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New treatment option for ATFL
Official title BioBrace® in Arthroscopic Brostrom Lateral Ankle Ligament Repair
ClinicalTrials.gov ID: NCT07401095
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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.
You likely can't join if
- Previous Brostrom surgery.
- Concomitant procedures that would change the post operative course/recovery (i.e. total ankle replacement, OCD repair, foot/ankle osteotomies) as...
- Currently participating or plans to enroll in another clinical trial during this study that would affect the outcomes of this study as determined by...
- 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...
- Females of child-bearing potential who are either pregnant or breastfeeding or plan to become pregnant during the course of the study.
See the full eligibility criteria
- 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.
- 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...
- 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)
The study team makes the final eligibility decision.
Where it's taking place
- Greenfield, Indiana, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Greenfield, Indiana, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.