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Embody Insertional Achilles Tendinopathy

NCT05998785 · Status: TERMINATED · Type: OBSERVATIONAL · Enrollment: 8

Last updated 2024-12-20

No results posted yet for this study

Summary

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.

Conditions

  • Insertional Achilles Tendinopathy

Interventions

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.

Sponsors & Collaborators

  • Embody Inc.

    collaborator INDUSTRY

  • Zimmer Biomet

    lead INDUSTRY

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-08-02
Primary Completion
2024-08-01
Completion
2024-08-01
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05998785 on ClinicalTrials.gov