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Clinical outcomes in the surgical management of ankle fractures: A systematic review and meta-analysis of fibular intramedullary nail fixation vs. open reduction and internal fixation in randomized controlled trials
Affiliation:1. Department of Orthopaedic Surgery, Valley Hospital Medical Center, Las Vegas, NV, USA;2. The Foot and Ankle Institute at Desert Orthopaedic Center, Las Vegas, NV, USA;3. Kirk Kerkorian School of Medicine at UNLV, Las Vegas, NV, USA;1. Department of Orthopedic Surgery, Osaka Medical and Pharmaceutical University, 2-7, Daigaku-machi, Takatsuki 569-8686, Japan;2. Department of Orthopedic Surgery, Nishinomiya Kyoritsu Neurosurgical Hospital, 11-1, Imazuyamanaka-Cho, Nishinomiya 663-8211, Japan;3. Faculty of Nursing, Osaka Medical and Pharmaceutical University, 7-6, Hatchonishi-machi, Takatsuki 569-0095, Japan;1. Ramsay Santé Clinique de l′Union, Centre de Chirurgie de la Cheville et du Pied, Saint Jean, France;2. Department of Public Health, Orthopaedic and Traumatology Unit, University Federico II of Naples, Naples, Italy;3. Department of Orthopedics and Rehabilitation, University of Iowa, Carver College of Medicine, Iowa City, IA, USA;4. Department of Orthopedics and Traumatology, CHU of Rouen, Rouen, France;5. Department of Orthopaedics, Trauma and Reconstructive Surgery, University Medical Center Hamburg-Eppendorf, Hamburg, Germany;6. Department of Orthopaedics, University of Utah, Salt Lake City, UT, USA;1. Department of Orthopedic Surgery, Clinique Rive Gauche, 49 allée Charles de Fitte, 31300 Toulouse, France;2. Department of Orthopedic Surgery, Jose R. Reyes Memorial Medical Center San Lazaro Compound, Rizal Avenue Sta. Cruz, Manila, Metro Manila 1012, Philippines;1. Trauma Department, AUVA Unfallkrankenhaus, Salzburg, Dr. Franz-Rehrl-Platz 5, A-5010 Salzburg, Austria;2. Ludwig-Boltzmann-Institute for Experimental and Clinical Traumatology in AUVA Trauma Research Center, Donaueschingenstrasse 13, A-1200 Wien, Austria;3. Fußzentrum Wels, Vogelweiderstraße 3b, A-4600 Wels, Austria;4. Privat Hospital Maria Hilf, Radetzkystrasse 35, A-9020 Klagenfurt, Austria
Abstract:BackgroundWhat level I evidence exists to support the use of FNF for surgical management of ankle fractures in high risk patients? The purpose of this study was to compare clinical outcomes following fibular intramedullary nail fixation (FNF) and open reduction and internal fixation (ORIF) of ankle fractures.MethodsA systematic review of the current literature was performed according to Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA) guidelines. Certainty of evidence reported according to GRADE (Grading of Recommendations Assessment, Development, and Evaluation). Our primary hypothesis was that patients undergoing FNF procedures to manage an ankle fracture would have significantly higher patient reported outcome scores (PROs) than patients undergoing ORIF. Primary study outcome measures were validated PROs. Secondary outcome measures included complication rate, secondary surgery rate, and bony union.ResultsThe primary outcome analysis revealed no evidence of a significant effect difference on Olerud and Molander Ankle Score (OMAS) PRO and no evidence of statistical heterogeneity. Secondary outcome analysis revealed a significant 0.30 (0.12–0.74 95CI) relative risk reduction for complications in FNF (P = 0.008). No evidence of an effect difference for bony union. The GRADE certainty of the evidence was rated as low for bone union. No evidence of reporting bias was appreciated. Sensitivity analyses did not significantly alter effect estimates.ConclusionThis systematic review and meta-analysis restricted to evidence derived from RCTs revealed that the quality of evidence is reasonably strong and likely sufficient to conclude: (1) there is likely no clinically important difference between FNF and ORIF up to 12 months post-operatively, as defined by OMS (moderate certainty); (2) surgeons may reasonably expect reduced complications in 14 out of every 100 patients treated with FNF (moderate certainty); (3) there is likely no difference in bony union (low certainty). Future studies should investigate more patient-centered outcomes and if short-term findings are durable over time if these findings apply to lower risk populations.Level of EvidenceSystematic review and meta-analysis of level I evidence
Keywords:Fibula  Intramedullary nail (IMN)  Ankle joint  Fibular nail  Ankle fracture
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