An Investigation of ReNu™ Knee Injection in Patients With Osteoarthritis

Completed · Not applicable · Has a placebo group

Conditions studied: Osteoarthritis

In brief

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.

Key facts

Study ID

NCT02318511

Run by

NuTech Medical, Inc

People needed

200

Starts

2015-06-01

Expected to finish

2019-02-01

Last updated by the study team

2020-01-18

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Patients with moderate knee osteoarthritis determined by a combination of clinical and radiographic findings and documented by Kellgren-Lawrence radiographic classification (Grade 2 or 3)
• Grade 2 Kellgren-Lawrence radiographic changes are defined as small osteophytes, possible narrowing of joint space
• Grade 3 Kellgren-Lawrence radiographic changes are defined as moderate multiple osteophytes, definite narrowing of joints space, some sclerosis and possible deformity of bone contour.
• Patients with bilateral grade 2 or 3 Kellgren Lawrence knee osteoarthritis who have bilateral symptoms may have their more symptomatic knee injected. If equivalent symptoms are reported by the patient, then the patient will choose which knee is to be injected. The contralateral knee can be treated with local standard of care such as steroid injection, cold therapy or soft brace.
• Age 18 and older
• BMI less than 40
• 7 day average pain score of 4 or greater for the involved knee on a numeric pain scale from 1 to 10.
• Female patients must be actively practicing a contraception method, abstinence, be surgically sterilized, or be postmenopausal

You may not qualify if…

• Pain medication (including nonsteroidal antiinflammatory drugs, NSAIDs) less than 15 days before injection (may take acetaminophen)
• Receiving pain medication other than acetaminophen for conditions unrelated to osteoarthritis of the index knee
• Regular use of anticoagulants, such as Coumadin, dabigatran or rivaroxaban; use of antiplatelet medications are not a reason for exclusion
• History of substance abuse.
• Failure to agree NOT to take additional knee symptom modifying drugs, other than acetaminophen, during the course of the study without reporting to the study team
• Pregnancy or desire to become pregnant during study duration
• Positive pregnancy test on premenopausal subject
• Morbid obesity (defined as BMI 40 or greater)
• Symptoms of locking, intermittent block to range of motion or loose body sensation which could indicate meniscal displacement or an intraarticular loose body
• Corticosteroid injection into the index knee within 3 months
• Viscosupplement injection into the index knee within 3 months
• Knee surgery of involved index knee within 12 months
• Knee surgery contralateral knee 6 months
• Worker compensation
• Acute index knee injury (injury within 3 months)
• History of Diabetes mellitus
• History of solid organ or hematologic transplantation
• History of rheumatoid arthritis or other autoimmune disorder
• Diagnosis of a non-basal cell malignancy within the preceding 5 years
• Infection requiring antibiotic treatment within the preceding 3 months
• Current therapy with any immunosuppressive medication, including corticosteroids at a dose > 5 mg per day

Where it is running

• American Sports Medicine Institute — Birmingham, Alabama, United States
• Cedars-Sinai Medical Center — Los Angeles, California, United States
• Midwest Orthopedics at Rush, LLC — Chicago, Illinois, United States
• Orthoindy — Indianapolis, Indiana, United States
• Center for Clinical and Translational Science UK Chandler Medical Center, Pavilion H — Lexington, Kentucky, United States
• Brigham and Women's Hospital — Chestnut Hill, Massachusetts, United States
• Missouri Orthopaedic Institute (MOI) — Columbia, Missouri, United States
• New Mexico Orthopaedics — Albuquerque, New Mexico, United States
• New York University — New York, New York, United States
• Hospital for Special Surgery — New York, New York, United States
• The Ohio State University — Columbus, Ohio, United States
• Advanced Orthopedics — Richmond, Virginia, United States

Full record on ClinicalTrials.gov

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