Embody Insertional Achilles Tendinopathy

Insertional Achilles Tendinopathy Clinical Trial

— IAT  

Official title:

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

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT05998785
• Other study ID #: EMBODY-002
• Status: Suspended
• Start date: August 2, 2022
• Est. completion date: December 2024

Study information

• Verified date: December 2023
• Source: Zimmer Biomet
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 15
• Est. completion date: December 2024
• Est. primary completion date: August 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Insertional Achilles Tendinopathy
• Tendinopathy

Intervention

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.

Locations

Country	Name	City	State
United States	Weil Foot and Ankle Institute	Libertyville	Illinois
United States	Utica Park Clinic	Tulsa	Oklahoma

Sponsors (2)

Lead Sponsor	Collaborator
Zimmer Biomet	Embody Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain/VAS	Visual Analog Scale (VAS) survey	12 months post-surgery
Secondary	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);	Surgery, 1 week, 2 weeks, 4 weeks, 6 weeks, 10 weeks, 3 months, 6 moths and 12 months post-op
Secondary	Patient Satisfaction	Patient Satisfaction Survey	1 week, 2 weeks, 4 weeks, 6 weeks, 10 weeks, 3 months, 6 moths and 12 months post-op
Secondary	Return to Normal Activity	Return to Normal Activity survey	1 week, 2 weeks, 4 weeks, 6 weeks, 10 weeks, 3 months, 6 moths and 12 months post-op
Secondary	AOFAS	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
Secondary	SF-12	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
Secondary	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.	Baseline and 6 months post-op