Clinical trial NCT03307499: NeoPatch Used as Adjunct in Foot and Ankle Tendon Surgery
Official title: Post-market, Prospective Evaluation of Human Placental Membrane Tissue Used as an Adjunct for Foot and Ankle Tendon Surgery in Patients With Chronic Tendinopathy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tendinopathy
Tendon Tear
Tendon Injuries
Foot Ankle Injuries
Lead sponsor: CryoLife
Sponsor class: UNKNOWN
First posted: 2017-10-11
Enrollment: 7
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: Quantitative ultrasound assessment of post-operative adhesions
timeFrame: Up to 3 weeks, post-op
measure: Quantitative ultrasound assessment of post-operative adhesions
timeFrame: Up to 9 weeks, post-op
measure: Quantitative ultrasound assessment of post-operative adhesions
timeFrame: Up to 15 weeks, post-op
measure: Quantitative ultrasound assessment of post-operative adhesions
timeFrame: Up to 52 weeks, post-op
measure: Change in quantitative ultrasound assessment of post-operative adhesions
timeFrame: Through study completion, an average of 1 year
measure: Qualitative ultrasound assessment of post-operative adhesions
timeFrame: Up to 3 weeks, post-op
measure: Qualitative ultrasound assessment of post-operative adhesions
timeFrame: Up to 9 weeks, post-op
measure: Qualitative ultrasound assessment of post-operative adhesions
timeFrame: Up to 15 weeks, post-op
measure: Qualitative ultrasound assessment of post-operative adhesions
timeFrame: Up to 52 weeks, post-op
Secondary outcomes:
measure: VAS Average Pain Score
timeFrame: Up to 1 year, post-op
measure: VAS Current Pain Score
timeFrame: Up to 1 year, post-op
measure: Change in VAS Average Pain Score
timeFrame: Through study completion, an average of 1 year
measure: Change in VAS Current Pain Score
timeFrame: Through study completion, an average of 1 year
measure: AOFAS Foot and Ankle Function Score
timeFrame: Up to 24 weeks, post-op
measure: AOFAS Foot and Ankle Function Score
timeFrame: Up to 52 weeks, post-op
measure: Change in AOFAS Foot and Ankle Function Score
timeFrame: Up to 24 weeks, post-op
measure: Change in AOFAS Foot and Ankle Function Score
timeFrame: Up to 52 weeks, post-op
measure: Use of Analgesics
timeFrame: Up to 52 weeks, post-op
measure: Change in the Use of Analgesics
timeFrame: Through study completion, an average of 1 year
Other outcomes:
Locations:
city: Sycamore
country: United States
facility: Advanced Foot and Ankle Surgeons
state: Illinois
Study officials:
affiliation: Advanced Foot and Ankle Surgeons
name: Douglas Pacaccio, DPM
role: PRINCIPAL_INVESTIGATOR
References: