SLR - March 2022 - Zachary P. Hill
Reference: Sanders FRK, Birnie MF, Dingemans SA, van den Bekerom MPJ, Parkkinen M, van Veen RN; RODEO collaborator group, Goslings JC, Schepers T. Functional Outcome of Routine Versus On-Demand Removal of the Syndesmotic Screw: A Multicentre Randomized Controlled Trial. Bone Joint J. 2021 Nov;103-B(11):1709-1716.Level of Evidence: Level II
Scientific Literature Review
Reviewed By: Zachary P. Hill, DPM
Residency Program: Grant Medical Center – Columbus, OH
Podiatric Relevance: Syndesmotic injuries accompany ankle fractures approximately 15-20 percent of the time. Surgically, these injuries can be addressed with syndesmotic screw fixation for added stability. The traditional approach has been removal of syndesmotic fixation at eight to twelve weeks. The rationale behind the removal of syndesmotic fixation is that, if left in situ, it will hinder ankle function and cause pain as the patient begins to fully bear weight. Some find the removal of syndesmotic fixation unnecessary unless causing pain. The purpose of this study is to investigate whether on-demand removal (ODR) is non-inferior to routine removal (RR) of syndesmotic screws regarding the functional outcome.
Methods: This is a multicenter randomized control trial comparing ODR (retained unless there were complaints) and RR (removed at 8-12 weeks) of surgically placed syndesmotic screws. Adult patients sustaining a traumatic syndesmotic injury treated surgically with one or two syndesmotic screws within two weeks of injury were included in this study. One hundred ninety-seven (197) patients were randomized for ODR or RR, with 152 patients completing the trial. The primary outcome measure was functionality, measured via the Olerud-Molander Ankle Score (OMAS), twelve months after syndesmotic screw placement. OMAS includes subjective outcome measures with a scale of 0-100. Higher scores equate to higher function. Secondary outcome measures were the American Orthopaedic Foot and Ankle Hindfoot Score (AOFAS), Visual Analogue Scale (VAS), and active range of motion. All outcomes were measured at three, six and twelve months post-operatively for both groups.
Results: A total of 152 patients were randomized and completed the trial (73 RR, 79 ODR). The median OMAS at twelve months was 85 (85/100) for the RR group and 80 (80/100) for the ODR group. A non-inferiority test was performed for both groups and showed that the ODR method was not inferior to RR method. Additionally, AOFAS, VAS pain scores, and range of motion did not significantly differ between the groups. Significantly more complications occurred in the RR group (12/73) when compared to the ODR group (1/79). Complications included wound dehiscence (n=5), superficial surgical site infection (n=2), deep surgical site infection (n=2), diastasis after removal (n =1), synovitis (n=1) and stiffness (n=1).
Conclusions: It is important as a foot and ankle community to continuously investigate traditional approaches to surgery and adapt based on literature. The ODR method for removal of syndesmotic screws was found to be non-inferior to routine removal in terms of functional outcome, contrary to previous thoughts and recommendations. Additionally, no significant differences were found in regards to pain or range of motion between the groups at each stage of follow-up. These findings, along with a relatively high complication rate in the RR group, offer a sound justification to incorporate the ODR method into everyday practice as a foot and ankle surgeon. This study had a relatively short follow-up period of 12 months, thus it would be beneficial to be cognizant of similar studies with longer follow-up to make more definitive conclusions.