NCT02318511

An Investigation of ReNu™ Knee Injection in Patients With Osteoarthritis

An Investigation of ReNu™ Knee Injection: Monitoring the Response of Knee Function and Pain in Patients With Osteoarthritis

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (actual)
• Sponsor: NuTech Medical, Inc · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

This is a Prospective, Randomized study evaluating the efficacy of ReNu for the treatment of Kellgren-Lawrence grade 2 or 3 osteoarthritis. Patients will be randomized into 1 of 3 groups for injection into the effected knee: 1) ReNu - study treatment, 2) Hyaluronic Acid (HA) injection - with commonly used injection material and 3) Saline. After treatment, patients will be followed up to 12 months to evaluate improvements using common pain and function subscales.

Conditions

• Osteoarthritis

Interventions

Type	Name	Description
PROCEDURE	Knee injection	Injection into knee for the treatment of Osteoarthritis
OTHER	ReNu amniotic allograft
DEVICE	placebo saline
DEVICE	Hyaluronic Acid

Timeline

• Start date: 2015-06-01
• Primary completion: 2019-01-01
• Completion: 2019-02-01
• First posted: 2014-12-17
• Last updated: 2020-01-18

Locations

12 sites across 1 country: United States