Early Outcomes With and Without Use of a Novel Reinforced Bioinductive Implant in Arthroscopic Brostrom Repair: A Prospective Randomized Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- American Orthopedic Foot and Ankle Society score (AOFAS)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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)
研究组 & 干预措施
Control - Repair Only Group
Procedure: Standard of care Brostrom repair.
干预措施: Brostrom repair without augmentation (Other)
BioBrace Augment Group
Brostrom repair with BioBrace
干预措施: Brostrom repair with augmentation (Device)
结局指标
主要结局
American Orthopedic Foot and Ankle Society score (AOFAS)
时间窗: 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)
时间窗: 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)
时间窗: 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
时间窗: 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.
次要结局
未报告次要终点