NeoPatch Used as Adjunct in Foot and Ankle Tendon Surgery

NCT03307499 | Completed

• 1 other identifier: HPM1701.000-M
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

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.

Conditions

Tendinopathy; Tendon Tear; Tendon Injuries; Foot Ankle Injuries

Outcome Measures

Primary Outcomes (9)

• 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

  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

Secondary Outcomes (10)

• VAS Average Pain Score

  Up to 1 year, post-op

• VAS Current Pain Score

  Up to 1 year, post-op

• Change in VAS Average Pain Score

  Through study completion, an average of 1 year

• Change in VAS Current Pain Score

  Through study completion, an average of 1 year

• AOFAS Foot and Ankle Function Score

  Up to 24 weeks, post-op

Study Arms (1)

Treatment

EXPERIMENTAL

NeoPatch

Other: NeoPatch

Interventions

NeoPatch OTHER

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

Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• CryoLife, Inc.: lead

Study Sites (1)

Advanced Foot and Ankle Surgeons

Sycamore, Illinois, 60178, United States

Location

MeSH Terms

Conditions

Tendinopathy; Tendon Injuries

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Wounds and Injuries

Study Officials

• Douglas Pacaccio, DPM

  Advanced Foot and Ankle Surgeons

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 12, 2017
• First Posted: October 11, 2017
• Study Start: September 21, 2017
• Primary Completion: December 31, 2018
• Study Completion: May 15, 2019
• Last Updated: May 24, 2019

Record last verified: 2019-05

Locations

US (1)