Peroneal and Achilles Tendon Repair Indications With CLARIX® CORD 1K
Completed · Not applicable
Conditions studied: Peroneal and Achilles Tendon Tears
In brief
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.
Key facts
- Study ID
- NCT02719288
- Run by
- Amniox Medical, Inc.
- People needed
- 64
- Starts
- 2016-02-15
- Expected to finish
- 2018-12-18
- Last updated by the study team
- 2020-03-31
Who can join
Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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
Where it is running
- Banner Estrella Medical Center — Phoenix, Arizona, United States
- Banner Del Webb Medical Center — Sun City West, Arizona, United States
- OrthoCarolina Research Institute — Charlotte, North Carolina, United States
- Orthopedic Foot and Ankle Center — Westerville, Ohio, United States
Full record on ClinicalTrials.gov
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