Outcomes for VersaWrap in Achilles Tendon Repair
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 400
- 试验地点
- 3
- 主要终点
- Skin Excursion
研究概览
简要总结
The purpose of this study is to evaluate the efficacy on the use of VersaWrap® in surgery of the foot and ankle. VersaWrap is designed to allow tendon gliding and to protect tendon gliding postoperatively
详细描述
This is a prospective, multi-center, controlled case series evaluating the use of VersaWrap in surgeries of the foot and ankle. Patients identified by the Investigator in his practice as needing surgery for an Achilles primary or elective insertional repair and meeting all the inclusion and none of the exclusion. Patients will consent to participating in the study, prior to any study procedures.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients that require surgery for Achilles primary or elective insertional repair. Note: primary repair must be conducted within 6 weeks of injury. Additional repairs may be conducted during surgery, confirm with study Sponsor prior to enrollment. Insertional repairs due to trauma are not eligible.
- •Able to understand the requirements of the study, provide a written consent, and willing to comply with the study protocol
- •Age ≥18 years and <90 years at the time of surgery
排除标准
- •Investigator determines that the subject is unlikely to comply with the requirements of the study
- •Active systemic infection or infection at the location planned surgery
- •Uncontrolled diabetes
- •Prior Achilles surgery on either ankle
- •Active or suspected malignancy. If symptom free for 2 years, patients with prior malignancy may be included
- •Morbid obesity defined as a body mass index > 40
- •Pregnant or have plans to become pregnant in the next year
- •Currently a prisoner
- •Autoimmune disorders that impact the musculoskeletal system (e.g., lupus, rheumatoid arthritis; ankylosing spondylitis)
- •Medications that could interfere with fusion or other bone/soft tissue healing (e.g., anticipated continued use of systemic steroid medication postoperatively)
结局指标
主要结局
Skin Excursion
时间窗: 12 months post surgery
Skin excursion will be measured by examining the movement that is regularly repeated in a portion of involved skin in comparison to movement of the skin in the peroneal region of the contralateral foot. A ruler will be utilized to measure the up and down movement at the center of the skin excision, to determine the exact amount of excursion of the center of the wound.
Range of Motion (ROM)
时间窗: 12 months post surgery
Standing dorsi- and plantarflexion of the affected and contralateral ankle will be measured using a handheld goniometer, referencing the long axis of the fibula and fifth metatarsal shaft. Both passive and active range of motion will be captured. The greater the ROM the better the outcome.
次要结局
未报告次要终点