Status:
COMPLETED
NeoPatch Used as Adjunct in Foot and Ankle Tendon Surgery
Lead Sponsor:
CryoLife, Inc.
Conditions:
Tendinopathy
Tendon Tear
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This study is a prospective, single center, postmarket study to evaluate the safety and effectiveness of NeoPatch used as a tissue cover in foot and ankle tendon revision and repair surgery.
Detailed Description
This study is a prospective, single center, postmarket study to evaluate the safety and effectiveness of NeoPatch used as a tissue cover for chronically injured tendons requiring surgical revision. Ne...
Eligibility Criteria
Inclusion
- Chronic tendinopathy requiring surgical revision in the opinion of the Investigator as defined in Appendix G.
- Intention to schedule surgical revision.
- ≥ 18 years.
- Free from clinical signs of infection at time of screening and at time of surgical intervention.
- Target tendon is one of the following: Achilles, Extensor Digitorum Longus, Extensor Hallucis Brevis, Extensor Hallucis Longus, Flexor Digitorum Longus, Flexor Hallucis Longus, Tibialis Anterior, Tibialis Posterior, Peroneus Longus, Peroneus Brevis, Peroneus Tertius.
- Able and willing to provide consent and comply with protocol.
Exclusion
- History of surgical intervention involving target tendon.
- Tendon injury is acute in nature.
- Current participation in another clinical study.
- Currently receiving radiation or chemotherapy.
- Diagnosis of autoimmune connective tissue disease requiring systemic immunomodulatory therapy; stable NSAID doses for mild rheumatoid arthritis permitted.
- Use of biomedical growth factor within previous 30 days.
- Pregnant or breastfeeding or planning on becoming pregnant or unwilling to use medically acceptable methods of birth control.
- Taking medications considered to be immune system modulators within previous 30 days.
- Patient taking specific Cox-2 inhibitors within previous 30 days.
- Currently being treated with an investigational device or drug (within 3 months prior to surgery).
- Allergy, intolerance or hypersensitivity to any components or packaging of the product.
Key Trial Info
Start Date :
September 21 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 15 2019
Estimated Enrollment :
7 Patients enrolled
Trial Details
Trial ID
NCT03307499
Start Date
September 21 2017
End Date
May 15 2019
Last Update
May 24 2019
Active Locations (1)
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1
Advanced Foot and Ankle Surgeons
Sycamore, Illinois, United States, 60178