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Clinical Trial Summary

To evaluate the use of ReNu™ allograft for the augmentation of marrow stimulation for osteochondral lesions


Clinical Trial Description

This is a prospective, non-randomized, longitudinal study of up to 8 evaluable participants recruited from two separate practices. Male and non-pregnant female patients between the ages of 18 and 55 years of age will be screened for study recruitment. Female patients must be actively practicing a contraception method, abstinence, be surgically sterilized, or be postmenopausal. Participants will receive ReNu™ as an adjunct to their standard of care marrow stimulation for the treatment of osteochondral defects.

At each follow-up visit, concomitant medications and adverse events shall be collected from each subject, and each subject shall complete the following questionnaires:

IKDC Health Assessment (Includes Short Form-36) Tegner KOOS Knee Survey VAS Pain Scale SANE score

The subjects will be assessed at Baseline using these scales an again at all subsequent study follow-up visits. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03036878
Study type Interventional
Source NuTech Medical, Inc
Contact
Status Terminated
Phase N/A
Start date February 7, 2017
Completion date December 6, 2019

See also
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