Lateral Ankle Ligament Reconstruction With InternalBrace™ Augmentation: A Prospective Randomized Study
试验速览
- 阶段
- 不适用
- 入组人数
- 154
- 试验地点
- 3
- 主要终点
- Return to Work
研究概览
简要总结
Lateral ankle ligament stabilization procedures are well described in the orthopaedic literature. Although success rates are high, the incidence of recurrent instability is well documented. In addition, with standard rehabilitation protocols, the timeline to return to sport and functional activities may be prolonged. The InternalBrace Ligament Augmentation Repair is a safe and reproducible technique using FiberTape® and BioComposite SwiveLock® as an augmentation to a Brostrom procedure. The InternalBrace Ligament Augmentation repair consists of a FiberTape bridge between two Knotless Swivelock anchors providing a protective reinforcement and allows the surgeon to repair lateral or medial ankle instability and the pain associated with it. This type of repair can be utilized in acute and chronic ankle sprains.
详细描述
It is hypothesized that use of InternalBrace Ligament Augmentation in addition to standard anatomic modified Brostrum repair allows for earlier return to pre-injury level compared to a standard Brostrum procedure. It is also secondarily hypothesized that intermediate and long term incidence of recurrent instability will be lower with use of internal brace augmentation of standard modified Brostrum lateral ankle ligament reconstruction.
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
- •Subjects that consent to the study
- •Ages 18 and older
- •Subjects who are candidates for primary ankle instability reconstruction utilizing a standard Brostrum technique
- •Able to understand, complete and sign/date the Informed Consent Form (ICF)
排除标准
- •Subjects that are pregnant or planning to become pregnant within 58 weeks after surgery
- •Persons with a mental or cognitive disability deemed significant enough that they would not be capable of completing the outcome measures
- •Systemic laxity
- •Bony correction (i.e. calcaneal osteotomy)
- •Major additional tendon surgery such as tenodesis or repair of the peroneal tendon (synovectomy is allowable)
- •Major arthroscopic surgery such as treatment of chondral defects, including microfracture (arthroscopic synovectomy and arthroscopically treated osteophyte resection are allowable)
- •Revision surgery
- •Inadequate tissue for standard Brostrum reconstruction
- •Neuropathy
研究组 & 干预措施
Modified Brostrum procedure
Lateral ankle ligament stabilization procedure utilizing two 2.4mm BioComposite SutureTaks to repair the ATFL (anterior talo-fibular ligament), CFL (calcanealfibular ligament), lateral ankle capsule and extensor retinaculum.
干预措施: Modified Brostrum procedure (Device)
Modified Brostrum procedure with InternalBrace ligament augmentation
Lateral ankle ligament stabilization procedure utilizing two 2.4mm BioComposite SutureTaks to repair the ATFL, CFL, lateral ankle capsule and extensor retinaculum with InternalBrace fixation using a 4.75mm BioComposite SwiveLock.
干预措施: Modified Brostrum procedure with Internal Brace Augmentation (Device)
结局指标
主要结局
Return to Work
时间窗: Subject is called every 2 weeks between 6-26 weeks post-op timepoint and asked when they returned to pre-injury level.
Subject self-assessment of time of return to pre-injury level.
次要结局
- Tegner Activity Score(Data collected at the following time points: Pre-operative, 6 weeks, 12 weeks and 26 weeks.)
- Stress X-ray(Data will be collected at Pre-op and 1 year.)
- Veterans Rand (VR-12)(Data collected at the following time points: Pre-operative, 6 weeks, 12 weeks, 26 weeks, 1 year, 2 years, 3 years, 4 years, 5 years)
- Karlsson and Peterson Scoring System(Data collected at the following time points: Pre-operative, 6 weeks, 12 weeks, 26 weeks, 1 year, 2 years, 3 years, 4 years, 5 years)
- Range Of Motion(Data collected at the following time points: Pre-operative, 6 weeks, 12 weeks, 26 weeks and 1 year.)
- Return to Sports(Data collected at the following time points: 6 weeks, 12 weeks and 26 weeks)
- Visual Analog Scale (VAS)(Data collected at the following time points: Pre-operative, 3 weeks, 6 weeks, 12 weeks, 26 weeks, 1 year, 2 years, 3 years, 4 years, 5 years)
- Foot and Ankle Ability Measure (FAAM)(Data collected at the following time points: Pre-operative, 6 weeks, 12 weeks, 26 weeks, 1 year, 2 years, 3 years, 4 years, 5 years)