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Knee Joint Osteoarthritis Treatment Study

Clinical Trial Title: 
Post-market investigation of ReNu tissue for I/A knee injection in patients with osteoarthritis.
Clinical Trial Protocol ID: 
15050704-IRB02
Clinical Trial Investigator Name: 
Brian J. Cole, MD, MBA; Adam B. Yanke, MD; Nikhil N. Verma, MD; Kathleen M. Weber, MD
Clinical Trial Protocol Description: 

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 one of three groups for injection into the affected knee, as follows:

  1. ReNu — study treatment
  2. Hyaluronic acid (HA) injection — with commonly used injection material
  3. Saline

After treatment, patients will be followed up to 12 months to evaluate improvements using common pain and function subscales.

Clinical Trial Eligibility Criteria: 

In order to participate you must meet the following criteria:

  • Be age 18 and older.
  • Have osteoarthritis of knee on Kellgren-Lawrence grade 2 or 3.

You will be excluded from the study if any of the following criteria apply to you:

  • Had pain medication (including NSAIDs) less than 15 days before injection. (May take acetaminophen.)
  • Have symptoms of locking, intermittent block to range of motion or loose body sensation which could indicate meniscal displacement or an intraarticular loose body.
  • Had corticosteroid injection in past three months.
  • Had viscosupplement injection in past three months.
  • Had knee surgery in last 12 months.
  • Had knee surgery for contralateral knee pain in the last six months.

This is a partial list of inclusion and exclusion criteria.

Clinical Trial Area: 
Orthopedic Conditions
Contact Phone: 
(312) 563-2214
Contact Name: 
Kavita Ahuja