Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

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.
 
ClinicalTrials.gov Identifier: NCT01708187
Recruitment Status : Terminated (Protocol halted due to less than anticipated recruitment.)
First Posted : October 16, 2012
Results First Posted : May 19, 2016
Last Update Posted : November 3, 2016
Sponsor:
Information provided by (Responsible Party):
Greg Berlet, Orthopedic Foot and Ankle Center, Ohio

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment Phase
Tendon Tears Biological: Clarix™1k graft Not Applicable

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (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
Study Start Date : October 2012
Actual Primary Completion Date : November 2014
Actual Study Completion Date : November 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Foot Health Tears

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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 Name: 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.


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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



Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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 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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01708187


Locations
Layout table for location information
United States, Ohio
Orthopedic Foot and Ankle Center
Westerville, Ohio, United States, 43082
Sponsors and Collaborators
Orthopedic Foot and Ankle Center, Ohio
Investigators
Layout table for investigator information
Principal Investigator: Gregory C Berlet, MD Orthopedic Foot and Ankle Center
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Greg Berlet, MD, Orthopedic Foot and Ankle Center, Ohio
ClinicalTrials.gov Identifier: NCT01708187    
Other Study ID Numbers: OH1-12-00396
First Posted: October 16, 2012    Key Record Dates
Results First Posted: May 19, 2016
Last Update Posted: November 3, 2016
Last Verified: September 2016
Keywords provided by Greg Berlet, Orthopedic Foot and Ankle Center, Ohio:
Peroneal tendon