Status:
TERMINATED
Embody Insertional Achilles Tendinopathy
Lead Sponsor:
Zimmer Biomet
Collaborating Sponsors:
Embody Inc.
Conditions:
Insertional Achilles Tendinopathy
Eligibility:
All Genders
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 Im...
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 describ...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
August 2 2022
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
August 1 2024
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT05998785
Start Date
August 2 2022
End Date
August 1 2024
Last Update
December 20 2024
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
Weil Foot and Ankle Institute
Libertyville, Illinois, United States, 60048
2
Utica Park Clinic
Tulsa, Oklahoma, United States, 74104