Peroneal and Achilles Tendon Repair Indications With CLARIX® CORD 1K (PATRICC)

March 27, 2020 updated by: Amniox Medical, Inc.

A Multi-center, Open Label, Economic Outcome Study Comparing the Recovery of Patients Receiving CLARIX® CORD 1K as an add-on Treatment During Surgical Tendon Repair to Control Patients Receiving Standard of Care Procedures

Peroneal and Achilles tendon tears are common diseases that present challenges to surgeons due to tendon adhesion complications. Functional recovery is compromised by limiting post-operative range of motion, mobility, and can lead to considerable amount of post-operative pain for the patient.

Amniotic membrane tissue has demonstrated clinical success as an anti-inflammatory and anti-scarring agent and promoting wound healing towards regeneration.

Cryopreserved human amniotic membrane and umbilical cord (AM/UC) tissue in the form of CLARIX® CORD 1K has been used to treat over 5000 orthopedic patients. The investigators hypothesize that its use in peroneal and Achilles tendon surgical repair will enhance the overall functional recovery of the patient.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

64

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85037
        • Banner Estrella Medical Center
      • Sun City West, Arizona, United States, 85375
        • Banner Del Webb Medical Center
    • North Carolina
      • Charlotte, North Carolina, United States, 28207
        • OrthoCarolina Research Institute
    • Ohio
      • Westerville, Ohio, United States, 43082
        • Orthopedic Foot and Ankle Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Male and female patients 18 years to 80 years of age
  2. Confirmed tendon pathology via MRI, if clinically necessary, with planned surgical repair that have failed conservative management (PT) for a minimum of 2 months for chronic and partial thickness tears; acute full thickness tears or tendon rupture immediately eligible.
  3. Willing to follow the instructions and complete the visits required.

Exclusion Criteria:

  1. Psychologically unstable
  2. Acute infections that, in the opinion of the investigator, may complicate healing
  3. Currently receiving chemotherapy
  4. Systemic inflammatory arthritis or Rheumatoid arthritis
  5. Uncontrolled diabetes as measured by A1C>12
  6. Bleeding disorders
  7. Unable to provide informed consent
  8. Has received oral or parenteral corticosteroids or cytotoxic agents for seven consecutive days in the period of 30 days before surgery OR has received a local steroid injection within 7 days of surgery
  9. Immunocompromised patients
  10. Active malignancy other than non-melanoma skin cancer
  11. Untreated alcohol or substance abuse issues at the time of screening
  12. Pregnant women at the time of randomization
  13. Currently enrolled or participated in another investigational device, drug, or biological trial within 60 days of screening
  14. Allergy to amphotericin-B or Dulbecco's Modified Eagle Medium (DMEM).
  15. Will undergo significant concurrent procedures with the tendon procedures on the affected foot that, in the opinion of the Investigator, may complicate healing or alter the post-operative visit schedule

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: CLARIX® CORD 1K
Applied in addition to standard of care tendon repair surgery.
Other: CLARIX® CORD 1K graft
No Intervention: Standard of care tendon repair surgery only

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change from baseline in patient questionnaire describing function limitation (American Orthopaedic Foot and Ankle Society ankle hindfoot score).
Time Frame: Baseline and 1 Year
Baseline and 1 Year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Amniox Medical, Inc.

Investigators

  • Study Chair: Scheffer Tseng, MD, PhD, Tissue Tech Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 15, 2016

Primary Completion (Actual)

December 18, 2018

Study Completion (Actual)

December 18, 2018

Study Registration Dates

First Submitted

March 17, 2016

First Submitted That Met QC Criteria

March 21, 2016

First Posted (Estimate)

March 25, 2016

Study Record Updates

Last Update Posted (Actual)

March 31, 2020

Last Update Submitted That Met QC Criteria

March 27, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

  • CR-2010

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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