NCT05998785

Embody Insertional Achilles Tendinopathy

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

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 8 (actual)
• Sponsor: Zimmer Biomet · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Detailed description

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

• Insertional Achilles Tendinopathy

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2022-08-02
• Primary completion: 2024-08-01
• Completion: 2024-08-01
• First posted: 2023-08-21
• Last updated: 2024-12-20

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated device study