Clinical trial NCT02719288: Peroneal and Achilles Tendon Repair Indications With CLARIX® CORD 1K
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Peroneal and Achilles Tendon Tears
Lead sponsor: Amniox Medical, Inc.
Sponsor class: INDUSTRY
First posted: 2016-03-25
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Change from baseline in patient questionnaire describing function limitation (American Orthopaedic Foot and Ankle Society ankle hindfoot score).
timeFrame: Baseline and 1 Year
Secondary outcomes:
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Banner Estrella Medical Center
state: Arizona
city: Sun City West
country: United States
facility: Banner Del Webb Medical Center
state: Arizona
city: Charlotte
country: United States
facility: OrthoCarolina Research Institute
state: North Carolina
city: Westerville
country: United States
facility: Orthopedic Foot and Ankle Center
state: Ohio
Study officials:
affiliation: BioTissue Holdings, Inc
name: Scheffer Tseng, MD, PhD
role: STUDY_CHAIR
References:
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citation: 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.
citation: 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.