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

NCT ID: NCT01708187

Last Updated: 2016-11-03

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

2 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-10-31

Study Completion Date

2014-11-30

Brief Summary

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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.

Detailed Description

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Conditions

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Tendon Tears

Keywords

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Peroneal tendon

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Clarix™1k graft

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

Group Type EXPERIMENTAL

Clarix™1k graft

Intervention Type 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.

Control arm without Clarix™1k graft

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type BIOLOGICAL

Other Intervention Names

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cryopreserved Human Amniotic Membrane (C-HAM) graft

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Orthopedic Foot and Ankle Center, Ohio

OTHER

Sponsor Role lead

Responsible Party

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Greg Berlet

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Gregory C Berlet, MD

Role: PRINCIPAL_INVESTIGATOR

Orthopedic Foot and Ankle Center

Locations

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Orthopedic Foot and Ankle Center

Westerville, Ohio, United States

Site Status

Countries

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United States

Other Identifiers

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OH1-12-00396

Identifier Type: -

Identifier Source: org_study_id