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

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

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.

Study Overview

• Status: Terminated
• Conditions: Tendon Tears
• Intervention / Treatment: Biological: Clarix™1k graft

• Study Type: Interventional
• Enrollment (Actual): 2
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Westerville, Ohio, United States, 43082
      • Orthopedic Foot and Ankle Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Orthopedic Foot and Ankle Center, Ohio
• Investigators: Principal Investigator: Gregory C Berlet, MD, Orthopedic Foot and Ankle Center

Study record dates

Study Major Dates

• Study Start: October 1, 2012
• Primary Completion (Actual): November 1, 2014
• Study Completion (Actual): November 1, 2014

Study Registration Dates

• First Submitted: September 5, 2012
• First Submitted That Met QC Criteria: October 15, 2012
• First Posted (Estimate): October 16, 2012

Study Record Updates

• Last Update Posted (Estimate): November 3, 2016
• Last Update Submitted That Met QC Criteria: September 29, 2016
• Last Verified: September 1, 2016

More Information

Terms related to this study

• Keywords: Peroneal tendon
• Other Study ID Numbers: OH1-12-00396