ATFLNCT07401095
BioBrace® in Arthroscopic Brostrom Lateral Ankle Ligament Repair
A study testing Brostrom repair with augmentation and Brostrom repair without augmentation in people with ATFL and Lateral Ankle Instability, run by Hancock Orthopedics at 1 site in United States.
Trial summary
The purpose of this investigation is to evaluate pre- and post-operative patient reported outcomes and functional scores after an all-arthroscopic Brostrom repair using either a suture anchor construct alone or suture anchors with the BioBrace Implant. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- ATFL, Lateral Ankle Instability, Anterior Talofibular Ligament
- What is being tested?
- Brostrom repair with augmentation and Brostrom repair without augmentation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Dec 2025to Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- At least 18 years of age at the time of surgery.
- Able to read, understand and sign the informed consent form.
- Willing to be available to attend each protocol required visit and complete the study required questionnaires.
- Scheduled to undergo primary, arthroscopic Brostrom repair.
Who cannot join
- Previous Brostrom surgery.
- Concomitant procedures that would change the post operative course/recovery (i.e. total ankle replacement, OCD repair, foot/ankle osteotomies) as determined by the Investigator.
- Currently participating or plans to enroll in another clinical trial during this study that would affect the outcomes of this study as determined by the Investigator.
- History of non-compliance with medical treatment or clinical trial participation.
- The subject is physically or mentally compromised (e.g., currently being treated for a psychiatric disorder, senile dementia, Alzheimer's disease, etc.), to the extent that the Investigator judges the subject to be unable or unlikely to remain compliant with protocol required follow-up.
- Females of child-bearing potential who are either pregnant or breastfeeding or plan to become pregnant during the course of the study.
- Any comorbidity or condition that renders the patient a poor surgical candidate as determined by the Investigator.
- Hypersensitivity to any investigational device materials including collagen of animal origin (bovine type-I), poly-L-lactic acid (PLLA) or polyethylene glycol (PEG)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Hancock Orthopedics
Greenfield, Indiana, 46140
Jay Badell, DPM, MS, FACFAS, 317-477-6683, JBadell@hancockhealth.org
About this study
Official title: Early Outcomes With and Without Use of a Novel Reinforced Bioinductive Implant in Arthroscopic Brostrom Repair: A Prospective Randomized Study
The purpose of this investigation is to evaluate pre- and post-operative patient reported outcomes and functional scores after an all-arthroscopic Brostrom repair using either a suture anchor construct alone or suture anchors with the BioBrace Implant.
Read the detailed description
This is a single-center, prospective, randomized (1:1) interventional study investigating the use of the BioBrace® Implant in lateral ankle ligament repair procedures performed using an all-arthroscopic Broström technique. Eligible participants who meet study criteria will be enrolled and randomized into one of two study arms:
Control Group: Arthroscopic Broström repair using a suture-anchor construct only.
Treatment Group: Arthroscopic Broström repair using a suture-anchor construct augmented with the BioBrace® Implant.
Clinical evaluations will be conducted at baseline (preoperatively), and postoperatively at 1, 3, and 6 weeks, as well as at 3, 6, and 12 months using various patient-reported outcome measures to asses pain, function, activity and safety post surgery.
- Conditions
- ATFL, Lateral Ankle Instability, Anterior Talofibular Ligament, Anterior Talofibular Ligament Injury, Brostrom Procedure, Brostrom
- Being tested
- Brostrom repair with augmentation, Brostrom repair without augmentation
- Keywords
- BioBrace, The BioBrace Implant, BioBrace Implant, ATFL, Lateral Ankle Instability, CONMED, Ankle, Ankle Injury
- Medical subject headings
- Ankle Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brostrom repair with augmentationDevice
Brostrom repair with BioBrace
Brostrom repair without augmentationOther
Brostrom repair without BioBrace
| Study group | Role | What they receive |
|---|---|---|
| Control - Repair Only Group | Sham comparator | Procedure: Standard of care Brostrom repair. Receives: Other: Brostrom repair without augmentation |
| BioBrace Augment Group | Experimental | Brostrom repair with BioBrace Receives: Device: Brostrom repair with augmentation |
What is being measured
The primary outcome is the main question the study is designed to answer.
American Orthopedic Foot and Ankle Society score (AOFAS)
The AOFAS Score is a clinician-based assessment tool that evaluates pain, function, and alignment in patients with foot and ankle disorders. It provides a composite score ranging from 0 to 100, with higher scores indicating better function. The system includes region-specific scales (e.g., ankle-hindfoot, midfoot, hallux) and combines both patient-reported symptoms and objective clinician findings
Measured: Baseline, 1, 3, and 6 weeks & 3, 6, and 12 months
Foot Function Index (FFI)
The Foot Function Index (FFI) is a patient-reported questionnaire used to assess how foot conditions affect pain, disability, and activity limitation. It includes 23 items rated on a 0-10 scale, with higher scores indicating greater impairment in foot function.
Measured: Baseline, 1, 3, and 6 weeks & 3, 6, and 12 months
Visual Analog Scale (VAS)
The Visual Analog Scale (VAS) is a tool used to measure the intensity of pain or other subjective symptoms. It consists of a 10-cm line labeled "no pain" at one end and "worst imaginable pain" at the other; patients mark their pain level on the line, which is then measured to provide a numerical score from 0 to 100.
Measured: Baseline, 1, 3, and 6 weeks & 3, 6, and 12 months
Karlsson-Peterson score
The Karlsson-Peterson Score is a functional ankle assessment tool that evaluates symptoms such as pain, swelling, instability, stiffness, stair-climbing ability, running ability, work/activity level, and need for support, producing a total score up to 100, with higher scores indicating better ankle function.
Measured: Baseline, 1, 3, and 6 weeks & 3, 6, and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2026
- Study start8 Dec 2025
- Primary completionJun 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ATFLStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 1:1 randomization
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hancock Orthopedics
- Sponsor type
- University, hospital or other
- Collaborators
- CONMED Corporation
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07401095
- Sponsor's protocol ID
- ABBB
- Status last verified
- Jan 2026
- First submitted
- 3 Feb 2026
- Last updated
- 12 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Outcomes With and Without Use of a Novel Reinforced Bioinductive Implant in Arthroscopic Brostrom Repair: A Prospective Randomized Study
- ClinicalTrials.gov ID
- NCT07401095
- Acronym / sponsor ID
- ABBB
- Conditions
- ATFL, Lateral Ankle Instability, Anterior Talofibular Ligament, Anterior Talofibular Ligament Injury, Brostrom Procedure, Brostrom
- Keywords
- BioBrace, The BioBrace Implant, BioBrace Implant, ATFL, Lateral Ankle Instability, CONMED, Ankle, Ankle Injury
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Hancock OrthopedicsUniversity, hospital or other
- Collaborators
- CONMED Corporation
- Study start
- 8 Dec 2025 (actual)
- Primary completion
- Jun 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 10 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this investigation is to evaluate pre- and post-operative patient reported outcomes and functional scores after an all-arthroscopic Brostrom repair using either a suture anchor construct alone or suture anchors with the BioBrace Implant.
Detailed description
This is a single-center, prospective, randomized (1:1) interventional study investigating the use of the BioBrace® Implant in lateral ankle ligament repair procedures performed using an all-arthroscopic Broström technique. Eligible participants who meet study criteria will be enrolled and randomized into one of two study arms:
Control Group: Arthroscopic Broström repair using a suture-anchor construct only.
Treatment Group: Arthroscopic Broström repair using a suture-anchor construct augmented with the BioBrace® Implant.
Clinical evaluations will be conducted at baseline (preoperatively), and postoperatively at 1, 3, and 6 weeks, as well as at 3, 6, and 12 months using various patient-reported outcome measures to asses pain, function, activity and safety post surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 1:1 randomization
| Arm | Type | Receives |
|---|---|---|
| Control - Repair Only Group | Sham comparator | Other: Brostrom repair without augmentationProcedure: Standard of care Brostrom repair. |
| BioBrace Augment Group | Experimental | Device: Brostrom repair with augmentationBrostrom repair with BioBrace |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- At least 18 years of age at the time of surgery.
- Able to read, understand and sign the informed consent form.
- Willing to be available to attend each protocol required visit and complete the study required questionnaires.
- Scheduled to undergo primary, arthroscopic Brostrom repair.
Key exclusion criteria (8 listed)
- Previous Brostrom surgery.
- Concomitant procedures that would change the post operative course/recovery (i.e. total ankle replacement, OCD repair, foot/ankle osteotomies) as determined by the Investigator.
- Currently participating or plans to enroll in another clinical trial during this study that would affect the outcomes of this study as determined by the Investigator.
- History of non-compliance with medical treatment or clinical trial participation.
- The subject is physically or mentally compromised (e.g., currently being treated for a psychiatric disorder, senile dementia, Alzheimer's disease, etc.), to the extent that the Investigator judges the subject to be unable or unlikely to remain compliant with protocol required follow-up.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Brostrom repair with augmentationBrostrom repair with BioBrace | Device | BioBrace Augment Group |
| Brostrom repair without augmentationBrostrom repair without BioBrace | Other | Control - Repair Only Group |
Primary outcome
American Orthopedic Foot and Ankle Society score (AOFAS)
Time frame: Baseline, 1, 3, and 6 weeks & 3, 6, and 12 months
The AOFAS Score is a clinician-based assessment tool that evaluates pain, function, and alignment in patients with foot and ankle disorders. It provides a composite score ranging from 0 to 100, with higher scores indicating better function. The system includes region-specific scales (e.g., ankle-hindfoot, midfoot, hallux) and combines both patient-reported symptoms and objective clinician findings
Foot Function Index (FFI)
Time frame: Baseline, 1, 3, and 6 weeks & 3, 6, and 12 months
The Foot Function Index (FFI) is a patient-reported questionnaire used to assess how foot conditions affect pain, disability, and activity limitation. It includes 23 items rated on a 0-10 scale, with higher scores indicating greater impairment in foot function.
Visual Analog Scale (VAS)
Time frame: Baseline, 1, 3, and 6 weeks & 3, 6, and 12 months
The Visual Analog Scale (VAS) is a tool used to measure the intensity of pain or other subjective symptoms. It consists of a 10-cm line labeled "no pain" at one end and "worst imaginable pain" at the other; patients mark their pain level on the line, which is then measured to provide a numerical score from 0 to 100.
Karlsson-Peterson score
Time frame: Baseline, 1, 3, and 6 weeks & 3, 6, and 12 months
The Karlsson-Peterson Score is a functional ankle assessment tool that evaluates symptoms such as pain, swelling, instability, stiffness, stair-climbing ability, running ability, work/activity level, and need for support, producing a total score up to 100, with higher scores indicating better ankle function.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2026.
- Individual participant dataSharing planned: Undecided
Related trials for ATFL
Not yet recruiting
Collagen Scaffold Bioaugmentation for ATFL Repair in Chronic Ankle Instability
Chronic Ankle Instability, Ankle Sprain
Recruiting
Brostrom Chronic Lateral Ankle Instability Repairs Augmented With BioBrace®
Lateral Ankle Instability, Chronic Lateral Ankle Instability
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Brostrom repair with augmentation and Brostrom repair without augmentation in people with ATFL and Lateral Ankle Instability, run by Hancock Orthopedics at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jay Badell, DPM, MS, FACFAS (317-477-6683, JBadell@hancockhealth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
American Orthopedic Foot and Ankle Society score (AOFAS) (time frame: Baseline, 1, 3, and 6 weeks & 3, 6, and 12 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2026.