New mesh may speed recovery from ankle instability surgery
NCT ID NCT06638138
First seen Jun 27, 2026 · Last updated Sep 02, 2026 · Updated 2 times
Summary
This study tested whether adding a synthetic mesh called Artelon FLEXBAND to standard ankle ligament surgery helps people with chronic ankle instability return to their normal activities sooner. Fifty-eight adults undergoing a modified Bröstrom procedure were randomly assigned to receive the mesh or surgery alone. Researchers tracked healing, safety, and function for up to two years after surgery.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Artelon FLEXBAND (a synthetic, degradable mesh used to reinforce ligament repair)
- What this could lead to
- If successful, this device could help people with chronic ankle instability return to their normal activities faster after surgery.
- What could go wrong
- This is a small, completed trial with only 58 participants, so results may not apply to everyone. Risks include infection, delayed healing, or need for additional surgery.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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58 people
The number who actually took part.
- Started
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Aug 2023
- Finished
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Dec 2025
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 75 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Subjects between and including the age of 18-75 at the time of surgery. 2. Subjects who were diagnosed with lateral ankle instability by physician clinical assessment. 3. Subjects who will undergo a modified Bröstrom procedure for an ATFL repair with or without FLEXBAND augmentation device (does not require an isolated repair). 4. Subjects that are able to understand, complete and sign the Consent Form. Exclusion Criteria: 1. Significant secondary procedures done at the time of repair, including significant osteochondral lesions and/or significant microfracture of the talus or tibia that warrant modifying the typical lateral ligament repair post-op rehab protocol (minor microfractures and OCD lesions that do not warrant major bone debridement, synovectomies, and bone spur/osteophyte removals are allowed). 2. Any concomitant orthopedic procedure that will extend the post-op rehabilitation (e.g., casting/immobilization) beyond the routinely prescribed rehab protocol following an ATFL reconstructive procedure. 3. Subjects undergoing a Calcaneal osteotomy. 4. Subjects requiring major additional tendon surgery (i.e., peroneal tendon repair or tenodesis). 5. Neuropathy. 6. Subjects with diabetes, who, in the opinion of the investigator, are not sufficiently controlled. 7. BMI greater than 40 kg/m2. 8. Subjects with active Worker's Compensation Cases 9. Any subject with a history of infection of the ankle predating the ankle repair. 10. Subjects with a systemic ligament laxity disorder (i.e., Ehlers-Danlos Syndrome). 11. Any orthopedic issue outside of the ankle that the Investigator feels may impede functional endpoint outcome measures. 12. Subjects who have a medical history that would likely make the subject an unreliable research participant. 13. Subjects that are nursing or pregnant at the time of surgery. 14. Subjects with physician assessed untreated alcohol or substance abuse at the time of screening. 15. Subjects who are currently enrolled or participated in another investigational device, drug, or biological trial within 60 days of screening.
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As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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MORE Foundation
Phoenix, Arizona, 85023, United States
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Medical University of South Carolina
Charleston, South Carolina, 29425, United States
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OrthoCarolina Research Institute
Charlotte, North Carolina, 28207, United States
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Orthopedic Foot and Ankle Center
Worthington, Ohio, 43085, United States
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Southeast Orthopedic Specialists
Jacksonville, Florida, 32204, United States
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The Center for Advanced Orthopedics
Falls Church, Virginia, 22042, United States
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UT Health Houson
Houston, Texas, 77030, United States
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University of Florida
Gainesville, Florida, 32607, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Rhythm and recovery: could music-like cues help badminton players bounce back from ankle sprains?
- Could a bioinductive implant strengthen ankle ligament repair?
- New implant may boost ankle surgery recovery
- Ankle surgery study pulled before it started: was routine arthroscopy a waste?
- Ankle tape study shows promise for chronic instability