NeoPatch Used as Adjunct in Foot and Ankle Tendon Surgery

Completed · Not applicable

Conditions studied: Tendinopathy, Tendon Tear, Tendon Injuries, Foot Ankle Injuries

In brief

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.

Key facts

Study ID

NCT03307499

Run by

CryoLife, Inc.

People needed

7

Starts

2017-09-21

Expected to finish

2019-05-15

Last updated by the study team

2019-05-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Advanced Foot and Ankle Surgeons — Sycamore, Illinois, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.