Embody Insertional Achilles Tendinopathy

Zimmer Biomet8 enrolled

Overview

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.

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

Conditions

Insertional Achilles Tendinopathy

Interventions

TAPESTRY Biointegrative ImplantDEVICE

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

Sex: ALL

Medical Language ↔ Plain English

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.

Locations (2)

Weil Foot and Ankle Institute

Libertyville, Illinois, United States

Utica Park Clinic

Tulsa, Oklahoma, United States

Outcomes

Primary Outcomes

Pain/VAS

Visual Analog Scale (VAS) survey

Time frame: 12 months post-surgery

Secondary Outcomes

Safety/Adverse Events

* 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);

Time frame: Surgery, 1 week, 2 weeks, 4 weeks, 6 weeks, 10 weeks, 3 months, 6 moths and 12 months post-op

Patient Satisfaction

Patient Satisfaction Survey

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

Return to Normal Activity survey

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

AOFAS

American Orthopedic Foot and Ankle Society (AOFAS) Ankle-Hindfoot questionnaire

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

SF-12

12-item Short Form- Health Survey

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

Tissue Thickness

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.

Time frame: Baseline and 6 months post-op

Data from ClinicalTrials.gov

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