Trial reportThe bone & joint journal2021
Functional outcome of routine versus on-demand removal of the syndesmotic screw: a multicentre randomized controlled trial.
Trial report in The bone & joint journal, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 19 papers.
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.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
19 citing papers in PubMed.
- The Minimal Clinically Important Difference of the American Orthopaedic Foot and Ankle Society Ankle Hindfoot Scale in Patients with Unstable Ankle Fracture.Clinics in orthopedic surgery · 2026Trial
- Co-design of a novel rehabilitation intervention for patients after ankle fracture surgery: establishing healthcare professional consensus.Musculoskeletal surgery · 2025Trial
- The minimal clinically important difference (MCID) of the Olerud Molander Ankle Score (OMAS) in patients with unstable ankle fracture.Archives of orthopaedic and trauma surgery · 2023Trial
- Cost-effectiveness of on-demand removal of syndesmotic screws.European journal of trauma and emergency surgery : official publication of the European Trauma Society · 2023Trial
- AO type C ankle fractures with additional posterior malleolus fragment: radiological and functional results of osseous reconstruction of the tibiofibular syndesmosis.European journal of orthopaedic surgery & traumatology : orthopedie traumatologie · 2026Article
- [Injuries of the tibiofibular syndesmosis].Unfallchirurgie (Heidelberg, Germany) · 2026Article
- Novel dynamic syndesmotic stabilization system improves anteroposterior and axial translation in distal tibiofibular joint.International orthopaedics · 2026Article
- Functional outcome in mini-fragment plating of the fibula in unstable ankle fractures.European journal of trauma and emergency surgery : official publication of the European Trauma Society · 2025Article
- Routine Removal of Syndesmotic Screws After Tibiofibular Syndesmosis Fixation Does Not Affect Patient Function and Is Associated with a Higher Risk of Postoperative Complications.Journal of clinical medicine · 2025Article
- Primary Ankle Fracture Dislocation Is Not a Negative Prognostic Factor for the Surgical Treatment of Syndesmotic Injury-A Retrospective Analysis of 246 Patients.Journal of clinical medicine · 2025Article
- Long-term Clinical Outcomes After Syndesmosis Fixation With K-wires in Ankle Fractures With Syndesmotic Instability.Foot & ankle orthopaedics · 2025Article
- Ankle fracture with syndesmotic injury treated by screw fixation: a prospective study on clinical and radiographic outcomes.Frontiers in surgery · 2025Article
- Is There Any Purpose in Routine Syndesmotic Screw Removal? Systematic Literature Review.Journal of clinical medicine · 2024Review
- Syndesmotic screws, unscrew them, or leave them? A systematic review and meta-analysis of randomized controlled trials.Journal of orthopaedics · 2024Review
- A comparison of screw and suture button fixation in the management of adolescent ankle syndesmotic injuries.Journal of children's orthopaedics · 2024Article
- [Injuries of the ankle ligaments].Orthopadie (Heidelberg, Germany) · 2024Article
- Current concepts in ankle fractures.Journal of clinical orthopaedics and trauma · 2023Review
- Predictors of Hardware Removal in Orthopaedic Trauma Patients Undergoing Syndesmotic Ankle Fixation With Screws.Foot & ankle orthopaedics · 2023Article
- "Flexible nature of fixation" in syndesmotic stabilization of the inferior tibiofibular joint affects the radiological reduction outcome.International orthopaedics · 2022Article
Corrections and comments
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Authors and funding
9 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
aimsThe aim of this study was to investigate whether on-demand removal (ODR) is noninferior to routine removal (RR) of syndesmotic screws regarding functional outcome.
methodsAdult patients (aged above 17 years) with traumatic syndesmotic injury, surgically treated within 14 days of trauma using one or two syndesmotic screws, were eligible (n = 490) for inclusion in this randomized controlled noninferiority trial. A total of 197 patients were randomized for either ODR (retaining the syndesmotic screw unless there were complaints warranting removal) or RR (screw removed at eight to 12 weeks after syndesmotic fixation), of whom 152 completed the study. The primary outcome was functional outcome at 12 months after screw placement, measured by the Olerud-Molander Ankle Score (OMAS).
resultsThere were 152 patients included in final analysis (RR = 73; ODR = 79). Of these, 59.2% were male (n = 90), and the mean age was 46.9 years (SD 14.6). Median OMAS at 12 months after syndesmotic fixation was 85 (interquartile range (IQR) 60 to 95) for RR and 80 (IQR 65 to 100) for ODR. The noninferiority test indicated that the observed effect size was significantly within the equivalent bounds of -10 and 10 scale points (p < 0.001) for both the intention-to-treat and per-protocol, meaning that ODR was not inferior to RR. There were significantly more complications in the RR group (12/73) than in the ODR group (1/79) (p = 0.007).
conclusionODR of the syndesmotic screw is not inferior to routine removal when it comes to functional outcome. Combined with the high complication rate of screw removal, this offers a strong argument to adopt on demand removal as standard practice of care after syndesmotic screw fixation. Cite this article:
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