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

Study Overview
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Brief Summary
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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.

Official Title
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The Role of Cryopreserved Human Amniotic Membrane in the Surgical Repair of Peroneal Tendons: An Infrared Thermography Model

Conditions
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Tendon Tears

Intervention / Treatment
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* Biological: Clarix™1k graft


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients requiring surgical repair of the peroneal tendon Patients who voluntarily consent to research participation Patients over the age of 18 Exclusion Criteria: Patients who display a high surgical risk as determined by the investigative surgeon Previous surgical repair of the peroneal tendon less than 2 years prior to surgery Peroneus brevis tears in zone 3 or 4 that may hinder recovery in the investigator's opinion Patients with allergy or history of drug reactions to Ciprofloxacin or Amphotericin B Patients who are pregnant or breast feeding. Patients who have had a clinically diagnosed autoimmune disease Patients who are unwilling to restrict pre and postoperative anti-inflammatories with the exception of ecotrin 325 mg QD for DVT prophylaxis during the postoperative immobilization period Patients with an active infection Patients who have a medical history that would likely make the patient an unreliable research participant Patients requiring surgical repair of the peroneus longus tendon

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Clarix™1k graft<br>Group 1 will have standard peroneal repair surgery with the addition of the Clarix™1k tissue. | Biological: Clarix™1k graft<br>* 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.<br>* Other names: cryopreserved Human Amniotic Membrane (C-HAM) graft;|
| No Intervention: Control arm without Clarix™1k graft<br>Group 2 will have standard peroneal repair surgery without the use of the Clarix™1k tissue. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Ankle Pain, Inflammation, Function & Activity Limitation From Baseline to 12 Months | Ankle pain measured via visual analog scale (VAS), function measured by American Orthopaedic Foot and Ankle Society (AOFAS) ankle hindfoot scale and Foot Function Index (FFI), activity limitation measured by AOFAS scale. Images taken via thermal camera to measure inflammation were not interpretable. VAS pain scale: 0-100, with a lower number representing a better score FFI scale: 0-100, with a lower number representing a better score AOFAS scale: 0-100, with a higher number representing a better score | Baseline,12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Peroneal tendon