Embody Insertional Achilles Tendinopathy (IAT)

December 17, 2024 updated by: Zimmer Biomet

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

8

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Libertyville, Illinois, United States, 60048
        • Weil Foot and Ankle Institute
    • Oklahoma
      • Tulsa, Oklahoma, United States, 74104
        • Utica Park Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety/Adverse Events
Time Frame: Surgery, 1 week, 2 weeks, 4 weeks, 6 weeks, 10 weeks, 3 months, 6 moths and 12 months post-op
  • 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
Time Frame: 1 week, 2 weeks, 4 weeks, 6 weeks, 10 weeks, 3 months, 6 moths and 12 months post-op
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
Time Frame: 1 week, 2 weeks, 4 weeks, 6 weeks, 10 weeks, 3 months, 6 moths and 12 months post-op
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
Time Frame: Baseline, 1 week, 2 weeks, 4 weeks, 6 weeks, 10 weeks, 3 months, 6 moths and 12 months post-op
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
Time Frame: Baseline, 1 week, 2 weeks, 4 weeks, 6 weeks, 10 weeks, 3 months, 6 moths and 12 months post-op
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
Time Frame: Baseline and 6 months post-op
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zimmer Biomet

Collaborators

Embody Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 2, 2022

Primary Completion (Actual)

August 1, 2024

Study Completion (Actual)

August 1, 2024

Study Registration Dates

First Submitted

August 11, 2023

First Submitted That Met QC Criteria

August 11, 2023

First Posted (Actual)

August 21, 2023

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

December 17, 2024

Last Verified

December 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EMBODY-002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe