Trial reportBMC musculoskeletal disorders2021
Is early full weight bearing safe following locking plate ORIF of distal fibula fractures?
Trial report in BMC musculoskeletal disorders, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04370561 (a Prospective Randomized Study on the Outcome Following Osteosynthesis of Distal Fibula Fracture Using Semitubular Plate in AO Technique vs. Polyaxial Locking Plates), which is not on this map. Cited by 10 papers, 2 of them syntheses that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
a Prospective Randomized Study on the Outcome Following Osteosynthesis of Distal Fibula Fracture Using Semitubular Plate in AO Technique vs. Polyaxial Locking Plates
Who cites it
10 citing papers in PubMed, 2 syntheses or guidelines pooled it, 23 citations in OpenAlex.
- Early weight-bearing after ankle fracture surgery: a systematic review and meta-analysis of functional outcomes and safety.Journal of orthopaedic surgery and research · 2025Pooled it
- A comparison of outcomes of locking versus non-locking plate fixation for the distal fibula fractures: a systematic review and meta-analysis.European journal of orthopaedic surgery & traumatology : orthopedie traumatologie · 2024Pooled it
- Plain X-ray is insufficient for correct diagnosis of tibial shaft spiral fractures: a prospective trial.European journal of trauma and emergency surgery : official publication of the European Trauma Society · 2023Trial
- Distal Third Minimally Displaced Stress Fracture of Fibula in a Military Recruit: A Case Report and Review of Literature.Case reports in orthopedics · 2026Article
- Lateral Plate Versus Isolated Lag Screw Fixation of Unstable Distal Fibula Fractures: A Systematic Review.Advances in orthopedics · 2026Article
- Isolated distal fibula fractures can be treated with locking screw plates with an immediate postoperative weight-bearing.Musculoskeletal surgery · 2025Article
- The Fracture Ankle Implant Review (FAIR) study : a national multicentre retrospective review of practice in implant choice, fixation methods, and outcomes in fixation of the fibula in ankle fractures.Bone & joint open · 2025Article
- Finite element analysis and a pilot study of different fixation constructs for Danis-Weber A and B lateral malleolus fractures.BMC musculoskeletal disorders · 2023Article
- The Effectiveness of Three-Dimensional Osteosynthesis Plates versus Conventional Plates for the Treatment of Skeletal Fractures: A Systematic Review and Meta-Analysis.Journal of clinical medicine · 2023Review
- A Prospective Randomized Study Comparing Functional Outcome in Distal Fibula Fractures between Conventional AO Semitubular Plating and Minimal Invasive Intramedullary "Photodynamic Bone Stabilisation".Journal of clinical medicine · 2022Article
Corrections and comments
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Authors and funding
9 authors at 1 institution in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundIn the modern western world appraisal of economical points such as treatment and disability after trauma present a financial burden. In this context open reduction internal fixation techniques allowing for early full weight bearing might not only improve the clinical outcome but also shorten the period of disability in working life. The aim of the study was to analyze whether ORIF of ankle fractures using either a standard semitubular plate or a new polyaxial locking plate system result in a better clinical outcome.
methodsIn this prospective study, all patients with distal fibula fractures (AO 44 B1.1, B1.2, B1.3), with indication for surgery were included. Patients were randomized to either the DePuy Synthes® one-third semitubular plate (Group I) or NEWCLIP TECHNICS, Active Ankle® polyaxial locking plate (Group II). Primary outcome parameter was function of the ankle joint, assessed by the Olerud and Molander ankle score, Foot and Ankle outcome score and Karlsson and Peterson Scoring System for Ankle function. Secondary outcome parameter were postoperative complications. Superficial wound infection, delayed wound healing, mechanically prominent implant, skin irritations were considered as minor and deep wound infection, material loosening, loss of reduction were regarded as major complications requiring revision surgery. Clinical and radiological follow-up were performed 6 and 12 weeks, 6 months and 1 year postoperatively.
resultsFifty-two patients (31 W/21 M) with a mean age of 43 yrs. (range 22-64 yrs.) were enrolled. Seven patients (13.5%) were excluded, so that 45 patients were available for follow up. Twenty-five patients were treated with DePuy Synthes® one-third semitubular plate (55.6%; group I) while 20 patients received an anatomically preformed polyaxial locking plate (44.4%, group II). Four minor complications occurred in Group I (16%) compared to two minor complications in group II (10%). Significant better clinical results regarding OMAS (p < 0.02, < 0.04), KPSS (p < 0.04) and FAOS (p < 0.02, < 0.03) were observed 6 and 12 weeks after surgery in group II.
conclusionsThe results of the presented study demonstrate a significant better clinical functional outcome in the early postoperative follow-up in patients treated with a polyaxial locking plate. Furthermore, our data show that ORIF using polyaxial locking plates in combination with an early postoperative weight bearing presents a safe, stable treatment option for ankle fractures so that patients benefit especially in the early stages of recovery.
trial registrationRegistered 20 April 2020, retrospectively on ClinicalTrails.gov ( NCT04370561 ).
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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.