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

This study is not yet open for participant recruitment.
Verified October 2012 by Orthopedic Foot and Ankle Center, Ohio
Sponsor:
Information provided by (Responsible Party):
Greg Berlet, Orthopedic Foot and Ankle Center, Ohio
ClinicalTrials.gov Identifier:
NCT01708187
First received: September 5, 2012
Last updated: October 15, 2012
Last verified: October 2012
History of Changes
  Purpose

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 NEOX™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.


Condition Intervention
Tendon Tears
 Biological: NEOX™1k graft

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Role of Cryopreserved Human Amniotic Membrane in the Surgical Repair of Peroneal Tendons: An Infrared Thermography Model

Resource links provided by NLM:

MedlinePlus related topics: Foot Health
U.S. FDA Resources

Further study details as provided by Orthopedic Foot and Ankle Center, Ohio:

Primary Outcome Measures:
  • Change in patient questionnaires describing ankle pain, function & activity limiation [ Time Frame: one year ] [ Designated as safety issue: No ]
  • Change in thermal imaging of the patients ankle [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Take photographic pictures of your ankle with a special thermal imaging camera to measure the amount of inflammation at the surgical site, as well as the opposite ankle for comparison. This camera is non-invasive, non-radiating and painless.


Secondary Outcome Measures:
  • Number of patients with adverse events [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Record information on any problems patients may have during the follow-up time.


Estimated Enrollment: 40
Study Start Date: October 2012
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: NEOX™1k tissue
Group 1 will have standard peroneal repair surgery with the addition of the NEOX™1k tissue.
 Biological: NEOX™1k graft

Group 1 will have standard peroneal repair surgery with the addition of the NEOX™1k tissue.

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

Other Name: cryopreserved Human Amniotic Membrane (C-HAM) graft
No Intervention: Control arm without NEOX™1k tissue
Group 2 will have standard peroneal repair surgery without the use of the NEOX™1k tissue.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  3. Patients with allergy or history of drug reactions to Ciprofloxacin or Amphotericin B
  4. Patients who are pregnant or breast feeding.
  5. Patients who have had a clinically diagnosed autoimmune disease
  6. Patients who are unwilling to restrict pre and postoperative anti-inflammatories
  7. Patients with an active infection
  8. Patients who have a medical history that would likely make the patient an unreliable research participant
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01708187

Contacts
Contact: Emily Stansbury 614-895-8747 ofacresearch@orthofootankle.com

Locations
United States, Ohio
Orthopedic Foot and Ankle Center Not yet recruiting
Westerville, Ohio, United States, 43082
Contact: Emily Stansbury, BA     614-895-8747     ofacresearch@orthofootankle.com    
Sponsors and Collaborators
Orthopedic Foot and Ankle Center, Ohio
  More Information

No publications provided

Responsible Party: Greg Berlet, MD, Orthopedic Foot and Ankle Center, Ohio
ClinicalTrials.gov Identifier: NCT01708187     History of Changes
Other Study ID Numbers: OH1-12-00396
Study First Received: September 5, 2012
Last Updated: October 15, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Orthopedic Foot and Ankle Center, Ohio:
Peroneal tendon

ClinicalTrials.gov processed this record on May 16, 2013