SLR - January 2020 - Keegan Duelfer
Reference: Sanders D, Schneider P, Taylor M, Tieszer C, Lawendy AR. Improved Reduction of the Tibiofibular Syndesmosis with TightRope Compared with Screw Fixation: Results of a Randomized Controlled Study. J Ortho Trauma. 2019 Nov; 33(11)Scientific Literature Review
Reviewed By: Keegan Duelfer, DPM
Residency Program: Regions/ HealthPartners – St. Paul, MN
Podiatric Relevance: The adverse effects of syndesmosis malreduction of as little as 2 mm on clinical outcomes is becoming increasingly recognized. The purpose of this study was to compare the functional and radiographic outcomes of open reduction and internal fixation of syndesmosis injuries using either the TightRope device or screw fixation.
Methods: A prospective randomized controlled study was undertaken, which involved 103 patients with demonstrated radiographic syndesmosis diastasis or instability after malleolar bony fixation. The patients were followed for 12 months post operatively.
The primary outcome of this study was the rate of malreduction based on bilateral ankle CT scan results at three months after fixation. Malreduction was defined as 2mm translation or 10-degree rotation. Secondary outcomes of this study were adverse events, reoperation and functional outcomes. The validated functional outcomes in this study included EQ-5D, the Olerud-Molander Ankle Score, the Foot and Ankle Disability Index, and the Work Productivity Activity Impairment Questionnaire.
Results:
Rate of malreduction (P= 0.028):
•Screw fixation: 39 percent
•TightRope fixation: 15 percent
Reoperation rate (P= 0.02):
•Screw Fixation: 30 percent
•TightRope fixation: 4 percent
Adverse events:
• Seven cases of screw irritation, two loss of reduction (one screw, oneTightrope), one deep infection in TightRope
Functional outcomes:
•Significant improvements over time, but no differences between fixation groups
Conclusions:
Author’s conclusion: TightRope device seems to compare favorably with two, 3.5-mm, three-cortex screw fixation for syndesmosis injuries.
Reviewer’s conclusion: TightRope fixation device provides adequate reduction with relatively low re-operation rates and good functional outcomes; however, further unsponsored research should be performed before declaring its superiority over other fixation methods.
Limitations: This clinical trial was funded through a competitive grant process administered through the Orthopaedic Trauma Association and sponsored by Arthrex. Rate of malreduction based on non-weightbearing CT scans which may provide adequate representation of functional ankle joint.
Clinical utility:
•TightRope fixation appears to have slightly better radiographic outcomes and very similar functional outcomes when compared to more traditional screw fixation.
•Re-operation rate for TightRope fixation appears to have lower operation rates than screw fixation which may help to offset its more expensive cost.