NCT05998785终止不适用
A Multi-Center, Prospective Case Series Evaluating Insertional Achilles Tendinopathy Repair Augmented with TAPESTRY® Biointegrative Implant
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 8
- 试验地点
- 2
- 主要终点
- Pain/VAS
研究概览
简要总结
The primary objective of this study is to evaluate the long-term effects on ankle/Achilles tendon pain after repair of insertional Achilles tendinopathy (IAT) augmented with TAPESTRY Biointegrative Implant.
详细描述
This study is a prospective case series of patients who have had insertional Achilles tendinopathy repair augmented with the Tapestry Biointegrative Implant. The primary aim of the study is to describe patient reported pain 12 months after surgical repair with Tapestry. The secondary aims are to assess the proportion of study subjects that experience treatment-related adverse events post-surgery, treatment related serious adverse events resulting in second surgical intervention, quality of life and other patient reported outcomes at all follow up timepoints post-surgery, and tissue thickness measured with MRI at 6 months post-surgery.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult, 21 years and older;
- •Insertional Achilles tendonitis requiring surgery that has failed at least 2 weeks of conservative management, which consist of:
- •Shoe modification; or
- •Nonsteroidal anti-inflammatory drugs; or
- •Physical Therapy with/without modalities.
- •Chronic Achilles tendon pain lasting longer than 3 months;
- •MRI of the ankle within 30 days prior to the study surgery;
- •Ability and willingness to comply with prescribed post-operative rehabilitation program;
- •Ability and willingness to comply with follow-up regimen;
- •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; and
- •Ability to read, understand, and complete subject-reported outcomes in English.
排除标准
- •History of Achilles tendon rupture;
- •Previous Achilles tendon surgery on the index ankle;
- •Genetic collagen disease, hypersensitivity, or objection to using bovine-derived materials;
- •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 poly(D,L-lactide) 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 studythat would affect the outcomes of this study; or
- •History of non-compliance with medical treatment, physical therapy/rehabilitation, or clinical study participation.
结局指标
主要结局
Pain/VAS
时间窗: 12 months post-surgery
Visual Analog Scale (VAS) survey
次要结局
- SF-12(Baseline, 1 week, 2 weeks, 4 weeks, 6 weeks, 10 weeks, 3 months, 6 moths and 12 months post-op)
- Patient Satisfaction(1 week, 2 weeks, 4 weeks, 6 weeks, 10 weeks, 3 months, 6 moths and 12 months post-op)
- Tissue Thickness(Baseline and 6 months post-op)
- Return to Normal Activity(1 week, 2 weeks, 4 weeks, 6 weeks, 10 weeks, 3 months, 6 moths and 12 months post-op)
- Safety/Adverse Events(Surgery, 1 week, 2 weeks, 4 weeks, 6 weeks, 10 weeks, 3 months, 6 moths and 12 months post-op)
- AOFAS(Baseline, 1 week, 2 weeks, 4 weeks, 6 weeks, 10 weeks, 3 months, 6 moths and 12 months post-op)
研究者
研究点 (2)
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