Trials / Completed
CompletedNCT02719288
Peroneal and Achilles Tendon Repair Indications With CLARIX® CORD 1K
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
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 64 (actual)
- Sponsor
- Amniox Medical, Inc. · Industry
- Sex
- All
- Age
- 18 Years – 80 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | CLARIX® CORD 1K graft |
Timeline
- Start date
- 2016-02-15
- Primary completion
- 2018-12-18
- Completion
- 2018-12-18
- First posted
- 2016-03-25
- Last updated
- 2020-03-31
Locations
4 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT02719288. Inclusion in this directory is not an endorsement.