- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03307499
NeoPatch Used as Adjunct in Foot and Ankle Tendon Surgery
May 23, 2019 updated by: CryoLife, Inc.
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
Intervention / Treatment
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
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Illinois
-
Sycamore, Illinois, United States, 60178
- Advanced Foot and Ankle Surgeons
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 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
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Treatment
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
Time Frame: Up to 3 weeks, post-op
|
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
Time Frame: Up to 9 weeks, post-op
|
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
Time Frame: Up to 15 weeks, post-op
|
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
Time Frame: Up to 52 weeks, post-op
|
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
Time Frame: Through study completion, an average of 1 year
|
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
Time Frame: Up to 3 weeks, post-op
|
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
Time Frame: Up to 9 weeks, post-op
|
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
Time Frame: Up to 15 weeks, post-op
|
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
Time Frame: Up to 52 weeks, post-op
|
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
Time Frame: Up to 1 year, post-op
|
Average self-reported pain experienced on average
|
Up to 1 year, post-op
|
VAS Current Pain Score
Time Frame: Up to 1 year, post-op
|
Average self-reported pain experienced at time of assessment (current)
|
Up to 1 year, post-op
|
Change in VAS Average Pain Score
Time Frame: Through study completion, an average of 1 year
|
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
Time Frame: Through study completion, an average of 1 year
|
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
Time Frame: Up to 24 weeks, post-op
|
Average AOFAS score
|
Up to 24 weeks, post-op
|
AOFAS Foot and Ankle Function Score
Time Frame: Up to 52 weeks, post-op
|
Average AOFAS score
|
Up to 52 weeks, post-op
|
Change in AOFAS Foot and Ankle Function Score
Time Frame: Up to 24 weeks, post-op
|
Average AOFAS score change between baseline (Screening) and Visit 7
|
Up to 24 weeks, post-op
|
Change in AOFAS Foot and Ankle Function Score
Time Frame: Up to 52 weeks, post-op
|
Average AOFAS score change between baseline (Screening) and Visit 8
|
Up to 52 weeks, post-op
|
Use of Analgesics
Time Frame: Up to 52 weeks, post-op
|
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
Time Frame: Through study completion, an average of 1 year
|
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
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Douglas Pacaccio, DPM, Advanced Foot and Ankle Surgeons
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
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
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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