SLR - December 2016 - Kevin Renner

A Prospective Randomized Multicenter Trial Comparing Clinical Outcomes of Patients Treated Surgically with a Static or Dynamic Implant for Acute Ankle Syndesmosis Rupture

Reference: Laflamme M, Belzile EL, Bédard L, van den Bekerom MP, Glazebrook M, Pelet S. A Prospective Randomized Multicenter Trial Comparing Clinical Outcomes of Patients Treated Surgically With a Static or Dynamic Implant for Acute Ankle Syndesmosis Rupture. J Ortho Trauma. 2015 May;29(5):216–23

Scientific Literature Review

Reviewed By:
Kevin Renner, DPM
Residency Program: Grant Medical Center

Podiatric Relevance: Ankle fractures with syndesmotic instability are commonly seen in the foot and ankle surgeon’s practice. It is important for the surgeon to not only be able to recognize these injuries, but to also know the best treatment options for the individual patient. Traditionally, one or two tricortical or quadcortical screws are used for syndesmotic fixation. However, screws may not allow for proper physiologic motion needed across the syndesmosis. Additionally, screw breakage is not uncommon. This study provides good evidence for another method of fixation of the syndesmosis that allows dynamic range of motion and improved clinical and radiographic outcome scores. I believe this study should give foot and ankle surgeons confidence in a suitable and possibly better alternative to traditional screw fixation of syndesmotic injuries.    

Methods: A Prospective Randomized Multicenter Trial included 65 subjects at five trauma centers. All patients were aged 18 to 65 with an acute ankle fracture and syndesmotic instability. Exclusion criteria were polytrauma, neurological impairment, obesity and inability to participate in postoperative rehabilitation. All subjects were randomized into a dynamic (Arthrex TightRope) or static fixation (3.5 screws). Patients and evaluators were blinded until the end of the study. Static fixation was performed with a 3.5 quadcortical screw 2 cm proximal to the ankle joint. Dynamic fixation was also performed 2 cm proximal to the ankle joint per technique guide. Only one screw or TightRope was used in each case. Postoperative rehabilitation was the same in each group and consisted of nonweightbearing in a cast for six weeks, after which progressive weightbearing was initiated. The primary outcome measure was the Olerud-Molander score, which is the only reliable validated score for ankle fractures in the literature. This score and all clinical evaluations were done at three, six and 12 months. Secondary outcome measures included the AOFAS, VAS, radiographic evaluation and time to return to activity.

Results: Subjects with dynamic fixation achieved better clinical performances on the Olerud-Molander scores at three, six and 12 months. Additionally, AOFAS scores were higher in the dynamic group at three months but were not significant at six and 12 months. Furthermore, implant failure was higher in the static group (36.1 percent vs. 0 percent). Finally, loss of reduction was observed in four cases in the static group, while there were none in the dynamic group.

Conclusion: In this study, the dynamic fixation of acute ankle syndesmosis rupture with the TightRope gives better clinical and radiographic outcomes than the static fixation with one 3.5 mm quadcortical screw. The implant offers adequate syndesmotic stabilization without breakage or loss of reduction and a lower reoperation rate. 

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