Flexband for Lateral Ankle Sprain
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores the effectiveness and safety of returning to pre-injury activity levels after surgery for individuals with lateral ankle instability. Participants will undergo a modified Bröstrom procedure to repair a damaged ankle ligament, with some receiving additional support from the Artelon FLEXBAND device. The trial compares outcomes between those with the FLEXBAND and those without it. It is ideal for individuals diagnosed with lateral ankle instability who plan to have the specific ankle ligament surgery mentioned. As an unphased trial, this study offers participants the chance to contribute to valuable research that could improve future treatment options.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.
What prior data suggests that the Artelon FLEXBAND is safe for lateral ankle sprain repair?
Research shows that the Artelon FLEXBAND, used in ankle ligament repair, is generally well-accepted by patients. Studies have found that this device does not cause more negative side effects than traditional surgical methods. Specifically, patients using the FLEXBAND did not experience more problems than those who underwent standard surgery without it. The FLEXBAND stabilizes the ankle, aiding recovery and facilitating a return to normal activities. Overall, the safety information suggests that the FLEXBAND is a promising choice for those needing ankle ligament repair.12345
Why are researchers excited about this trial's treatment?
Unlike the standard of care for lateral ankle sprain, which typically involves ligament repair with anchors, the Artelon FLEXBAND offers an innovative twist. It uses a special augmentation technique during the modified Broström procedure, which could potentially enhance the stability and strength of the ATFL (anterior talofibular ligament). Researchers are excited about the FLEXBAND because it might improve healing outcomes and reduce the risk of future sprains by providing additional support that traditional methods don't offer.
What evidence suggests that the Artelon FLEXBAND is effective for lateral ankle sprain?
Research has shown that the Artelon FLEXBAND system can improve recovery after ankle surgery. In this trial, one group will undergo lateral ankle ligament repair using the modified Broström technique with Artelon FLEXBAND augmentation. The FLEXBAND is a strong material that mimics the natural strength of ankle tissues. Studies have found that using FLEXBAND can reduce pain immediately after surgery and help individuals return to daily activities more quickly. By providing extra support during healing, it may prevent ongoing issues like instability and pain. Overall, the FLEXBAND appears promising in enhancing ankle repairs and aiding faster patient recovery.12678
Who Is on the Research Team?
Rebecca Gibson
Principal Investigator
Stryker Trauma & Extremities
Are You a Good Fit for This Trial?
This trial is for individuals with lateral ankle instability who are planning to undergo a modified Bröstrom procedure to repair the anterior talofibular ligament (ATFL). Specific eligibility criteria details were not provided.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants undergo a modified Broström reconstruction procedure for repair of the ATFL, with or without Artelon FLEXBAND augmentation
Follow-up
Participants are monitored for safety and functional outcomes, including assessments like CAIT, FAAM, and pain medication usage
What Are the Treatments Tested in This Trial?
Interventions
- Artelon FLEXBAND
Find a Clinic Near You
Who Is Running the Clinical Trial?
Stryker Trauma and Extremities
Lead Sponsor