Clinical trials: Syndesmotic Injuries
Ankle Fractures
Ziptight or Tricortical Screw Fixation of Acute Tibiofibular Syndesmotic Injury
Treatment of syndesmotic injury with Weber C fracture. A randomized study comparing ZipTight suture endobutton and one tricortical 3,5 mm syndesmotic screw.
- Trial name
- S16 (NCT02930486)
- Testing
- ZipTight suture endobutton, Tricortical 3.5 mm syndesmotic screw
- Where
- Norway
- Volunteers
- 120 people
- Sponsor
- Vestre Viken Hospital Trust
Syndesmotic Injuries
Randomized Controlled Trial Comparing Suture Button Versus Fibulink Fixation for Acute Ankle Syndesmosis Injuries
Ankle fractures are a common injury with potentially significant morbidity. Syndesmosis injury occurs in 10% to 13% of ankle fractures and poses a greater risk to long-term outcomes for patients.
- Trial name
- NCT05626036
- Testing
- Arthrex Tightrope, Synthes Fibulink
- Where
- United States
- Volunteers
- 50 people
- Sponsor
- United States Naval Medical Center, San Diego
Ankle Injuries
Investigation of Corticosteroid Versus Placebo Injection in Patients With Syndesmotic Ligament Injury or High Ankle Sprain
This study evaluates the use of corticosteroids acutely as an adjuvant treatment of the high ankle sprain. Subjects will receive either a corticosteroid or a local anesthetic injection.
- Trial name
- NCT02892500
- Testing
- bupivacaine hydrochloride and betamethasone sodium phosphate, bupivacaine hydrochloride
- Where
- United States
- Volunteers
- 1 people
- Sponsor
- Sanford Health
Syndesmotic Injury of the Ankle
Tightrope or Screw Fixation of Acute Tibiofibular Syndesmotic Injury
Syndesmotic injuries are common and often associated with unstable ankle fractures. The most common treatment is with a syndesmotic screw through the fibula and tibia which is later removed, usually after 10-12 weeks.
- Trial name
- TIGHTROPE-SS (NCT01275924)
- Testing
- Tightrope Syndesmosis Repair Kit, Syndesmotic screw
- Where
- 2 sites in Norway
- Volunteers
- 97 people
- Sponsor
- Sykehuset Asker og Baerum
Ankle Fractures, Ankle Fracture - Lateral Malleolus
Correlation Between Intraoperative Tourniquet Use and Limb pH, Functional Measures and Patient-reported Outcomes After Ankle Fracture Surgery
This study aims to 1) characterize skeletal muscle pH during/after tourniquet use and 2) investigate any relationship between intraoperative tourniquet use and postoperative functional measures and patient-reported outcomes.
- Conditions
- Ankle Fractures, Ankle Fracture - Lateral Malleolus, Ankle Fracture, Bimalleolar, Ankle Fracture, Trimalleolar
- Trial name
- NCT05445960
- Testing
- Tourniquet
- Where
- United States
- Volunteers
- 390 people
- Sponsor
- Oregon Health and Science University
Trauma
Screw Versus Tightrope Syndesmotic Injury Fixation in Weber C Ankle Fractures
The aim of our study is to compare two different syndesmosis transfixation methods in AO/OTA Weber C ankle fractures. Our hypothesis is that 50% of screw fixed fibulas but only 5% of suture-button fixed fibulas are in…
- Trial name
- NCT01742650
- Testing
- Screw fixation, TightRope
- Where
- Finland
- Volunteers
- 38 people
- Sponsor
- University of Oulu
Displaced Ankle Fractures
Assessment of Ability of 3D Fluorscopy in Aiding Accurate Syndesmotic Reduction Following Traumatic Ankle Injury
The purpose of this study is to determine if use of new imaging technology termed "3D fluoroscopy" will lead the surgeon to change the position of the fractured bones to a more accurate position.
- Trial name
- NCT03163017
- Testing
- 2D Fluoroscopy, 3D Fluoroscopy
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- The University of Texas Health Science Center, Houston
Ankle Injuries, Syndesmotic Injuries
Grappler® Interference Screw Post-Market Clinical Follow-Up Study
Ambispective, multi-surgeon, single site, consecutive case series to determine the safety, performance, and benefits of the Grappler(R) Interference Screw.
- Conditions
- Ankle Injuries, Syndesmotic Injuries, Ankle Inversion Sprain, Deltoid Ankle Sprain
- Trial name
- NCT04893824
- Testing
- Grappler® Interference Screw System
- Where
- United States
- Volunteers
- 50 people
- Sponsor
- Paragon 28
Trimalleolar Fracture, AO Weber C Fractures
Fixation of the Posterior Malleolus in Trimalleolar AO Weber C Fractures.
In AO Weber type C fractures, there is a combination of a proximal fibular fracture, a medial fracture or ruptured deltoid ligament, and a syndesmotic injury.
- Conditions
- Trimalleolar Fracture, AO Weber C Fractures, Syndesmotic Stability, Open Reduction and Internal Fixation
- Trial name
- POSTFIX-C (NCT02599285)
- Testing
- Fixation, NO Fixation
- Where
- 4 sites in Netherlands
- Volunteers
- 54 people
- Sponsor
- Medical Center Haaglanden
Ankle Fractures, Syndesmotic Injuries
Effects of Postoperative Kinesio Taping in Weber Type B Lateral Malleolar Fractures
This randomized controlled trial aimed to evaluate the effects of postoperative Kinesio taping on pain, range of motion, and edema in patients undergoing surgical fixation for Weber type B lateral malleolar fractures.
- Conditions
- Ankle Fractures, Syndesmotic Injuries, Postoperative Rehabilitation
- Trial name
- KT-WeberB (NCT06958133)
- Testing
- Standard Postoperative Rehabilitation, Kinesio Taping
- Where
- Turkey (Türkiye)
- Volunteers
- 32 people
- Sponsor
- Fatih Sultan Mehmet Training and Research Hospital
Trauma
Syndesmotic Injury and Fixation in Supination-External (SE) Ankle Fractures
The aim of our study was to determine whether transfixation of unstable syndesmosis is necessary in supination-external rotation type ankle fractures.
- Trial name
- NCT01234493
- Testing
- fixation, no fixation
- Where
- Finland
- Volunteers
- 140 people, healthy volunteers welcome
- Sponsor
- University of Oulu
Ankle Injuries, Syndesmotic Injuries
Comparison of Screw and Suture Button Technique Results in Ankle Syndesmosis Injuries
In this study, syndesmosis injuries were detected in 143 of the patients who came to Atatürk University Faculty of Medicine, Orthopedics and Traumatology clinic from October 2017 to October 2021 with ankle fractures.
- Conditions
- Ankle Injuries, Syndesmotic Injuries, Tibiofibular; Dislocation Distal
- Trial name
- NCT05538845
- Testing
- Screw fixation, Suture button
- Where
- Turkey (Türkiye)
- Volunteers
- 110 people
- Sponsor
- Ataturk University
Syndesmotic Injuries
Syndesmotic Screw in Neutral Position Versus Maximum Ankle Dorsiflexion in Ankle Fractures; Comparative Study.
Ankle fracture is one of the most common orthopedic injuries. Approximately, 20% of surgically treated ankle fractures are associated with syndesmotic instability.According to the mechanism of the injury the syndesmotic…
- Trial name
- NCT06313177
- Testing
- syndesmosis fixation with screws
- Where
- Egypt
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Sohag University
Ankle Injuries, Syndesmotic Injuries
Grappler Interference Screw Post-Market Collection of Patient Reported Outcome Measures
Ambispective, multi-surgeon, single site, consecutive case series to determine the safety, performance, and benefits of the Grappler(R) Interference Screw.
- Conditions
- Ankle Injuries, Syndesmotic Injuries, Ankle Inversion Sprain, Deltoid Ankle Sprain
- Trial name
- NCT05190874
- Testing
- Grappler Interference Screw System
- Where
- United States
- Volunteers
- 19 people
- Sponsor
- Paragon 28
Ankle (Ligaments); Instability (Old Injury), Ankle Ligament Rupture
French Ankle Ligament Surgery Cohort Study
This 20-year cohort study foolows patients after ankle ligament reconstruction surgery to evaluate re-rupture rates, long term functional outcomes, return to sport rates ans complications? The goal is to provide insights into the…
- Conditions
- Ankle (Ligaments); Instability (Old Injury), Ankle Ligament Rupture, Ankle Instability, Syndesmotic Injury
- Trial name
- AnkleCDS (NCT07188363)
- Testing
- Ligament reconstruction
- Where
- France
- Volunteers
- 5,000 people
- Sponsor
- Chirurgie Du Sport
Ankle Fractures, Bimalleolar Fractures
Fibulink Syndesmosis Repair System With Early Full-Weight Bearing
The purpose of the study is to evaluate the ability of the Fibulink Syndesmosis Repair System to maintain reduction of the ankle syndesmosis.
- Conditions
- Ankle Fractures, Bimalleolar Fractures, Syndesmotic Injuries, Bimalleolar Equivalent Fracture
- Trial name
- NCT06085586
- Testing
- Early Weight Bearing, Normal Weight Bearing
- Where
- United States
- Volunteers
- 56 people, healthy volunteers welcome
- Sponsor
- Maimonides Medical Center
Lateral Malleolus Fractures, Ankle Fractures
Weight-bearing Radiographs to Evaluate Stability in Ankles With Isolated Weber Type B Fractures.
The investigators will conduct a prospective cohort study on the use of weight-bearing radiographs to evaluate stability in ankles with isolated, trans-syndesmotic (Weber type B) fibular fractures.
- Trial name
- NCT03831009
- Testing
- Open reduction internal fixation (ORIF), Conservative treatment
- Where
- Norway
- Volunteers
- 151 people
- Sponsor
- Ostfold Hospital Trust
Syndesmotic Injuries, Ligament Rupture
Internal Brace Augmented Anterior Inferior Tibiofibular Ligament Repair: Post-operative Syndesmotic Volumes.
Over the course of a year from the start of the research study, twenty subjects will be randomized evenly into one of two groups after an informed consent is obtained: a traditional tight rope fixation group or a tight rope…
- Conditions
- Syndesmotic Injuries, Ligament Rupture, Bimalleolar Fractures, Trimalleolar Fractures
- Trial name
- NCT05062265
- Testing
- Tight rope fixation, Tight rope fixation with an anterior inferior tibiofibular ligament (AITFL) repair augmentation with an internal brace
- Where
- United States
- Volunteers
- 23 people, healthy volunteers welcome
- Sponsor
- Vann Virginia Center for Orthopaedics dba Atlantic Orthopaedic Specialists
Ankle Fractures
Postoperative Computed Tomography Detection of Syndesmotic Malreduction in Ankle Fractures
This prospective observational cohort study aims to evaluate the ability of postoperative plain radiographs to detect syndesmotic reduction accuracy in patients with ankle fractures requiring syndesmotic fixation.
- Trial name
- NCT07338149
- Where
- Egypt
- Volunteers
- 86 people
- Sponsor
- Cairo University
Ankle Fractures, Osteoarthritis, Ankle
Stability of Distal Tibiofibular Syndesmosis With or Without Fixation of Posterior Fragments in Bimalleolar Fractures
Background and Rationale: Injury to the tibiofibular syndesmosis in ankle fractures is a major prognostic factor for the development of post-traumatic osteoarthritis.
- Trial name
- SYNDESMOSE (NCT07755462)
- Testing
- Surgical management of bimalleolar ankle fractures with osteosynthesis of the posterior fragments., Surgical management of bimalleolar ankle fractures without osteosynthesis of the posterior fragments
- Where
- France
- Volunteers
- 150 people
- Sponsor
- Groupe Hospitalier Diaconesses Croix Saint-Simon