Clinical trials: Syndesmotic Injuries
Ankle Fractures, Syndesmotic Injury
Biodegradable Magnesium Screws for Unstable Ankle Fracture Surgery
Ankle fractures are among the most common injuries that need surgery. When the broken bones make the ankle unstable, surgeons usually fix them with metal screws and plates.
- Trial name
- NCT07693933
- Testing
- RemeOs Magnesium-Based Biodegradable Screw
- Where
- United States
- Volunteers
- 28 people
- Sponsor
- Massachusetts General Hospital
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
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
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
Syndesmotic Injury, Trimalleolar Fracture
Use of Bioresorbable Magnesium Set Screws in Syndesmotic Injuries: a Pilot Study
The primary aim of this prospective single-center pilot study is to evaluate the implant function of the bioresorbable magnesium set screw (ZX00) for the surgical fixation of the syndesmosis in isolated syndesmotic injuries as…
- Conditions
- Syndesmotic Injury, Trimalleolar Fracture, Bimalleolar Ankle Fracture, Osteosynthesis
- Trial name
- MgSyndesmose (NCT07901205)
- Where
- Austria
- Volunteers
- 20 people
- Sponsor
- Patrick Lukas Holweg, MD
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
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 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
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
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
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
Syndesmotic Injuries, Ankle Fractures
A Cohort Study of Bioabsorbable Screws for Syndesmosis Fixation Fixation in Ankle Fracture
The investigators aim to evaluate the fixation of the ankle syndesmosis in appropriate ankle fractures with bioabsorbable screws.
- Conditions
- Syndesmotic Injuries, Ankle Fractures, Ankle Injuries and Disorders
- Trial name
- Synfix (NCT05662449)
- Testing
- Syndesmosis fixation using Activascrew
- Where
- United Kingdom
- Volunteers
- 15 people, healthy volunteers welcome
- Sponsor
- NHS Grampian
Syndesmotic Injuries
Bilateral External Torque CT, a Novel Diagnostic Tool for Detection of Syndesmotic Insufficiency
Study population: the investigator set them sample size to 30 patients. Primary endpoint (concerning both study questions): is the applied torque measurement in Newton meters (maximum up to 7.5 Nm) up to the pain tolerance limit.
- Trial name
- NCT05625516
- Testing
- Bilateral external torque device
- Where
- Switzerland
- Volunteers
- 20 people
- Sponsor
- Balgrist University Hospital