Embody Insertional Achilles Tendinopathy

NCT05998785 | Terminated FDA Device

• 1 other identifier: EMBODY-002
• Study Type: observational
• Target: 8
• Locations: 1 country
• Sites: 2

Brief 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

Outcome Measures

Primary Outcomes (1)

• Pain/VAS

  Visual Analog Scale (VAS) survey

  12 months post-surgery

Secondary Outcomes (6)

• Safety/Adverse Events

  Surgery, 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

• Return to Normal Activity

  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

• SF-12

  Baseline, 1 week, 2 weeks, 4 weeks, 6 weeks, 10 weeks, 3 months, 6 moths and 12 months post-op

Interventions

TAPESTRY Biointegrative Implant DEVICE

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.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Enrolled subjects will include adults with insertional Achilles tendonitis requiring surgery, who meet the study eligibility criteria.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Zimmer Biomet: lead
• Embody Inc.: collaborator

Study Sites (2)

Weil Foot and Ankle Institute

Libertyville, Illinois, 60048, United States

Location

Utica Park Clinic

Tulsa, Oklahoma, 74104, United States

Location

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 11, 2023
• First Posted: August 21, 2023
• Study Start: August 2, 2022
• Primary Completion: August 1, 2024
• Study Completion: August 1, 2024
• Last Updated: December 20, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)