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.
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
Allocation
NA
Purpose
PREVENTION
Masking
NONE
Enrollment
7
NeoPatch as an adjunct to foot and ankle tendon revision/repair surgery
Advanced Foot and Ankle Surgeons
Sycamore, Illinois, United States
Quantitative ultrasound assessment of post-operative adhesions
Average physical measurement of target tendon adhesions in mm, by ultrasound assessment.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Up to 9 weeks, post-op
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Qualitative ultrasound assessment of post-operative adhesions
Categorical summary of adhesion severity, reported by ultrasound assessment, described as mild, moderate, or severe.
Time frame: 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.
Time frame: Up to 52 weeks, post-op
VAS Average Pain Score
Average self-reported pain experienced on average
Time frame: Up to 1 year, post-op
VAS Current Pain Score
Average self-reported pain experienced at time of assessment (current)
Time frame: 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.
Time frame: 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.
Time frame: Through study completion, an average of 1 year
AOFAS Foot and Ankle Function Score
Average AOFAS score
Time frame: Up to 24 weeks, post-op
AOFAS Foot and Ankle Function Score
Average AOFAS score
Time frame: Up to 52 weeks, post-op
Change in AOFAS Foot and Ankle Function Score
Average AOFAS score change between baseline (Screening) and Visit 7
Time frame: Up to 24 weeks, post-op
Change in AOFAS Foot and Ankle Function Score
Average AOFAS score change between baseline (Screening) and Visit 8
Time frame: 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.
Time frame: 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.
Time frame: Through study completion, an average of 1 year