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

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

Study Description

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

Study Design

• 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

Arms and Interventions

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

Outcome Measures

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 ]

Eligibility Criteria

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

Criteria

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

Contacts and Locations

Locations

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.

Investigators

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

More Information

Publications:

Gelberman RH, Manske PR. Factors influencing flexor tendon adhesions. Hand Clin. 1985 Feb;1(1):35-42.

Adzick NS, Lorenz HP. Cells, matrix, growth factors, and the surgeon. The biology of scarless fetal wound repair. Ann Surg. 1994 Jul;220(1):10-8. doi: 10.1097/00000658-199407000-00003.

Jaibaji M. Advances in the biology of zone II flexor tendon healing and adhesion formation. Ann Plast Surg. 2000 Jul;45(1):83-92. doi: 10.1097/00000637-200045010-00017.

Liu J, Sheha H, Fu Y, Liang L, Tseng SC. Update on amniotic membrane transplantation. Expert Rev Ophthalmol. 2010 Oct;5(5):645-661. doi: 10.1586/eop.10.63.

Swift H. Amnion for leg ulcers. Lancet. 1980 Jun 21;1(8182):1366-7. doi: 10.1016/s0140-6736(80)91819-x. No abstract available.

Dua HS, Gomes JA, King AJ, Maharajan VS. The amniotic membrane in ophthalmology. Surv Ophthalmol. 2004 Jan-Feb;49(1):51-77. doi: 10.1016/j.survophthal.2003.10.004.

Bouchard CS, John T. Amniotic membrane transplantation in the management of severe ocular surface disease: indications and outcomes. Ocul Surf. 2004 Jul;2(3):201-11. doi: 10.1016/s1542-0124(12)70062-9.

• Responsible Party: Amniox Medical, Inc.
• ClinicalTrials.gov Identifier: NCT02719288
• Other Study ID Numbers: CR-2010
• First Posted: March 25, 2016
• Last Update Posted: March 31, 2020
• Last Verified: March 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No