Embody Insertional Achilles Tendinopathy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

8 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-08-02

Study Completion Date

2024-08-01

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.

Conditions

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Insertional Achilles Tendinopathy

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Interventions

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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.

Intervention Type DEVICE

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:

1. Shoe modification; or
2. Nonsteroidal anti-inflammatory drugs; or
3. 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.

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Locations

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Weil Foot and Ankle Institute

Libertyville, Illinois, United States

Site Status

Utica Park Clinic

Tulsa, Oklahoma, United States

Site Status

Countries

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United States

Other Identifiers

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EMBODY-002

Identifier Type: -

Identifier Source: org_study_id