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

Stopped early · Not applicable

Conditions studied: Tendon Tears

In brief

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.

Key facts

Study ID

NCT01708187

Run by

Orthopedic Foot and Ankle Center, Ohio

People needed

2

Starts

2012-10-01

Expected to finish

2014-11-01

Last updated by the study team

2016-11-03

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients requiring surgical repair of the peroneal tendon
• Patients who voluntarily consent to research participation
• Patients over the age of 18

You may not qualify if…

• 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

Where it is running

• Orthopedic Foot and Ankle Center — Westerville, Ohio, United States

Full record on ClinicalTrials.gov

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