NCT03036878

ReNu™ Marrow Stimulation Augmentation

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

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 1 (actual)
• Sponsor: NuTech Medical, Inc · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Osteochondral Defect

Interventions

Type	Name	Description
OTHER	ReNu	ReNu is an allograft tissue composed of particularized amniotic membrane and cell from the amniotic fluid.

Timeline

• Start date: 2017-02-07
• Primary completion: 2019-12-06
• Completion: 2019-12-06
• First posted: 2017-01-30
• Last updated: 2020-01-18

Locations

2 sites across 1 country: United States