NeoPatch Used as Adjunct in Foot and Ankle Tendon Surgery

NCT ID: NCT03307499

Last Updated: 2019-05-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 7 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-09-21
• Study Completion Date: 2019-05-15

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. NeoPatch is a tissue covering derived from terminally sterilized, dehydrated human placental membrane tissue comprised of both amnion and chorion. Candidates for this study are patients presenting with chronic tendon pain that are being evaluated for primary tendon revision surgery following failure of standard of care or immediate need for surgery, as determined by the investigator. Consented patients will receive NeoPatch as an adjunct to their foot or ankle tendon revision; NeoPatch will be wrapped around the tendon immediately prior to closure. The study will be divided into two phases: Screening and Follow-up. The study will include prospective patient evaluations at scheduled clinic visits and ultrasound appointments for a maximum of 12 visits over 12 months. Patient history, medications, self-reported pain, tendon status, and adverse events will be collected on all patients consented and enrolled into the study.

Conditions

Tendinopathy; Tendon Tear; Tendon Injuries; Foot Ankle Injuries

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Treatment

NeoPatch

Group Type: EXPERIMENTAL

NeoPatch

Intervention Type: OTHER

NeoPatch as an adjunct to foot and ankle tendon revision/repair surgery

Interventions

NeoPatch

NeoPatch as an adjunct to foot and ankle tendon revision/repair surgery

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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 Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

CryoLife, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Douglas Pacaccio, DPM

Role: PRINCIPAL_INVESTIGATOR

Advanced Foot and Ankle Surgeons

Locations

Advanced Foot and Ankle Surgeons

Sycamore, Illinois, United States

Countries

United States

Other Identifiers

HPM1701.000-M

Identifier Type: -

Identifier Source: org_study_id