Abstract
BackgroundAnkle sprains and fractures are most common injuries in orthopedic and trauma surgery. The concurrent occurrence of syndesmosis ruptures in these injuries represents a more complex problem, as they often remain undetected.A proper and accurate treatment of injuries of the syndesmosis, both isolated and combined with fractures, is necessary to avoid long-term consequences (chronic instability, cartilage damage, and post-traumatic osteoarthritis). The most popular treatment option is a static screw fixation and the newly developed dynamic TightRope® (Arthrex, Naples, FL, USA).The aim of this pilot study is to compare monitor ankle range of motion and maximum ankle power in gait as functional outcome parameters of instrumented gait analysis, as well as clinical and radiographic outcome for assessing the stabilization of acute syndesmosis rupture with either a static implant (a 3.5 mm metallic screw) or a dynamic device (TightRope®).MethodsThis prospective, randomized, controlled, clinical trial will be carried out at the Center for Orthopedics, Trauma Surgery and Spinal Cord Injury of the University Hospital Heidelberg. Adult patients, who suffer from an acute syndesmosis rupture, both isolated and in combination with fractures of the lateral malleolus (Weber C and Maisonneuve fractures) and who are undergoing surgery at our trauma center will be included in our study. The patients will be randomized to the different treatment options (screw fixation or “TightRope®”). Subsequent to the surgical treatment, all patients will receive the same standardized follow-up procedures including a gait analysis and MRI of the ankle at 6 months follow-up.The primary endpoint of the study is the successful healing of the syndesmosis and biomechanical investigation with gait analysis.DiscussionThe results of the gait analysis from the current study will help to impartially and reliably evaluate the clinical and biomechanical outcome of both treatment options of acute syndesmosis ruptures. We hypothesize that the dynamic fixation provides an equivalent or better biomechanical, clinical, and radiographic outcome in comparison to the screw fixation.Trial registrationGerman Clinical Trials Register (DRKS) DRKS00013562. Registered on July, 12, 2017.
Highlights
Ankle sprains and fractures are most common injuries in orthopedic and trauma surgery
This study focuses mainly on the treatment of syndesmosis rupture, but it aims to gain insights into patients’ satisfaction in correlation to functional outcome and surgical technique
A self-designed questionnaire as well as the “Score of Olerud und Molander (OMAS)” [20] and “Foot and ankle outcome score (FAOS)” [27] will be used to evaluate the range of motion, deficits in daily life, symptoms after ankle fractures and after surgical treatment, and socioeconomic factors. The objective of this prospective randomized controlled single-center study is the comparison of the gait analysis, clinical and radiographic outcome after stabilization of an acute syndesmosis rupture with either a static implant (a 3.5-mm metallic screw through three cortices) or a dynamic device (TightRope®)
Summary
Ankle sprains and fractures are most common injuries in orthopedic and trauma surgery. The concurrent occurrence of syndesmosis ruptures in these injuries represents a more complex problem, as they often remain undetected. The most popular treatment option is a static screw fixation and the newly developed dynamic TightRope® (Arthrex, Naples, FL, USA) The aim of this pilot study is to compare monitor ankle range of motion and maximum ankle power in gait as functional outcome parameters of instrumented gait analysis, as well as clinical and radiographic outcome for assessing the stabilization of acute syndesmosis rupture with either a static implant (a 3.5 mm metallic screw) or a dynamic device (TightRope®). The syndesmosis ligament connects the tibia and the fibula above the ankle joint. It is, among other ligaments, responsible for its stabilization. Tibiofibular clear space greater than 6 mm (diastasis) in AP X-ray view is considered as a radiologic criterion for instability
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