Embody Insertional Achilles Tendinopathy

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Multi-Center, Prospective Case Series Evaluating Insertional Achilles Tendinopathy Repair Augmented With TAPESTRY® Biointegrative Implant

Conditions
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Insertional Achilles Tendinopathy

Intervention / Treatment
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* Device: TAPESTRY Biointegrative Implant


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: TAPESTRY Biointegrative Implant|Collagen-based implant composed of type I bovine collagen and poly(D,L-lactide). It is designed to function as a non-constricting, protective layer between the tendon and surrounding tissues. Preclinical studies of the Tapestry implant showed dense collagenous fibrous connective tissue ingrowth into and around the implant.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain/VAS | Visual Analog Scale (VAS) survey | 12 months post-surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety/Adverse Events | Procedure and/or treatment related adverse events; Procedure and/or treatment related Serious Adverse Events (SAE) Procedure and/or treatment related Serious Adverse Events (SAE) necessitating a second surgical intervention (SSI); | Surgery, 1 week, 2 weeks, 4 weeks, 6 weeks, 10 weeks, 3 months, 6 moths and 12 months post-op | 
| Patient Satisfaction | Patient Satisfaction Survey | 1 week, 2 weeks, 4 weeks, 6 weeks, 10 weeks, 3 months, 6 moths and 12 months post-op | 
| Return to Normal Activity | Return to Normal Activity survey | 1 week, 2 weeks, 4 weeks, 6 weeks, 10 weeks, 3 months, 6 moths and 12 months post-op | 
| AOFAS | American Orthopedic Foot and Ankle Society (AOFAS) Ankle-Hindfoot questionnaire | Baseline, 1 week, 2 weeks, 4 weeks, 6 weeks, 10 weeks, 3 months, 6 moths and 12 months post-op | 
| SF-12 | 12-item Short Form- Health Survey | Baseline, 1 week, 2 weeks, 4 weeks, 6 weeks, 10 weeks, 3 months, 6 moths and 12 months post-op | 
| Tissue Thickness | MRI tissue thickness of the Achilles tendon at baseline and 6 months post-surgery. Tissue thickness will be measured by trained personnel per the EMBODY-002 MRI procedure manual. | Baseline and 6 months post-op |