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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment | Experimental | NeoPatch |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NeoPatch | Other | NeoPatch as an adjunct to foot and ankle tendon revision/repair surgery |
|
| 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 |
| 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) |
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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:
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| Name | Affiliation | Role |
|---|---|---|
| Douglas Pacaccio, DPM | Advanced Foot and Ankle Surgeons | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Advanced Foot and Ankle Surgeons | Sycamore | Illinois | 60178 | United States |
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| ID | Term |
|---|---|
| D052256 | Tendinopathy |
| D013708 | Tendon Injuries |
| ID | Term |
|---|---|
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D014947 | Wounds and Injuries |
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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 |
| 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 |