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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Peroneal and Achilles Tendon Tears

Intervention / Treatment
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* Other: CLARIX® CORD 1K graft


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male and female patients 18 years to 80 years of age 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. Willing to follow the instructions and complete the visits required. Exclusion Criteria: Psychologically unstable Acute infections that, in the opinion of the investigator, may complicate healing Currently receiving chemotherapy Systemic inflammatory arthritis or Rheumatoid arthritis Uncontrolled diabetes as measured by A1C>12 Bleeding disorders Unable to provide informed consent 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 Immunocompromised patients Active malignancy other than non-melanoma skin cancer Untreated alcohol or substance abuse issues at the time of screening Pregnant women at the time of randomization Currently enrolled or participated in another investigational device, drug, or biological trial within 60 days of screening Allergy to amphotericin-B or Dulbecco's Modified Eagle Medium (DMEM). 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

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