An Investigation of ReNu™ Knee Injection in Patients With Osteoarthritis



Status:Completed
Conditions:Arthritis, Osteoarthritis (OA)
Therapuetic Areas:Rheumatology
Healthy:No
Age Range:18 - Any
Updated:2/24/2019
Start Date:June 2015
End Date:February 2019

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

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.


Inclusion Criteria:

- 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

Exclusion Criteria:

- 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
We found this trial at
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Indianapolis, Indiana
Principal Investigator: Jack Farr, MD
Phone: 317-884-5230
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8700 Beverly Blvd # 8211
Los Angeles, California 90048
(1-800-233-2771)
Cedars Sinai Med Ctr Cedars-Sinai is known for providing the highest quality patient care. Our...
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Albuquerque, New Mexico 87106
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Birmingham, Alabama 35205
Principal Investigator: Jeffrey Davis, MD
Phone: 205-327-1077
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Chestnut Hill, Massachusetts 02467
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Chicago, Illinois 60612
Principal Investigator: Adam B Yanke, MD
Phone: 312-432-2440
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Columbia, Missouri 65212
Principal Investigator: Seth Sherman, MD
Phone: 573-884-4565
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281 W. Lane Ave
Columbus, Ohio 43210
(614) 292-6446
Principal Investigator: David Flanigan, MD
Phone: 614-293-7952
Ohio State University The Ohio State University’s main Columbus campus is one of America’s largest...
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Lexington, Kentucky 40536
Principal Investigator: Christian Latterman, MD
Phone: 859-323-2093
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Lexington, KY
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70 Washington Square S
New York, New York 10012
(212) 998-1212
Principal Investigator: Eric Strauss, MD
Phone: 212-598-6096
New York University More than 175 years ago, Albert Gallatin, the distinguished statesman who served...
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535 E 70th St
New York, New York 10021
(212) 606-1000
Principal Investigator: Sabrina Strickland, MD
Phone: 212-774-2449
Hospital for Special Surgery Founded in 1863, Hospital for Special Surgery is the nation
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Richmond, Virginia 23294
Principal Investigator: Kenneth Zaslav, MD
Phone: 804-270-1305
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