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The Role of C-HAM in the Surgical Repair of Peroneal Tendons: An Infrared Thermography Model

NCT01708187 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 2

Last updated 2016-11-03

Study results available
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Summary

Peroneal tendon tears are a common etiology encountered by foot and ankle surgeons. Like all flexor tendon repairs adhesions are one of the more common challenges after surgery. Peroneal tendon gliding is key to their function as effective plantar flexors and evertors of the hindfoot. Scarring and adhesion correlate directly with the amount of inflammatory reaction at the wound site (Adzick 1994). Our goal is to have a surgical technique that allows for standard suture repair of the tendon yet allows for smooth gliding of the tendon with minimal adhesions. A prospective review on the surgical repair of the peroneal tendons utilizing Clarix™1k (Amniox Medical, Marietta, GA), cryopreserved Human Amniotic Membrane (C-HAM) graft will be performed. The investigators hypothesize that the use of cryopreserved Human Amniotic Membrane in conjunction with a peroneal tendon repair will decrease that amount of inflammation, overall recovery time of surgically repaired peroneal tendon tears, and adhesions.

Conditions

  • Tendon Tears

Interventions

BIOLOGICAL

Clarix™1k graft

Group 1 will have standard peroneal repair surgery with the addition of the Clarix™1k tissue. Group 2 will have standard peroneal repair surgery without the use of the Clarix™1k tissue.

Sponsors & Collaborators

  • Orthopedic Foot and Ankle Center, Ohio

    lead OTHER

Principal Investigators

  • Gregory C Berlet, MD · Orthopedic Foot and Ankle Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-10-31
Primary Completion
2014-11-30
Completion
2014-11-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01708187 on ClinicalTrials.gov