal tibia fractures.

Intervention

Reamed versus unreamed tibial nails.

Main outcome measurements

SF-36 and the SMFA. Outcomes were obtained during the initial hospitalization to reflect preinjury status, and again at the 2-week, 3-month, 6-month, and 1-year follow-up. Repeated measures analyses were performed with P < 0.05 considered significant.

Results

There were no differences between the reamed and unreamed groups at 12 months for either the SF-36 physical component score [42.9 vs. 43.4, P = 0.54, 95% Confidence Interval for the difference (CI) -2.1 to 1.1] or the SMFA dysfunction index (18.0 vs. 17.6, P = 0.79. 95% CI, -2.2 to 2.9). At one year, functional outcomes were significantly below baseline for the SF-36 physical componentf score, SMFA dysfunction index, and SMFA bothersome index (P < 0.001). Time and fracture type were significantly associated with functional outcome.

Conclusions

Reaming does not affect functional outcomes after intramedullary nailing for tibial shaft fractures. Patients with open fractures have worse functional outcomes than those with a closed injury. Patients do not reach their baseline function by 1 year after surgery.

Level of evidence

Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence.

SUBMITTER: Lin CA

PROVIDER: S-EPMC4761270 | biostudies-literature | 2016 Mar

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Reaming Does Not Affect Functional Outcomes After Open and Closed Tibial Shaft Fractures: The Results of a Randomized Controlled Trial.

Lin Carol A CA Swiontkowski Marc M Bhandari Mohit M Walter Stephen D SD Schemitsch Emil H EH Sanders David D Tornetta Paul P

Journal of orthopaedic trauma 20160301 3

<h4>Objectives</h4>We sought to determine the effect of reaming on 1-year 36-item short-form general health survey (SF-36) and short musculoskeletal function assessment (SMFA) scores from the Study to Prospectively Evaluate Reamed Intramedullary Nails in patients with Tibial Fractures.<h4>Design</h4>Prospective randomized controlled trial.1319 patients were randomized to reamed or unreamed nails. Fractures were categorized as open or closed.<h4>Setting</h4>Twenty-nine academic and community heal ...[more]

PMID: 26618662

Similar Datasets

Project description:BackgroundOpen tibial shaft fractures are one of the most devastating orthopaedic injuries. Surgical treatment options include reamed or unreamed nailing, plating, Ender nails, Ilizarov fixation, and external fixation. Using a network meta-analysis allows comparison and facilitates pooling of a diverse population of randomized trials across these approaches in ways that a traditional meta-analysis does not.Questions/purposesOur aim was to perform a network meta-analysis using evidence from randomized trials on the relative effect of alternative approaches on the risk of unplanned reoperation after open fractures of the tibial diaphysis. Our secondary study endpoints included malunion, deep infection, and superficial infection.MethodsA network meta-analysis allows for simultaneous consideration of the relative effectiveness of multiple treatment alternatives. To do this on the subject of surgical treatments for open tibial fractures, we began with systematic searches of databases (including EMBASE and MEDLINE) and performed hand searches of orthopaedic journals, bibliographies, abstracts from orthopaedic conferences, and orthopaedic textbooks, for all relevant material published between 1980 and 2013. Two authors independently screened abstracts and manuscripts and extracted the data, three evaluated the risk of bias in individual studies, and two applied Grading of Recommendation Assessment, Development and Evaluation (GRADE) criteria to bodies of evidence. We included all randomized and quasirandomized trials comparing two (or more) surgical treatment options for open tibial shaft fractures in predominantly (ie, > 80%) adult patients. We calculated pooled estimates for all direct comparisons and conducted a network meta-analysis combining direct and indirect evidence for all 15 comparisons between six stabilization strategies. Fourteen trials published between 1989 and November 2011 met our inclusion criteria; the trials comprised a total of 1279 patients surgically treated for open tibial shaft fractures.ResultsModerate confidence evidence showed that unreamed nailing may reduce the likelihood of reoperation compared with external fixation (network odds ratio [OR], 0.38; 95% CI, 0.23-0.62; p < 0.05), although not necessarily compared with reamed nailing (direct OR, 0.74; 95% CI, 0.45-1.24; p = 0.25). Only low- or very low-quality evidence informed the primary outcome for other treatment comparisons, such as those involving internal plate fixation, Ilizarov external fixation, and Ender nailing. Method ranking based on reoperation data showed that unreamed nailing had the highest probability of being the best treatment, followed by reamed nailing, external fixation, and plate fixation. CIs around pooled estimates of malunion and infection risk were very wide, and therefore no conclusive results could be made based on these data.ConclusionCurrent evidence suggests that intramedullary nailing may be superior to other fixation strategies for open tibial shaft fractures. Use of unreamed nails over reamed nails also may be advantageous in the setting of open fractures, but this remains to be confirmed. Unfortunately, these conclusions are based on trials that have had high risk of bias and poor precision. Larger and higher-quality head-to-head randomized controlled trials are required to confirm these conclusions and better inform clinical decision-making.Level of evidenceLevel I, therapeutic study.

Project description:ContextAcute tibial shaft fractures represent one of the most severe injuries in sports. Return rates and return-to-sport times after these injuries are limited, particularly with regard to the outcomes of different treatment methods.ObjectiveTo determine the current evidence for the treatment of and return to sport after tibial shaft fractures.Data sourcesOVID/MEDLINE (PubMed), EMBASE, CINAHL, Cochrane Collaboration Database, Web of Science, PEDro, SPORTDiscus, Scopus, and Google Scholar were all searched for articles published from 1988 to 2014.Study selectionInclusion criteria comprised studies of level 1 to 4 evidence, written in the English language, that reported on the management and outcome of tibial shaft fractures and included data on either return-to-sport rate or time. Studies that failed to report on sporting outcomes, those of level 5 evidence, and those in non-English language were excluded.Study designSystematic review.Level of evidenceLevel 4.Data extractionThe search used combinations of the terms tibial, tibia, acute, fracture, athletes, sports, nonoperative, conservative, operative, and return to sport. Two authors independently reviewed the selected articles and created separate data sets, which were subsequently combined for final analysis.ResultsA total of 16 studies (10 retrospective, 3 prospective, 3 randomized controlled trials) were included (n = 889 patients). Seventy-six percent (672/889) of the patients were men, with a mean age of 27.7 years. Surgical management was assessed in 14 studies, and nonsurgical management was assessed in 8 studies. Return to sport ranged from 12 to 54 weeks after surgical intervention and from 28 to 182 weeks after nonsurgical management (mean difference, 69.5 weeks; 95% CI, -83.36 to -55.64; P < 0.01). Fractures treated surgically had a return-to-sport rate of 92%, whereas those treated nonsurgically had a return rate of 67% (risk ratio, 1.37; 95% CI, 1.20 to 1.57; P < 0.01).ConclusionThe general principles are to undertake surgical management for displaced fractures and to attempt nonsurgical management for undisplaced fractures. Primary surgical intervention of undisplaced fractures, however, may result in higher return rates and shorter return times, though this exposes the patient to the risk of surgical complications, which include surgical site infection and compartment syndrome.

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:ImportanceHumeral shaft fractures traditionally have been treated nonsurgically, but there has been a steady increase in the rate of surgery over the past 2 decades without high-quality evidence to justify the trend.ObjectiveTo compare the effectiveness of surgical treatment with open reduction and internal plate fixation to nonsurgical treatment with functional bracing in the treatment of closed humeral shaft fractures.Design, setting, and participantsRandomized clinical trial conducted at 2 university hospital trauma centers in Finland, enrollment between November 2012 and January 2018 with a final follow-up of January 2019. A total of 82 adult patients with closed, unilateral, displaced humeral shaft fracture met criteria for inclusion. Patients were excluded if they had cognitive disabilities preventing them from following the protocol or had multimorbidity or multiple trauma.InterventionsPatients were randomly assigned to surgical treatment with open reduction and internal plate fixation (n = 38) or to nonsurgical treatment with functional bracing (n = 44).Main outcome and measureThe primary outcome was Disabilities of Arm, Shoulder and Hand (DASH) score at 12 months (range, 0 to 100 points, 0 denotes no disability and 100 extreme disability; minimal clinically important difference, 10 points).ResultsAmong 82 patients who were randomized (mean age, 48.9 years; 38 women [46%]; 44 men [54%]), 78 (95%) completed the trial. Thirteen (30%) of the patients assigned to functional bracing underwent surgery during the 12-month follow-up period to promote healing of the fracture. At 12 months, the mean DASH score was 8.9 (95% CI, 4.2 to 13.6) in the surgery group and 12.0 (95% CI, 7.7 to 16.4) in the bracing group (between-group difference, -3.1 points; 95% CI, -9.6 to 3.3; P = .34). Eleven patients (25%) allocated to functional bracing developed fracture nonunion. Three patients (8%) allocated to surgery developed a temporary radial nerve palsy.Conclusions and relevanceAmong patients with closed humeral shaft fracture, internal fixation surgery, compared with nonoperative functional bracing, did not significantly improve functional outcomes at 12 months. However, the substantial amount of treatment crossover from nonoperative to surgical treatment should be considered when interpreting the trial results.Trial registrationClinicalTrials.gov Identifier: NCT01719887.

Project description:PurposeTo examine the condition and triggers of stress fractures of the lateral tibial plateau (LTP) similar to type III lateral hinge fractures (LHFs) after open wedge high tibial osteotomy (OWHTO).MethodsOWHTO was performed in 118 knees. They were examined for LHFs by computed tomography (CT). Patients were divided into the stress fracture group (Group SF) if they showed fracture lines on CT performed after starting weight-bearing walking and the normal group (Group N) for others.ResultsThe mean age was significantly older in Group SF (P = 0.022). Preoperatively, Group SF showed a significantly higher tibio-femoral angle (TFA, P = 0.014). No significant differences were observed in TFA and weight-bearing line ratio after surgery. Correction angle was significantly higher in the SF group. And all of the SF were more than 13 degrees. There was no significant difference in LHF incidence between groups, whereas stress fracture incidence differed significantly for each type of LHF (chi-squared test, P = 0.0001): 14.6% of type I cases, 100% of type II cases, 0% of type III cases, and 6.1% of those without LHF.DiscussionThe load on the LTP is assumed to act as a shearing force in type II fractures, which may contribute greatly to stress fractures. In type III, stress fractures may not occur because of the load dispersed at the fracture part. The stress fracture site is similar to type III LHF, and this kind of fracture is thought to be a delayed type III because it occurs after patients start weight-bearing walking. Moreover, they are observed in type I cases with a stable hinge and in 6% of cases without LHF. This study showed that high varus knees corrected with a large correction angle may develop stress fractures. OWHTO requires attention to stress fractures of the LTP, which can be regarded as delayed type III, in those developing LHFs postoperatively or having a high varus knee preoperatively.ConclusionThese results indicated the possibility of stress fracture in LTP during weight-bearing exercise after OWHTO, which was regarded as a delayed type III fracture. The results showed that Correction angle was more than 13 degrees, and lateral hinge fracture type II of the Takeuchi classification was an inducement of this stress fracture.Level of evidenceLevel IV.

Project description:Existing evidence indicates that surgery fails to provide superior functional outcome over nonoperative care in patients with a closed humeral shaft fracture. However, up to one-third of patients treated nonoperatively may require secondary surgery. To compare the 2-year outcomes of patients who required secondary surgery with the outcomes of patients with successful initial treatment. This 2-year follow-up of the Finnish Shaft of the Humerus (FISH) randomized clinical trial comparing surgery with nonoperative treatment (functional brace) was completed in January 2020. Enrollment in the original trial was between November 2012 and January 2018 at 2 university hospital trauma centers in Finland. A total of 321 adult patients with closed, displaced humeral shaft fracture were assessed for eligibility. After excluding patients with cognitive disabilities, multimorbidity, or multiple trauma and those refusing randomization, 82 patients were randomized. Interventions were surgery with plate fixation (n = 38; initial surgery group) or functional bracing (n = 44); the latter group was divided into the successful fracture healing group (n = 30; bracing group) and the secondary surgery group (n = 14) with fracture healing problems. The primary outcome was Disabilities of Arm, Shoulder and Hand (DASH) score at 2 years (range, 0 to 100 points; 0 denotes no disability, 100 extreme disability; minimal clinically important difference, 10 points). Of 82 randomized patients, 38 (46%) were female. The mean (SD) age was 48.9 (17.1) years. A total of 74 patients (90%) completed the 2-year follow-up. At 2 years, the mean DASH score was 6.8 (95% CI, 2.3 to 11.4) in the initial surgery group, 6.0 (95% CI, 1.0 to 11.0) in the bracing group, and 17.5 (95% CI, 10.5 to 24.5) in the secondary surgery group. The between-group difference was -10.7 points (95% CI, -19.1 to -2.3; P = .01) between the initial and secondary surgery groups and -11.5 points (95% CI, -20.1 to -2.9; P = .009) between the bracing group and secondary surgery group. Patients contemplating treatment for closed humeral shaft fracture should be informed that two-thirds of patients treated with functional bracing may heal successfully while one-third may experience fracture healing problems that require secondary surgery and lead to inferior functional outcomes 2 years after the injury. ClinicalTrials.gov Identifier: NCT01719887.

Dataset Information

Reaming Does Not Affect Functional Outcomes After Open and Closed Tibial Shaft Fractures: The Results of a Randomized Controlled Trial.

Objectives

Design

Setting

Patients/participants

Intervention

Main outcome measurements

Results

Conclusions

Level of evidence

Publications

Reaming Does Not Affect Functional Outcomes After Open and Closed Tibial Shaft Fractures: The Results of a Randomized Controlled Trial.

Similar Datasets

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