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
Trial Overview
The study compares two groups: one receiving the ARTELON FLEXBAND System as an augmentation device during ATFL reconstruction, and another undergoing the standard procedure alone. Outcomes will be tracked up to two years post-surgery.
How Is the Trial Designed?
2
Treatment groups
Active Control
This group will undergo a lateral ankle ligament repair using the modified Broström technique with Artelon FLEXBAND augmentation of the ATFL.
This group will undergo a lateral ankle ligament repair using the modified Broström technique. This technique utilizes anchors to repair the ATFL, in some cases the CFL, lateral ankle capsule and extensor retinaculum. This will be done without Artelon FLEXBAND augmentation.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Stryker Trauma and Extremities
Lead Sponsor
Citations
Study of Artelon FLEXBAND® for Patients Undergoing Soft ...
The goal of this clinical trial is to analzye return to pre-injury activity level on study participants with lateral ankle instability undergoing a modified ...
Patient Reported Outcomes from an Open Label, Multi ...
Surgical repair of the ATFL has relatively high success rates, however post-procedure chronic instability and pain remain a clinical challenge, with re- ...
Study of Artelon FLEXBAND® for Patients Undergoing Soft ...
The goal of this clinical trial is to analzye return to pre-injury activity level on study participants with lateral ankle instability undergoing a modified ...
Evaluation of a Biodegradable Synthetic Matrix for Lateral ...
Our results suggest that augmentation using a synthetic, woven PUUR matrix may lead to reduced early postoperative pain and an earlier transition to ...
The science behind Artelon's FLEXBAND technology.
Studies have shown suture repair alone may restore less than 50% of the tissue's original strength. The FLEXBAND biomaterial has a strength similar to ankle ...
An Open Label, Multi-center, Controlled, Retrospective ...
Surgical repair of ATFL has relatively high success rates, however post-procedure chronic instability and pain remain a clinical challenge, with re-operation ...
Evaluation of a Biodegradable Synthetic Matrix for Lateral ...
The PUUR matrix was safe with no difference in adverse events compared to a control group.
Native anterior talo-fibular ligament tensile characteristics ...
Early mobilization and accelerated rehabilitation following lateral ankle repair has been shown to result in improved functional outcomes [24.
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