Flexband for Lateral Ankle Sprain

Recruiting at 7 trial locations

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Stryker Trauma and Extremities

Disqualifiers: Diabetes, Neuropathy, BMI > 40, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

Duration: Surgery day

92 Participants Needed

Trial Summary

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 makes the treatment Artelon FLEXBAND unique for lateral ankle sprain?

The Artelon FLEXBAND treatment is unique because it likely involves a novel mechanism of action using flex-activated mechanophores, which are materials that respond to mechanical stress by selectively breaking and reforming covalent bonds. This approach could potentially enhance the treatment's effectiveness by allowing targeted and controlled release of therapeutic agents in response to the mechanical forces experienced by the ankle. ^{1 2 3 4 5}

What is the purpose of this trial?

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 Bröstrom reconstruction procedure for repair of the ATFL. Study participants undergoing ATFL reconstructive procedure using the ARTELON FLEXBAND System as an augmentation device will be compared to study participants undergoing a standard modified Bröstrom procedure alone. Clinician reported safety and functional outcomes measures will be collected at baseline; and at 2-, 6-, 12-, 18 and 26-weeks and 1- and 2-years post-surgery.

Research Team

Rebecca Gibson

Principal Investigator

Stryker Trauma & Extremities

Eligibility Criteria

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

Subjects able to understand, complete and sign the Consent Form

My doctor diagnosed me with lateral ankle instability.

I am having a surgery to repair my ankle ligament, possibly with a special device.

Exclusion Criteria

Subjects with active Worker's Compensation Cases

My diabetes is not well-controlled.

I do not have significant nerve pain or damage.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo a modified Broström reconstruction procedure for repair of the ATFL, with or without Artelon FLEXBAND augmentation

Surgery day

1 visit (in-person)

Follow-up

Participants are monitored for safety and functional outcomes, including assessments like CAIT, FAAM, and pain medication usage

2 years

Visits at 2, 6, 12, 18, 26 weeks, and 1 and 2 years post-surgery

Treatment Details

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.

Participant Groups

Group I: FLEXBAND Active Control 1 Intervention

This group will undergo a lateral ankle ligament repair using the modified Broström technique with Artelon FLEXBAND augmentation of the ATFL.

Group II: Control Active Control 1 Intervention

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.

Who Is Running the Clinical Trial?

Stryker Trauma and Extremities

Lead Sponsor

Trials

57

Recruited

14,900+

References

1. Germany pubmed.ncbi.nlm.nih.gov

The Mechanism of Flex-Activation in Mechanophores Revealed By Quantum Chemistry. [2023]

2. Germany pubmed.ncbi.nlm.nih.gov

Mechanochemical Release of Fluorophores from a "Flex-activated" Mechanophore. [2023]

3. England pubmed.ncbi.nlm.nih.gov

Mechanically induced chemiluminescence from polymers incorporating a 1,2-dioxetane unit in the main chain. [2021]

4. England pubmed.ncbi.nlm.nih.gov

Mechanochromic luminescent property of a polypeptide-based dendron. [2011]

5. England pubmed.ncbi.nlm.nih.gov

Force-induced activation of covalent bonds in mechanoresponsive polymeric materials. [2021]