Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05729542
Other study ID # 800669
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date November 18, 2021
Est. completion date November 18, 2027

Study information

Verified date May 2024
Source University of California, San Diego
Contact Dominic Baun, MS
Phone 858-534-8268
Email jbaun@health.ucsd.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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. Patients who consent to study participation will be randomized to receive one of two standard of care procedures - either a suture button or Fibulink implant. Outcome measures, including the Olerud-Molander and American Orthopaedic Foot and Ankle Society scores, pain, range of motion, time to return to work, and radiographic evaluation will be collected for each participant. Given the potential degenerative changes and poor radiographic and clinical outcomes with inadequate repair of the syndesmosis, it is imperative to evaluate existing and emerging methods of fixation for patients with acute ankle fractures with syndesmosis injuries.


Recruitment information / eligibility

Status Recruiting
Enrollment 140
Est. completion date November 18, 2027
Est. primary completion date November 18, 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Ankle fracture with associated syndesmotic injury requiring surgery - Age 18 years or older - Ability to understand the content of the patient information/informed consent form Exclusion Criteria: - Any not medically managed severe systemic disease - Patient preference for specific implant - Refusal of randomization - Pregnant patients - Prisoners - Participation in any other pharmacologic or medicinal product study within the previous month that could influence the results of this study

Study Design


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
University of California, San Diego

Outcome

Type Measure Description Time frame Safety issue
Primary Visual Analog Scale (VAS) Pain score VAS Pain score is rated from 0-10, 0=no pain and 10=most severe pain 1 year
Primary Foot and Ankle Disability Index Functional score with a 0-104 with higher scores indicating better function 1 year
Primary Olerud-Molander Ankle Score Functional Score with a score of 0-100 with higher scores indicating better function 1 year
Secondary Number of participants with medical or surgical complications Medical and surgical complications to include: surgical site infection, re-operation, device failure, loss of motion 1 year
See also
  Status Clinical Trial Phase
Recruiting NCT05555459 - Performance and Safety Evaluation of Inion CompressOn Screw in Foot and Ankle Surgeries. PMCF Investigation N/A
Completed NCT04235907 - Telerehabilitation Following Ankle Fractures N/A
Completed NCT02949674 - Ropivacaine Versus Bupivacaine as Preemptive Analgesia in Surgical Site in Ankle Fracture Patients Phase 3
Completed NCT02198768 - Ankle Fracture vs Ankle Fracture-Dislocation
Recruiting NCT05916300 - Diagnostic Ultrasonography in Physiotherapy
Recruiting NCT04674046 - Deep Deltoid Ligament Integrity in Weber B Ankle Fractures - Mini-invasive Arthroscopic Evaluation. N/A
Recruiting NCT03696199 - Randomized Controlled Trial for Ankle Fracture Pain Control Phase 4
Recruiting NCT03259204 - Swedish Multicenter Trial of Outpatient Prevention of Leg Clots N/A
Not yet recruiting NCT03625154 - Operative Versus Non Operative Management Outcomes of Isolated Lateral Malleolar Weber B Ankle Fractures N/A
Active, not recruiting NCT03769909 - Prevention of Posttraumatic Osteoarthritis After Acute Intraarticular Fractures
Recruiting NCT05280639 - Simplified Post Op Rehabilitation for Ankle and Pilon Fractures N/A
Completed NCT02967172 - Efficacy of Multimodal Periarticular Injections in Operatively Treated Ankle Fractures Phase 4
Withdrawn NCT04768478 - CBD for Pain Reduction and Opioid Use After Ankle and Tibia Fracture ORIF Phase 4
Completed NCT05084794 - The Results of Middle-sized Posterior Malleolus Fractures: Fixed Versus Non-fixed N/A
Completed NCT03741556 - Prognostic Factors Following Ankle Fractures
Active, not recruiting NCT02481076 - Compression in Anklefracture Treatment, The CAT-study N/A
Not yet recruiting NCT06086223 - Functional Outcomes Following Ankle Fracture Fixation With or Without Ankle Arthroscopy N/A
Recruiting NCT05389436 - Outpatient Versus Inpatient Surgery for Ankle Fractures N/A
Not yet recruiting NCT06329752 - Sciatic Nerve Block for Ankle and Leg Fracture Manipulation in the Emergency Department N/A
Recruiting NCT05391464 - Nerve Block for Pain Control After Fracture Surgery N/A