NCT02767492

Steroid Injection vs. BioDRestore for Patients With Knee OA

A Double-blind, Randomized Study Comparing Steroid Injection and BioDRestore for Patients With Knee Osteoarthritis

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 90 (actual)
• Sponsor: The Hawkins Foundation · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This study will include patients who are diagnosed with knee OA and are recommended for a knee injection. Study subjects will be randomized to receive either the standard of care knee injection (steroid) or amniotic tissue injection (BioDRestore). Study subjects will be asked for permission for a baseline knee aspiration prior to the knee injection. At 6 months post-injection, knee aspirations will be taken and sent for analysis. Study subjects will be followed for 1 year post-injection to include range of motion measurements and patient-reported pain/functional outcome measurements. X-rays will also be taken at the 1-year post-injection appointment.

Conditions

• Knee Osteoarthritis

Interventions

Type	Name	Description
DEVICE	BioD Restore	Investigational product, BioD Restore, will be injected into the articular space of the knee.
DRUG	Kenalog	Active comparator, Kenalog steroid, will be injected into the articular space of the knee.

Timeline

• Start date: 2017-01-01
• Primary completion: 2020-01-01
• Completion: 2020-01-01
• First posted: 2016-05-10
• Last updated: 2021-11-23
• Results posted: 2021-11-23

Locations

1 site across 1 country: United States