A Multi-center, Prospective, Blinded, Randomized Study of Artelon FLEXBAND® for Patients Undergoing Soft Tissue Reconstruction of the Anterior Talofibular Ligament (ATFL) to Treat Lateral Ankle Instability
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 58
- 试验地点
- 16
- 主要终点
- Primary Efficacy Endpoint
研究概览
简要总结
The goal of this clinical trial is to analzye return to pre-injury activity level on study participants with lateral ankle instability undergoing a modified Bröstrom reconstruction procedure for repair of the ATFL. Study participants undergoing ATFL reconstructive procedure using the ARTELON FLEXBAND System as an augmentation device will be compared to study participants undergoing a standard modified Bröstrom procedure alone. Clinician reported safety and functional outcomes measures will be collected at baseline; and at 2-, 6-, 12-, 18 and 26-weeks and 1- and 2-years 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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects between and including the age of 18-75 at the time of surgery.
- •Subjects who were diagnosed with lateral ankle instability by physician clinical assessment.
- •Subjects who will undergo a modified Bröstrom procedure for an ATFL repair with or without FLEXBAND augmentation device (does not require an isolated repair).
- •Subjects that are able to understand, complete and sign the Consent Form.
排除标准
- •Significant secondary procedures done at the time of repair, including significant osteochondral lesions and/or significant microfracture of the talus or tibia that warrant modifying the typical lateral ligament repair post-op rehab protocol (minor microfractures and OCD lesions that do not warrant major bone debridement, synovectomies, and bone spur/osteophyte removals are allowed).
- •Any concomitant orthopedic procedure that will extend the post-op rehabilitation (e.g., casting/immobilization) beyond the routinely prescribed rehab protocol following an ATFL reconstructive procedure.
- •Subjects undergoing a Calcaneal osteotomy.
- •Subjects requiring major additional tendon surgery (i.e., peroneal tendon repair or tenodesis).
- •Neuropathy.
- •Subjects with diabetes, who, in the opinion of the investigator, are not sufficiently controlled.
- •BMI greater than 40 kg/m
- •Subjects with active Worker's Compensation Cases
- •Any subject with a history of infection of the ankle predating the ankle repair.
- •Subjects with a systemic ligament laxity disorder (i.e., Ehlers-Danlos Syndrome).
- •Any orthopedic issue outside of the ankle that the Investigator feels may impede functional endpoint outcome measures.
- •Subjects who have a medical history that would likely make the subject an unreliable research participant.
- •Subjects that are nursing or pregnant at the time of surgery.
- •Subjects with physician assessed untreated alcohol or substance abuse at the time of screening.
- •Subjects who are currently enrolled or participated in another investigational device, drug, or biological trial within 60 days of screening.
研究组 & 干预措施
FLEXBAND
This group will undergo a lateral ankle ligament repair using the modified Broström technique with Artelon FLEXBAND augmentation of the ATFL.
干预措施: Flexband (Device)
Control
This group will undergo a lateral ankle ligament repair using the modified Broström technique. This technique utilizes anchors to repair the ATFL, in some cases the CFL, lateral ankle capsule and extensor retinaculum. This will be done without Artelon FLEXBAND augmentation.
结局指标
主要结局
Primary Efficacy Endpoint
时间窗: From 2 weeks post-surgery to 26 weeks post-surgery.
The primary outcome measure will be subject reported assessment of time to pre-injury activity level.
Primary Safety Endpoint
时间窗: Time of surgery to 2 years post-surgery
The primary safety endpoints listed below will be recorded as adverse events and qualified as to whether they are procedure or product related. • Adverse Events related to the procedure including: * Delayed wound healing (4wks post-surgery) * Wound infection (superficial or deep) * Neuritis (persistent 6wks post-surgery) * Peri-implant osteolysis * Reoperations of the index ankle * Revisions of the ligament repair Additionally, complications necessitating a return to OR due to implant failure, foreign body reaction, or deep wound infection will be captured and characterized.
次要结局
- Physician Assessment of Healing(From 2 weeks post-surgery to 26 weeks post-surgery)
- Anterior Drawer Assessment(From 2 weeks post-surgery to 26 weeks post-surgery)
- Talar Tilt Assessment(From 2 weeks post-surgery to 26 weeks post-surgery)
- Pain Medication Usage(From 2 weeks post-surgery to 26 weeks post-surgery)
- FAAM(From 2 weeks post-surgery to 26 weeks post-surgery)
- FFI(From 2 weeks post-surgery to 26 weeks post-surgery)
- CAIT(From 2 weeks post-surgery to 26 weeks post-surgery)
- VAS Pain(From 2 weeks post-surgery to 26 weeks post-surgery)
- EQ-5D-5L(From 2 weeks post-surgery to 26 weeks post-surgery)
- Patient Satisfaction Scores(From 2 weeks post-surgery to 26 weeks post-surgery)
- FOTO(From 2 weeks post-surgery to 26 weeks post-surgery)