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

Zimmer Biomet2 sites in 1 country8 target enrollmentAugust 2, 2022

ConditionsInsertional Achilles Tendinopathy

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Insertional Achilles Tendinopathy
Sponsor: Zimmer Biomet
Enrollment: 8
Locations: 2
Primary Endpoint: Pain/VAS
Status: Terminated
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

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.

Registry

clinicaltrials.gov

Start Date

August 2, 2022

End Date

August 1, 2024

Last Updated

last year

Study Type

Observational

Sex

All

Investigators

Sponsor

Zimmer Biomet

Responsible Party

Sponsor

Eligibility Criteria

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:
•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

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;

Outcomes

Primary Outcomes

Pain/VAS

Time Frame: 12 months post-surgery

Visual Analog Scale (VAS) survey

Secondary Outcomes

SF-12(Baseline, 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)
Tissue Thickness(Baseline and 6 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)
Safety/Adverse Events(Surgery, 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)