Evaluation of the Rotation Medical Bioinductive Implant for Insertional Achilles Tendinopathy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 4
- 主要终点
- MRI Measurements of Tendon Thickening (Combined Tendon and New Tissue)
研究概览
简要总结
To evaluate bioinduction of new tissue and tendon healing after implantation of the Rotation Medical Bioinductive Implant used as adjunct to surgical repair in the treatment of insertional Achilles tendonitis.
详细描述
This is a prospective, non-randomized, single-arm study conducted under a common protocol designed to evaluate long-term outcomes following open treatment and implantation of the Rotation Medical Bioinductive Implant to treat insertional Achilles tendinopathy.
Up to 20 subjects will be enrolled and treated with the Rotation Medical Bioinductive Implant.
Enrollment is anticipated to take up to 12 months and all subjects will be followed for two years after surgery. Therefore, the overall study duration is estimated to be 36 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •At least 21 years of age
- •Insertional Achilles tendonitis requiring surgery that has failed conservative management, which consist of:
- •A. Shoe modification B. Nonsteroidal anti-inflammatory drugs C. Physical Therapy with/without modalities
- •Chronic Achilles tendon pain lasting longer than 3 months
- •MRI or X-ray of the ankle within 60 days prior to the study procedure
- •Willing to comply with the prescribed post-operative rehabilitation program
- •Willing to be available for each protocol-required follow-up examination
- •Able to understand the informed consent process, including regulatory requirements such as HIPAA authorization, and document informed consent prior to completion of any study-related procedures
- •Ability to read, understand, and complete subject-reported outcomes in English
排除标准
- •Achilles tendon rupture
- •Previous Achilles tendon surgery on the index ankle
- •Genetic collagen disease
- •History of auto-immune or immunodeficiency disorders
- •History of chronic inflammatory disorders
- •Oral steroid use in last 2 months or injectable steroid use in last 4 weeks
- •History of heavy smoking (> 1 pack per day) within last 6 months
- •Hypersensitivity to bovine-derived materials
- •Hypersensitivity to Polylactic Acid (PLA) and Polyetheretherketone (PEEK) materials
- •Metal implants, fillings, shrapnel, and/or screws
- •Females of child-bearing potential who are pregnant or plan to become pregnant during the course of the study
- •Currently involved in any injury litigation or worker's compensation claims relating to the index ankle
- •Enrolled, or plans to enroll, in another clinical trial during this study that would affect the outcomes of this study
- •History of non-compliance with medical treatment, physical therapy/rehabilitation, or clinical study participation
- •History of cognitive or mental health status that interferes with study participation
结局指标
主要结局
MRI Measurements of Tendon Thickening (Combined Tendon and New Tissue)
时间窗: 3, 12, and 24 months
Combined measurement of tendon and new tissue thickness in millimeters will be made from sagittal magnetic resonance imaging (MRI) at the insertion (approximately 5-10mm proximal to the bone anchor).
New Tissue Thickness
时间窗: 3, 12, and 24 months
Measurement of new tissue thickness in millimeters will be made from sagittal magnetic resonance imaging (MRI) at the level of the bone anchor. These measurements were made distal to the attachment of the Achilles tendon, which do not include the thickness of the repaired tendon; therefore, these thicknesses represent the thickness of the newly induced tissue only.
Tear Rate
时间窗: following surgery to end of treatment at 24 months
Tear rate in the deep portion of the repair at the calcaneus following Achilles surgery will be assessed at each follow-up visit using magnetic resonance imaging (MRI).
次要结局
- Participant Satisfaction(12 months)
- Device Implant Time(Intraoperatively, up to 9 minutes)
- CAM Boot Time(1 week following surgery to 12 months)
- Rehabilitation Visits(4 weeks following surgery to end of treatment at 24 months)
- Time to Recovery(following surgery to end of treatment at 24 months)
- Number of Participants With Procedure Technical Success(Intraoperatively, up to 9 minutes)