NeoPatch Used as Adjunct in Foot and Ankle Tendon Surgery

Tendinopathy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03307499
• Other study ID #: HPM1701.000-M
• Status: Completed
• Phase: N/A
• Start date: September 21, 2017
• Est. completion date: May 15, 2019

Study information

• Verified date: May 2019
• Source: CryoLife, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7
• Est. completion date: May 15, 2019
• Est. primary completion date: December 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Ankle Injuries
• Foot Ankle Injuries
• Tendinopathy
• Tendon Injuries
• Tendon Tear
• Wounds and Injuries

Intervention

Other:
• NeoPatch
NeoPatch as an adjunct to foot and ankle tendon revision/repair surgery

Locations

Country	Name	City	State
United States	Advanced Foot and Ankle Surgeons	Sycamore	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
CryoLife, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	VAS Average Pain Score	Average self-reported pain experienced on average	Up to 1 year, post-op
Secondary	VAS Current Pain Score	Average self-reported pain experienced at time of assessment (current)	Up to 1 year, post-op
Secondary	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
Secondary	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
Secondary	AOFAS Foot and Ankle Function Score	Average AOFAS score	Up to 24 weeks, post-op
Secondary	AOFAS Foot and Ankle Function Score	Average AOFAS score	Up to 52 weeks, post-op
Secondary	Change in AOFAS Foot and Ankle Function Score	Average AOFAS score change between baseline (Screening) and Visit 7	Up to 24 weeks, post-op
Secondary	Change in AOFAS Foot and Ankle Function Score	Average AOFAS score change between baseline (Screening) and Visit 8	Up to 52 weeks, post-op
Secondary	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
Secondary	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