ReNu™ Marrow Stimulation Augmentation
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03036878|
Recruitment Status : Terminated (Closed for lack of enrollment)
First Posted : January 30, 2017
Last Update Posted : January 18, 2020
|Condition or disease||Intervention/treatment||Phase|
|Osteochondral Defect||Other: ReNu||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Evaluation of the ReNu™ Amniotic Suspension Allograft After Marrow Stimulation in the Treatment of Osteochondral Defects|
|Actual Study Start Date :||February 7, 2017|
|Actual Primary Completion Date :||December 6, 2019|
|Actual Study Completion Date :||December 6, 2019|
Experimental: ReNu Injection
Injection of ReNu allograft into the joint capsule.
ReNu is an allograft tissue composed of particularized amniotic membrane and cell from the amniotic fluid.
- Change in KOOS score from baseline [ Time Frame: 1 Year ]
- Change in Tegner score from baseline [ Time Frame: 1 Year ]
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03036878
|United States, Indiana|
|Indianapolis, Indiana, United States, 46143|
|United States, New York|
|Hospital for Special Surgery|
|New York, New York, United States, 10021|
|Principal Investigator:||Jack Farr, MD||OrthoIndy|