NeoPatch Used as Adjunct in Foot and Ankle Tendon Surgery

Post-market, Prospective Evaluation of Human Placental Membrane Tissue Used as an Adjunct for Foot and Ankle Tendon Surgery in Patients With Chronic Tendinopathy

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.

Study Overview

• Status: Completed
• Conditions: Tendon Injuries; Tendinopathy; Foot Ankle Injuries; Tendon Tear
• Intervention / Treatment: Other: NeoPatch

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 Type: Interventional
• Enrollment (Actual): 7
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Sycamore, Illinois, United States, 60178
      • Advanced Foot and Ankle Surgeons

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment; NeoPatch	Other: NeoPatch; NeoPatch as an adjunct to foot and ankle tendon revision/repair surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quantitative ultrasound assessment of post-operative adhesions	Average physical measurement of target tendon adhesions in mm, by ultrasound assessment.	Up to 3 weeks, post-op
Quantitative ultrasound assessment of post-operative adhesions	Average physical measurement of target tendon adhesions in mm, by ultrasound assessment.	Up to 9 weeks, post-op
Quantitative ultrasound assessment of post-operative adhesions	Average physical measurement of target tendon adhesions in mm, by ultrasound assessment.	Up to 15 weeks, post-op
Quantitative ultrasound assessment of post-operative adhesions	Average physical measurement of target tendon adhesions in mm, by ultrasound assessment.	Up to 52 weeks, post-op
Change in quantitative ultrasound assessment of post-operative adhesions	Average percent change in physical measurement of target tendon adhesions, by ultrasound assessment.	Through study completion, an average of 1 year
Qualitative ultrasound assessment of post-operative adhesions	Categorical summary of adhesion severity, reported by ultrasound assessment, described as mild, moderate, or severe.	Up to 3 weeks, post-op
Qualitative ultrasound assessment of post-operative adhesions	Categorical summary of adhesion severity, reported by ultrasound assessment, described as mild, moderate, or severe.	Up to 9 weeks, post-op
Qualitative ultrasound assessment of post-operative adhesions	Categorical summary of adhesion severity, reported by ultrasound assessment, described as mild, moderate, or severe.	Up to 15 weeks, post-op
Qualitative ultrasound assessment of post-operative adhesions	Categorical summary of adhesion severity, reported by ultrasound assessment, described as mild, moderate, or severe.	Up to 52 weeks, post-op

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
VAS Average Pain Score	Average self-reported pain experienced on average	Up to 1 year, post-op
VAS Current Pain Score	Average self-reported pain experienced at time of assessment (current)	Up to 1 year, post-op
Change in VAS Average Pain Score	Average change in self-reported average pain from baseline (screening) to last follow-up visit.	Through study completion, an average of 1 year
Change in VAS Current Pain Score	Average change in self-reported current pain from baseline (screening) to last follow-up visit.	Through study completion, an average of 1 year
AOFAS Foot and Ankle Function Score	Average AOFAS score	Up to 24 weeks, post-op
AOFAS Foot and Ankle Function Score	Average AOFAS score	Up to 52 weeks, post-op
Change in AOFAS Foot and Ankle Function Score	Average AOFAS score change between baseline (Screening) and Visit 7	Up to 24 weeks, post-op
Change in AOFAS Foot and Ankle Function Score	Average AOFAS score change between baseline (Screening) and Visit 8	Up to 52 weeks, post-op
Use of Analgesics	Percentage of patients on analgesics, including NSAIDs and narcotics, for the treatment of their target tendon pain.	Up to 52 weeks, post-op
Change in the Use of Analgesics	Percent change of patients on analgesics, including NSAIDs and narcotics, for the treatment of their target tendon pain.	Through study completion, an average of 1 year

Collaborators and Investigators

• Sponsor: CryoLife, Inc.
• Investigators: Principal Investigator: Douglas Pacaccio, DPM, Advanced Foot and Ankle Surgeons

Study record dates

Study Major Dates

• Study Start (Actual): September 21, 2017
• Primary Completion (Actual): December 31, 2018
• Study Completion (Actual): May 15, 2019

Study Registration Dates

• First Submitted: September 12, 2017
• First Submitted That Met QC Criteria: October 10, 2017
• First Posted (Actual): October 11, 2017

Study Record Updates

• Last Update Posted (Actual): May 24, 2019
• Last Update Submitted That Met QC Criteria: May 23, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Leg Injuries; Musculoskeletal Diseases; Muscular Diseases; Tendinopathy; Wounds and Injuries; Ankle Injuries; Tendon Injuries
• Other Study ID Numbers: HPM1701.000-M

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No