An Investigation of ReNu™ Knee Injection in Patients With Osteoarthritis
NCT ID: NCT02318511
Last Updated: 2020-01-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
200 participants
INTERVENTIONAL
2015-06-30
2019-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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ReNu amniotic allograft
Knee injection with ReNu. ReNu is an allograft tissue composed of particularized amniotic membrane and cell from the amniotic fluid.
Knee injection
Injection into knee for the treatment of Osteoarthritis
ReNu amniotic allograft
Saline
Knee injection with saline. Injectable saline will be used as the placebo control.
Knee injection
Injection into knee for the treatment of Osteoarthritis
placebo saline
HA injection
Knee injection with HA. HA will be used as a viscosupplementation injection consisting of cross linked HA.
Knee injection
Injection into knee for the treatment of Osteoarthritis
Hyaluronic Acid
Interventions
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Knee injection
Injection into knee for the treatment of Osteoarthritis
ReNu amniotic allograft
placebo saline
Hyaluronic Acid
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
Yes
Sponsors
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Organogenesis
INDUSTRY
NuTech Medical, Inc
INDUSTRY
Responsible Party
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Principal Investigators
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Jack Farr, MD
Role: PRINCIPAL_INVESTIGATOR
OrthoIndy
Locations
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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
Countries
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Other Identifiers
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RD2014-10-04
Identifier Type: -
Identifier Source: org_study_id
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