Clinical trials: Syndesmotic Injuries
Ankle Fractures, Syndesmotic Injury of the Ankle
Dynamic Fixation for Complex Ankle Fractures With Syndesmotic Diastasis.
This prospective randomized controlled trial aims to evaluate the clinical effectiveness of dynamic fixation in patients with complex ankle fractures associated with syndesmotic diastasis.
- Trial name
- NCT07831265
- Testing
- the dynamic fixation, the screw fixation
- Volunteers
- 100 people
- Sponsor
- Fuzhou University Affiliated Provincial Hospital
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
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
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
Ankle Injuries, Syndesmotic Injuries
Comparing Clinical Outcomes of Suture Button Versus Fibulink Fixation for Acute Ankle Syndesmosis Injuries
This project consists of a randomized controlled study design. Study candidates will include all patients 18 years or older, who were evaluated at UCSD and found to have an acute ankle syndesmosis injury requiring surgery.
- Conditions
- Ankle Injuries, Syndesmotic Injuries, Ankle Fractures
- Trial name
- NCT05729542
- Testing
- Arthrex Tightrope, Synthes Fibulink
- Where
- United States
- Volunteers
- 140 people, healthy volunteers welcome
- Sponsor
- University of California, San Diego
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
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
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
Ankle Syndesmotic Injury Associated With Pott's Fracture
Correlation Between Ultrasound Findings Vs Intraoperative Findings in Syndesmotic Injury in Pott's Fracture Weber b and c
This study aims to assess and compare ultrasound findings, radiographic findings and intraoperative findings in cases of Pott's fractures weber types B and C to evaluate the accuracy of ultrasound in diagnosis of syndesmotic…
- Trial name
- NCT06945939
- Testing
- Fixation of Pott's fracture b and c
- Volunteers
- 20 people
- Sponsor
- Benha University
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, 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 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
Posterior Malleolus Fractures, Ankle Fractures
Weber B Ankle Fractures With Associated Posterior Malleolus Fracture
Ankle fractures constitute 9% of all fractures and have an incidence of approximately 187 per 100,000 persons per year in Norway.
- Conditions
- Posterior Malleolus Fractures, Ankle Fractures, Syndesmotic Injuries, Patient Reported Outcome Measure
- Trial name
- PMFIX (NCT05413707)
- Testing
- Fixation of the posterior malleolus fractures, Fixation of lateral and/or medial malleolus fractures, Syndesmotic fixation
- Where
- Norway
- Volunteers
- 198 people
- Sponsor
- Haukeland University Hospital
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
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
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 Injuries
Treatment of Syndesmotic Disruption With Anatomic Distal Tibiofibular Ligament Augmentation
The primary objective is to evaluate indications and outcomes of operative fixation of syndesmotic injuries, at least in part, with direct anatomic augmentation in acute and subacute traumatic cases.
- Trial name
- NCT04933045
- Testing
- Arthrex InternalBrace
- Where
- United States
- Volunteers
- 32 people
- Sponsor
- St. Clair Orthopaedics
Anke Fracture, Syndesmotic Injury
Routine Versus on Demand Removal of the Syndesmotic Screw
The objective of this trial is to demonstrate that the functional outcome of 'removal on demand' of the syndesmotic screw is non-inferior compared to routine removal of the syndesmotic screw in patients with an ankle fracture.
- Trial name
- RODEO (NCT02896998)
- Testing
- Removal on demand of the syndesmotic screw, Routine removal of fhe syndesmotic screw
- Where
- Netherlands
- Volunteers
- 197 people
- Sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
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