Clinical Trial: ReNu™ Marrow Stimulation Augmentation
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
Official Title: Evaluation of the ReNu™ Amniotic Suspension Allograft After Marrow Stimulation in the Treatment of Osteochondral Defects
Brief Summary: To evaluate the use of ReNu™ allograft for the augmentation of marrow stimulation for osteochondral lesions
Detailed Summary:
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.
Sponsor: NuTech Medical, Inc
Current Primary Outcome:
- Change in KOOS score from baseline [ Time Frame: 1 Year ]
- Change in Tegner score from baseline [ Time Frame: 1 Year ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Change in VAS score from baseline [ Time Frame: 6, 12 & 24 months ]
- Change in Tegner score from baseline [ Time Frame: 6 & 24 months ]
- Change in SANE score from baseline [ Time Frame: 6, 12 & 24 months ]
- Change in KOOS score from baseline [ Time Frame: 6 & 24 months ]
Original Secondary Outcome: Same as current
Information By: NuTech Medical, Inc
Dates:
Date Received: January 27, 2017
Date Started: January 12, 2017
Date Completion: June 2019
Last Updated: January 27, 2017
Last Verified: January 2017