The Effect of Augmented Brostrom Repair Using Bioinductive Implant in Patients With Lateral Ankle Instability
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 75
- 试验地点
- 2
- 主要终点
- Pain VAS
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 open non-augmented Broström repair or open Broström repair augmented 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 the Broström technique. Eligible participants who meet study criteria will be enrolled and randomized into one of two study arms:
Control Group: Open standard Broström repair of the lateral ankle
Treatment Group: Open Broström repair of the lateral ankle using a suture-anchor construct augmented with the BioBrace® Implant.
Both groups will be immobilized for 2 weeks and then will undergo standard accelerated rehabilitation protocols (early weight-bearing and sport-specific training) unless they are not tolerated which will lead to using traditional standard protocols.
Clinical evaluations will be conducted at baseline (preoperatively), and postoperatively at 2 weeks, 2 months, 6 months, and 12 months using various patient-reported outcome measures to asses pain, function, satisfaction, activity and safety post surgery. Participants will also receive biweekly (every 2 weeks) electronic questionnaires assessing return to sport and return to daily/recreational activity. These biweekly assessments will continue until the participant reports full return to their preoperative level of activity or sport. Participants who do not reach preoperative activity/sport level will continue receiving biweekly questionnaires through the 1 year final visit.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-65 years
- •Chronic lateral ankle instability (>3 months) confirmed by clinical examination (positive anterior drawer test or talar tilt >10°) and imaging (stress X-ray or MRI).
- •No prior ankle surgery on the affected limb.
- •Willingness to follow postoperative visits and rehabilitation protocols and filling out the patient reported outcome measures (PROMs) forms.
排除标准
- •Significant secondary procedures done at the time of repair, including micro-fracture, or any other treatment of osteochondral lesions of the talus or tibia.
- •Concomitant deltoid ligament insufficiency.
- •Any worker's compensation case or any subject with a history of infection of the ankle predating the ankle repair. Current orthopedic issues, not related to the ankle, that prevented the patient from performing the functional tests.
- •Concomitant osteochondral lesions, significant degenerative changes, or severe varus/valgus deformity, neuromuscular disorders or non-adherence concerns.
- •Diagnosis of Ehlers-Danlos Syndrome or other connective tissue / hyperlaxity disorder.
- •Prior revision ankle ligament surgery on the affected limb (any revision Broström or lateral ligament reconstruction).
研究组 & 干预措施
Standard Brostrom Repair (SBR)
Standard-of-care Brostrom repair
干预措施: Standard Brostrom Repair (Procedure)
Augmented Brostrom Repair (ABR)
Brostrom repair augmented with BioBrace
干预措施: Brostrom repair with augmentation (Device)
结局指标
主要结局
Pain VAS
时间窗: From enrollment to the last follow-up at 12 months
The pain VAS (Visual Analog Scale) is a unidimensional measure of pain intensity, used to record patients' pain progression, or compare pain severity between patients. It consists of a line marked from 0 to 10, with 0 representing "no pain" at one end and 10 "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 10.
PROMIS Scale v2.0 - Pain Intensity 3a
时间窗: From enrollment to the last follow-up at 12 months.
The PROMIS Scale v2.0 - Pain Intensity 3a scale utilizes a 3-question questionnaire to assess patients' pain experiences over the previous 7 days. The items include the intensity of pain at its worst, the intensity of pain on average, and the level of pain right now. The items are scored on a scale from "Had no pain" to "Very severe".
NIH Toolbox Pain Interference CAT Ages 18 v3.0
时间窗: From enrollment to the last follow-up at 12 months.
The NIH Toolbox Pain Interference CAT Ages 18 v3.0 is a computerized adaptive test that evaluates how much pain has interfered with and affected a person's life and daily activities over the previous 7 days. The questions are generated dynamically based on previous answers. Results are reported as a T-score. A higher T-score indicates a greater degree of pain interference.
PROMIS Scale v1.2 - Global Mental 2a
时间窗: From enrollment to the last follow-up at 12 months.
The PROMIS Scale v1.2 - Global Mental 2a is a two-question questionnaire assessing participants' mental health, mood, ability to think, and satisfaction with social activities and relationships. The questions are scored from "Excellent" to "Poor".
PROMIS Scale v1.2 - Global Physical 2a
时间窗: From enrollment to the last follow-up at 12 months.
The PROMIS Scale v1.2 - Global Physical 2a is a two-question questionnaire designed to assess a participant's overall physical well-being. The participants are asked to rate their physical health on a scale from "Excellent" to "Poor" and their ability to carry out physical activities of daily living on a scale from "Completely" to "Not at all".
Foot and Ankle Outcome Score (FAOS)
时间窗: From enrollment to the last follow-up at 12 months.
The Foot and Ankle Outcome Score (FAOS) is a 42-item questionnaire with 5 subscales: symptoms (5 items), stiffness (2 items), pain (9 items), daily living (17 items), sports and recreational activities (5 items), and quality of life (4 items). Each question is graded on a 5-point scale (none, mild, moderate, severe, and extreme problems).
Foot and Ankle Ability Measure Scored
时间窗: From enrollment to last follow-up at 12 months.
The Foot and Ankle Ability Measure Scored tool has two sections. The first section asks participants to rate their difficulty completing activities of daily living on a scale from "No difficulty" to "Unable to do" over 21 different questions along with a rating their current level of function from 0 to 100, with 100 being their prior level of function. The second section asks participants to rate their difficulty in participating in sports activities on a scale from "No difficulty at all" to "Unable to do" over 7 different questions along with a rating their current level of function during sport activities from 0 to 100, with 100 being their prior level of function.
Clinical Assessment
时间窗: From enrollment to the last follow-up at 12 months.
Clinicians will assess participants during their follow-up appointments. The clinicians will measure an anterior drawer test, range of motion assessment, hindfoot alignment, wound/incision assessment, complications assessment, and a physical activity assessment.
次要结局
- Return to Activity(From baseline until participants report full return to activity or until last follow-up at 12 months.)
研究者
Soheil Ashkani Esfahani
Director, Foot & Ankle Research and Innovation Laboratory (FARIL); Assistant Professor, Department of Orthopaedic Surgery
Massachusetts General Hospital