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

This study has been terminated.
(Protocol halted due to less than anticipated recruitment.)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01708187
First Posted: October 16, 2012
Last Update Posted: November 3, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Greg Berlet, Orthopedic Foot and Ankle Center, Ohio
September 5, 2012
October 16, 2012
April 13, 2016
May 19, 2016
November 3, 2016
October 2012
November 2014   (Final data collection date for primary outcome measure)
Change in Ankle Pain, Inflammation, Function & Activity Limitation From Baseline to 12 Months [ Time Frame: Baseline,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

  • Change in patient questionnaires describing ankle pain, function & activity limiation [ Time Frame: one year ]
  • Change in thermal imaging of the patients ankle [ Time Frame: 1 year ]
    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.
Complete list of historical versions of study NCT01708187 on ClinicalTrials.gov Archive Site
Not Provided
Number of patients with adverse events [ Time Frame: 1 year ]
Record information on any problems patients may have during the follow-up time.
Not Provided
Not Provided
 
The Role of C-HAM in the Surgical Repair of Peroneal Tendons: An Infrared Thermography Model
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.
Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Tendon Tears
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 Name: cryopreserved Human Amniotic Membrane (C-HAM) graft
  • Experimental: Clarix™1k graft
    Group 1 will have standard peroneal repair surgery with the addition of the Clarix™1k tissue.
    Intervention: Biological: Clarix™1k 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.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
2
November 2014
November 2014   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01708187
OH1-12-00396
No
Not Provided
Not Provided
Greg Berlet, Orthopedic Foot and Ankle Center, Ohio
Orthopedic Foot and Ankle Center, Ohio
Not Provided
Principal Investigator: Gregory C Berlet, MD Orthopedic Foot and Ankle Center
Orthopedic Foot and Ankle Center, Ohio
September 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP