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Trial record 5 of 5 for:    amniox

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

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ClinicalTrials.gov Identifier: NCT02719288
Recruitment Status : Completed
First Posted : March 25, 2016
Last Update Posted : March 31, 2020
Information provided by (Responsible Party):
Amniox Medical, Inc.

Brief Summary:

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.

Condition or disease Intervention/treatment Phase
Peroneal and Achilles Tendon Tears Other: CLARIX® CORD 1K graft Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 64 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : February 15, 2016
Actual Primary Completion Date : December 18, 2018
Actual Study Completion Date : December 18, 2018

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

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

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): NCT02719288

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United States, Arizona
Banner Estrella Medical Center
Phoenix, Arizona, United States, 85037
Banner Del Webb Medical Center
Sun City West, Arizona, United States, 85375
United States, North Carolina
OrthoCarolina Research Institute
Charlotte, North Carolina, United States, 28207
United States, Ohio
Orthopedic Foot and Ankle Center
Westerville, Ohio, United States, 43082
Sponsors and Collaborators
Amniox Medical, Inc.
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Study Chair: Scheffer Tseng, MD, PhD Tissue Tech Inc.
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Responsible Party: Amniox Medical, Inc.
ClinicalTrials.gov Identifier: NCT02719288    
Other Study ID Numbers: CR-2010
First Posted: March 25, 2016    Key Record Dates
Last Update Posted: March 31, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No