Ignite Creation Date:
2026-03-26 @ 3:14 PM
Ignite Modification Date:
2026-03-31 @ 4:13 AM
Study NCT ID:
NCT07401095
Status:
RECRUITING
Last Update Posted:
2026-02-12
First Post:
2026-02-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
BioBrace® in Arthroscopic Brostrom Lateral Ankle Ligament Repair
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016512', 'term': 'Ankle Injuries'}], 'ancestors': [{'id': 'D007869', 'term': 'Leg Injuries'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '1:1 randomization'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-12-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-01', 'completionDateStruct': {'date': '2028-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-10', 'studyFirstSubmitDate': '2026-02-03', 'studyFirstSubmitQcDate': '2026-02-03', 'lastUpdatePostDateStruct': {'date': '2026-02-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'American Orthopedic Foot and Ankle Society score (AOFAS)', 'timeFrame': 'Baseline, 1, 3, and 6 weeks & 3, 6, and 12 months', 'description': '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'}, {'measure': 'Foot Function Index (FFI)', 'timeFrame': 'Baseline, 1, 3, and 6 weeks & 3, 6, and 12 months', 'description': '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.'}, {'measure': 'Visual Analog Scale (VAS)', 'timeFrame': 'Baseline, 1, 3, and 6 weeks & 3, 6, and 12 months', 'description': '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.'}, {'measure': 'Karlsson-Peterson score', 'timeFrame': 'Baseline, 1, 3, and 6 weeks & 3, 6, and 12 months', 'description': '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.'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['BioBrace', 'The BioBrace Implant', 'BioBrace Implant', 'ATFL', 'Lateral Ankle Instability', 'CONMED', 'Ankle', 'Ankle Injury'], 'conditions': ['ATFL', 'Lateral Ankle Instability', 'Anterior Talofibular Ligament', 'Anterior Talofibular Ligament Injury', 'Brostrom Procedure', 'Brostrom', 'Ankle']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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:\n\nControl Group: Arthroscopic Broström repair using a suture-anchor construct only.\n\nTreatment Group: Arthroscopic Broström repair using a suture-anchor construct augmented with the BioBrace® Implant.\n\nClinical 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. At least 18 years of age at the time of surgery.\n2. Able to read, understand and sign the informed consent form.\n3. Willing to be available to attend each protocol required visit and complete the study required questionnaires.\n4. Scheduled to undergo primary, arthroscopic Brostrom repair.\n\nExclusion Criteria:\n\n1. Previous Brostrom surgery.\n2. 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.\n3. 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.\n4. History of non-compliance with medical treatment or clinical trial participation.\n5. 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.\n6. Females of child-bearing potential who are either pregnant or breastfeeding or plan to become pregnant during the course of the study.\n7. Any comorbidity or condition that renders the patient a poor surgical candidate as determined by the Investigator.\n8. Hypersensitivity to any investigational device materials including collagen of animal origin (bovine type-I), poly-L-lactic acid (PLLA) or polyethylene glycol (PEG)"}, 'identificationModule': {'nctId': 'NCT07401095', 'briefTitle': 'BioBrace® in Arthroscopic Brostrom Lateral Ankle Ligament Repair', 'organization': {'class': 'OTHER', 'fullName': 'Hancock Orthopedics'}, 'officialTitle': 'Early Outcomes With and Without Use of a Novel Reinforced Bioinductive Implant in Arthroscopic Brostrom Repair: A Prospective Randomized Study', 'orgStudyIdInfo': {'id': 'ABBB'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'SHAM_COMPARATOR', 'label': 'Control - Repair Only Group', 'description': 'Procedure: Standard of care Brostrom repair.', 'interventionNames': ['Other: Brostrom repair without augmentation']}, {'type': 'EXPERIMENTAL', 'label': 'BioBrace Augment Group', 'description': 'Brostrom repair with BioBrace', 'interventionNames': ['Device: Brostrom repair with augmentation']}], 'interventions': [{'name': 'Brostrom repair with augmentation', 'type': 'DEVICE', 'description': 'Brostrom repair with BioBrace', 'armGroupLabels': ['BioBrace Augment Group']}, {'name': 'Brostrom repair without augmentation', 'type': 'OTHER', 'description': 'Brostrom repair without BioBrace', 'armGroupLabels': ['Control - Repair Only Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '46140', 'city': 'Greenfield', 'state': 'Indiana', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Jay Badell, DPM, MS, FACFAS', 'role': 'CONTACT', 'email': 'JBadell@hancockhealth.org', 'phone': '317-477-6683'}], 'facility': 'Hancock Orthopedics', 'geoPoint': {'lat': 39.78504, 'lon': -85.76942}}], 'centralContacts': [{'name': 'Jay Badell, DPM, MS, FACFAS', 'role': 'CONTACT', 'email': 'JBadell@hancockhealth.org', 'phone': '317-477-6683'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hancock Orthopedics', 'class': 'OTHER'}, 'collaborators': [{'name': 'CONMED Corporation', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}