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

NCT01708187 | Terminated Results

• 1 other identifier: OH1-12-00396
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

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.

Conditions

Tendon Tears

Keywords

Peroneal tendon

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Clarix™1k graft

EXPERIMENTAL

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

Biological: Clarix™1k graft

Control arm without Clarix™1k graft

NO INTERVENTION

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

Interventions

Clarix™1k graft BIOLOGICAL

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.

Also known as: cryopreserved Human Amniotic Membrane (C-HAM) graft

Clarix™1k graft

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients requiring surgical repair of the peroneal tendon
• Patients who voluntarily consent to research participation
• Patients over the age of 18

You may not qualify if:

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

Sponsors & Collaborators

• Orthopedic Foot and Ankle Center, Ohio: lead

Study Sites (1)

Orthopedic Foot and Ankle Center

Westerville, Ohio, 43082, United States

Location

MeSH Terms

Interventions

Transplantation

Intervention Hierarchy (Ancestors)

Surgical Procedures, Operative

Limitations and Caveats

Early termination leading to only one subject completing the trial.

Results Point of Contact

• Title: Gregory Berlet, MD
• Organization: Orthopedic Foot and Ankle Center

ofacresearch@orthofootankle.com

614-895-8747

Study Officials

• Gregory C Berlet, MD

  Orthopedic Foot and Ankle Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: September 5, 2012
• First Posted: October 16, 2012
• Study Start: October 1, 2012
• Primary Completion: November 1, 2014
• Study Completion: November 1, 2014
• Last Updated: November 3, 2016
• Results First Posted: May 19, 2016

Record last verified: 2016-09

Locations

US (1)