Back to resultsNeoPatch Used as Adjunct in Foot and Ankle Tendon Surgery
Primary Purpose
Tendinopathy, Tendon Tear, Tendon Injuries
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
NeoPatch
Sponsored by
About this trial
This is an interventional prevention trial for Tendinopathy
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.
Sites / Locations
- Advanced Foot and Ankle Surgeons
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Treatment
Arm Description
NeoPatch
Outcomes
Primary Outcome Measures
Quantitative ultrasound assessment of post-operative adhesions
Average physical measurement of target tendon adhesions in mm, by ultrasound assessment.
Quantitative ultrasound assessment of post-operative adhesions
Average physical measurement of target tendon adhesions in mm, by ultrasound assessment.
Quantitative ultrasound assessment of post-operative adhesions
Average physical measurement of target tendon adhesions in mm, by ultrasound assessment.
Quantitative ultrasound assessment of post-operative adhesions
Average physical measurement of target tendon adhesions in mm, by ultrasound assessment.
Change in quantitative ultrasound assessment of post-operative adhesions
Average percent change in physical measurement of target tendon adhesions, by ultrasound assessment.
Qualitative ultrasound assessment of post-operative adhesions
Categorical summary of adhesion severity, reported by ultrasound assessment, described as mild, moderate, or severe.
Qualitative ultrasound assessment of post-operative adhesions
Categorical summary of adhesion severity, reported by ultrasound assessment, described as mild, moderate, or severe.
Qualitative ultrasound assessment of post-operative adhesions
Categorical summary of adhesion severity, reported by ultrasound assessment, described as mild, moderate, or severe.
Qualitative ultrasound assessment of post-operative adhesions
Categorical summary of adhesion severity, reported by ultrasound assessment, described as mild, moderate, or severe.
Secondary Outcome Measures
VAS Average Pain Score
Average self-reported pain experienced on average
VAS Current Pain Score
Average self-reported pain experienced at time of assessment (current)
Change in VAS Average Pain Score
Average change in self-reported average pain from baseline (screening) to last follow-up visit.
Change in VAS Current Pain Score
Average change in self-reported current pain from baseline (screening) to last follow-up visit.
AOFAS Foot and Ankle Function Score
Average AOFAS score
AOFAS Foot and Ankle Function Score
Average AOFAS score
Change in AOFAS Foot and Ankle Function Score
Average AOFAS score change between baseline (Screening) and Visit 7
Change in AOFAS Foot and Ankle Function Score
Average AOFAS score change between baseline (Screening) and Visit 8
Use of Analgesics
Percentage of patients on analgesics, including NSAIDs and narcotics, for the treatment of their target tendon pain.
Change in the Use of Analgesics
Percent change of patients on analgesics, including NSAIDs and narcotics, for the treatment of their target tendon pain.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03307499
Brief Title
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
2. Study Status
Record Verification Date
May 2019
Overall Recruitment Status
Completed
Study Start Date
September 21, 2017 (Actual)
Primary Completion Date
December 31, 2018 (Actual)
Study Completion Date
May 15, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
CryoLife, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tendinopathy, Tendon Tear, Tendon Injuries, Foot Ankle Injuries
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
7 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treatment
Arm Type
Experimental
Arm Description
NeoPatch
Intervention Type
Other
Intervention Name(s)
NeoPatch
Intervention Description
NeoPatch as an adjunct to foot and ankle tendon revision/repair surgery
Primary Outcome Measure Information:
Title
Quantitative ultrasound assessment of post-operative adhesions
Description
Average physical measurement of target tendon adhesions in mm, by ultrasound assessment.
Time Frame
Up to 3 weeks, post-op
Title
Quantitative ultrasound assessment of post-operative adhesions
Description
Average physical measurement of target tendon adhesions in mm, by ultrasound assessment.
Time Frame
Up to 9 weeks, post-op
Title
Quantitative ultrasound assessment of post-operative adhesions
Description
Average physical measurement of target tendon adhesions in mm, by ultrasound assessment.
Time Frame
Up to 15 weeks, post-op
Title
Quantitative ultrasound assessment of post-operative adhesions
Description
Average physical measurement of target tendon adhesions in mm, by ultrasound assessment.
Time Frame
Up to 52 weeks, post-op
Title
Change in quantitative ultrasound assessment of post-operative adhesions
Description
Average percent change in physical measurement of target tendon adhesions, by ultrasound assessment.
Time Frame
Through study completion, an average of 1 year
Title
Qualitative ultrasound assessment of post-operative adhesions
Description
Categorical summary of adhesion severity, reported by ultrasound assessment, described as mild, moderate, or severe.
Time Frame
Up to 3 weeks, post-op
Title
Qualitative ultrasound assessment of post-operative adhesions
Description
Categorical summary of adhesion severity, reported by ultrasound assessment, described as mild, moderate, or severe.
Time Frame
Up to 9 weeks, post-op
Title
Qualitative ultrasound assessment of post-operative adhesions
Description
Categorical summary of adhesion severity, reported by ultrasound assessment, described as mild, moderate, or severe.
Time Frame
Up to 15 weeks, post-op
Title
Qualitative ultrasound assessment of post-operative adhesions
Description
Categorical summary of adhesion severity, reported by ultrasound assessment, described as mild, moderate, or severe.
Time Frame
Up to 52 weeks, post-op
Secondary Outcome Measure Information:
Title
VAS Average Pain Score
Description
Average self-reported pain experienced on average
Time Frame
Up to 1 year, post-op
Title
VAS Current Pain Score
Description
Average self-reported pain experienced at time of assessment (current)
Time Frame
Up to 1 year, post-op
Title
Change in VAS Average Pain Score
Description
Average change in self-reported average pain from baseline (screening) to last follow-up visit.
Time Frame
Through study completion, an average of 1 year
Title
Change in VAS Current Pain Score
Description
Average change in self-reported current pain from baseline (screening) to last follow-up visit.
Time Frame
Through study completion, an average of 1 year
Title
AOFAS Foot and Ankle Function Score
Description
Average AOFAS score
Time Frame
Up to 24 weeks, post-op
Title
AOFAS Foot and Ankle Function Score
Description
Average AOFAS score
Time Frame
Up to 52 weeks, post-op
Title
Change in AOFAS Foot and Ankle Function Score
Description
Average AOFAS score change between baseline (Screening) and Visit 7
Time Frame
Up to 24 weeks, post-op
Title
Change in AOFAS Foot and Ankle Function Score
Description
Average AOFAS score change between baseline (Screening) and Visit 8
Time Frame
Up to 52 weeks, post-op
Title
Use of Analgesics
Description
Percentage of patients on analgesics, including NSAIDs and narcotics, for the treatment of their target tendon pain.
Time Frame
Up to 52 weeks, post-op
Title
Change in the Use of Analgesics
Description
Percent change of patients on analgesics, including NSAIDs and narcotics, for the treatment of their target tendon pain.
Time Frame
Through study completion, an average of 1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Douglas Pacaccio, DPM
Organizational Affiliation
Advanced Foot and Ankle Surgeons
Official's Role
Principal Investigator
Facility Information:
Facility Name
Advanced Foot and Ankle Surgeons
City
Sycamore
State/Province
Illinois
ZIP/Postal Code
60178
Country
United States
12. IPD Sharing Statement
Learn more about this trial
NeoPatch Used as Adjunct in Foot and Ankle Tendon Surgery
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