CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 64 enrolled
Drug / intervention
CLARIX® CORD 1K graftother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02719288
NCT02719288N/ACompleted

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

Amniox Medical, Inc.·interventional·Posted Mar 25, 2016·Updated Mar 31, 2020

In Brief

A clinical study evaluating CLARIX® CORD 1K graft for Peroneal and Achilles Tendon Tears. Completed, enrolled 64 participants across 4 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
20162017201820192020202120222023202420252026
First PostedMar 25, 2016
Enrollment StartFeb 15, 2016
Primary CompletionDec 18, 2018
TodayJul 2, 2026
Enrollment to primary: 2.8 yearsPosted 10.3 years ago

Interventions

CLARIX® CORD 1K graftother