Post-market, Prospective Evaluation of Human Placental Membrane Tissue Used as an Adjunct for Foot and Ankle Tendon Surgery in Patients With Chronic Tendinopathy
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- CryoLife, Inc.
- Enrollment
- 7
- Locations
- 2
- Primary Endpoint
- Qualitative ultrasound assessment of post-operative adhesions
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Treatment
NeoPatch
Intervention: NeoPatch (Other)
Outcomes
Primary Outcomes
Qualitative ultrasound assessment of post-operative adhesions
Time Frame: Up to 52 weeks, post-op
Categorical summary of adhesion severity, reported by ultrasound assessment, described as mild, moderate, or severe.
Quantitative ultrasound assessment of post-operative adhesions
Time Frame: Up to 52 weeks, post-op
Average physical measurement of target tendon adhesions in mm, by ultrasound assessment.
Change in quantitative ultrasound assessment of post-operative adhesions
Time Frame: Through study completion, an average of 1 year
Average percent change in physical measurement of target tendon adhesions, by ultrasound assessment.
Secondary Outcomes
- Change in VAS Average Pain Score(Through study completion, an average of 1 year)
- VAS Current Pain Score(Up to 1 year, post-op)
- Change in AOFAS Foot and Ankle Function Score(Up to 52 weeks, post-op)
- Use of Analgesics(Up to 52 weeks, post-op)
- Change in the Use of Analgesics(Through study completion, an average of 1 year)
- VAS Average Pain Score(Up to 1 year, post-op)
- Change in VAS Current Pain Score(Through study completion, an average of 1 year)
- AOFAS Foot and Ankle Function Score(Up to 52 weeks, post-op)