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ReNu™ Marrow Stimulation Augmentation | Clinical Trials | Clareo Health

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ReNu™ Marrow Stimulation Augmentation

Evaluation of the ReNu™ Amniotic Suspension Allograft After Marrow Stimulation in the Treatment of Osteochondral Defects

NCT03036878•NuTech Medical, Inc

View on ClinicalTrials.gov

Summary

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

Detailed 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.

Eligibility

Age

18 - 55 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Voluntary signature of the IRB approved Informed Consent
•2. Male or female participants between the ages of 18-55
•3. If female:
•1. Actively practicing a contraception method, or
•2. Practicing abstinence, or
•3. Surgically sterilized, or
•4. Postmenopausal
•4. Pretreatment arthroscopic confirmation indicating one or two contained lesion(s) and equal to an ICRS Grade 3a, 3b, 3c, 3d of the femoral condyle, patella, or trochlear groove and OCD lesions (Grade 4a) with healed bone base, which is non-sclerotic and no loss of bone greater then 6mm measured from the surrounding subchondral plate. Original pretreatment arthroscopic confirmation indicates that one or two lesion(s) are equal to an ICRS Grade 3a, 3b, 3c, 3d contained lesion(s) that is equivalent to an Outerbridge Grade III or IV (greater than 50% loss of articular cartilage). OF NOTE: Patients with need for concomitant procedures such as Anteromedialization of Tibial Tubercle (AMZ) and lateral lengthening are allowable
•5. Has peripheral cartilage debridement to healthy cartilage that results in a lesion (s) with an area of \> or = 1cm \^2 and \< or = 4 cm\^2.
•6. PCL, LCL and MCL in the affected knee are stable and the ACL is stable or can be stabilized as a concomitant procedure.
+5 more criteria

Exclusion Criteria

•1. Clinical and/or radiographic disease diagnosis of the indexed affected joint that Includes:
•1. Osteoarthritis or avascular necrosis,
•2. Rheumatoid arthritis, or history of septic or reactive arthritis,
•3. Gout or history of gout or pseudogout in the affected knee,
•4. Osteochondritis dissecans of the knee with significant bone loss (greater than 6mm deep from the subchondral plate)
•5. Associated damage to the underlying subchondral bone requiring a bone graft
•2. History of secondary arthropathies (i.e. sickle cell disease, hemochromatosis, or autoimmune disease).
•3. Uncontrolled diabetes.
•4. Displays a high surgical risk due to unstable cardiac and/or pulmonary disease.
•5. Has HIV or other immunodeficient state including subjects on immunosuppressant therapies, or has significant illness (metastasis of any type) that decreases the probability of survival to the 2 year endpoint.
+17 more criteria

Locations (2)

Orthoindy

Indianapolis, Indiana, United States

Hospital for Special Surgery

New York, New York, United States

Key Dates

Start Date

February 7, 2017

Primary Completion Date

December 6, 2019

Completion Date

December 6, 2019

Last Updated

January 18, 2020

Enrollment

ACTUAL participants

Conditions

Osteochondral Defect

Interventions

ReNu

OTHER

BioPoly® Partial Resurfacing Knee Implant IDE

NCT06915363

Knee Pain ChronicKnee Osteoarthritis+4 more

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RECRUITING

Knee Registry (Knieregister)

NCT04364334

Knee PathologyOsteoarthritis, Knee+3 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 18, 2020Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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ReNu™ Marrow Stimulation Augmentation

Inclusion Criteria

Exclusion Criteria

BioPoly® Partial Resurfacing Knee Implant IDE

Knee Registry (Knieregister)

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