Clinical trial NCT01708187: The Role of C-HAM in the Surgical Repair of Peroneal Tendons: An Infrared Thermography Model
Official title: The Role of Cryopreserved Human Amniotic Membrane in the Surgical Repair of Peroneal Tendons: An Infrared Thermography Model
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Tendon Tears
Keywords: Peroneal tendon
Lead sponsor: Orthopedic Foot and Ankle Center, Ohio
Sponsor class: OTHER
First posted: 2012-10-16
Enrollment: 2
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: Inclusion Criteria:

1. Patients requiring surgical repair of the peroneal tendon
2. Patients who voluntarily consent to research participation
3. Patients over the age of 18

Exclusion Criteria:

1. Patients who display a high surgical risk as determined by the investigative surgeon
2. Previous surgical repair of the peroneal tendon less than 2 years prior to surgery
3. Peroneus brevis tears in zone 3 or 4 that may hinder recovery in the investigator's opinion
4. Patients with allergy or history of drug reactions to Ciprofloxacin or Amphotericin B
5. Patients who are pregnant or breast feeding.
6. Patients who have had a clinically diagnosed autoimmune disease
7. 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
8. Patients with an active infection
9. Patients who have a medical history that would likely make the patient an unreliable research participant
10. Patients requiring surgical repair of the peroneus longus tendon

Primary outcomes:
measure: Change in Ankle Pain, Inflammation, Function & Activity Limitation From Baseline to 12 Months
timeFrame: Baseline,12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Westerville
country: United States
facility: Orthopedic Foot and Ankle Center
state: Ohio
Study officials:
affiliation: Orthopedic Foot and Ankle Center
name: Gregory C Berlet, MD
role: PRINCIPAL_INVESTIGATOR
References: