MedTrace Logo

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

NCT02719288 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 64

Last updated 2020-03-31

No results posted yet for this study

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

  • Peroneal and Achilles Tendon Tears

Interventions

OTHER

CLARIX® CORD 1K graft

Sponsors & Collaborators

  • Amniox Medical, Inc.

    lead INDUSTRY

Principal Investigators

  • Scheffer Tseng, MD, PhD · BioTissue Holdings, Inc

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-02-15
Primary Completion
2018-12-18
Completion
2018-12-18

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02719288 on ClinicalTrials.gov