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

Not Applicable

Completed

• Conditions: Peroneal and Achilles Tendon Tears
• Interventions: Other: CLARIX® CORD 1K graft

• Registration Number: NCT02719288
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-02-15
• Study First Submitted: 2016-03-17
• Study First Submitted QC: 2016-03-21
• Study First Posted: 2016-03-25
• Primary Completion: 2018-12-18
• Study Completion: 2018-12-18
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-27
• Last Update Posted: 2020-03-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 64

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CLARIX® CORD 1K	CLARIX® CORD 1K graft	Applied in addition to standard of care tendon repair surgery.

Primary Outcome Measures

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

Trial Locations

Locations (4)

Banner Del Webb Medical Center; 🇺🇸 Sun City West, Arizona, United States

Banner Estrella Medical Center; 🇺🇸 Phoenix, Arizona, United States

Orthopedic Foot and Ankle Center; 🇺🇸 Westerville, Ohio, United States

OrthoCarolina Research Institute; 🇺🇸 Charlotte, North Carolina, United States