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Trial record 1 of 1 for:    NCT02318511
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An Investigation of ReNu™ Knee Injection in Patients With Osteoarthritis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02318511
Recruitment Status : Completed
First Posted : December 17, 2014
Last Update Posted : January 18, 2020
Sponsor:
Collaborator:
Organogenesis
Information provided by (Responsible Party):
NuTech Medical, Inc

Brief 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.

Condition or disease Intervention/treatment Phase
Osteoarthritis Procedure: Knee injection Other: ReNu amniotic allograft Device: placebo saline Device: Hyaluronic Acid Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: An Investigation of ReNu™ Knee Injection: Monitoring the Response of Knee Function and Pain in Patients With Osteoarthritis
Study Start Date : June 2015
Actual Primary Completion Date : January 2019
Actual Study Completion Date : February 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

Arm Intervention/treatment
Experimental: ReNu amniotic allograft
Knee injection with ReNu. ReNu is an allograft tissue composed of particularized amniotic membrane and cell from the amniotic fluid.
Procedure: Knee injection
Injection into knee for the treatment of Osteoarthritis

Other: ReNu amniotic allograft
Placebo Comparator: Saline
Knee injection with saline. Injectable saline will be used as the placebo control.
Procedure: Knee injection
Injection into knee for the treatment of Osteoarthritis

Device: placebo saline
Active Comparator: HA injection
Knee injection with HA. HA will be used as a viscosupplementation injection consisting of cross linked HA.
Procedure: Knee injection
Injection into knee for the treatment of Osteoarthritis

Device: Hyaluronic Acid



Primary Outcome Measures :
  1. VAS Pain Scale Change from Baseline [ Time Frame: 3 months ]
  2. VAS Pain Scale Change from Baseline [ Time Frame: 6 months ]
  3. KOOS Pain and Function Subscales Change from Baseline [ Time Frame: 3 months ]
  4. KOOS Pain and Function Subscales Change from Baseline [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. KOOS Pain and Function Subscales change from Baseline [ Time Frame: 1 week, 6 weeks, 3 months, and 12 months ]
  2. Other patient reported outcomes (PROs) change from Baseline [ Time Frame: 1 week, 6 week, 3 months, 6 months, and 12 months ]
  3. Radiographic (X-ray) measurement of standing joint space change from Baseline [ Time Frame: 12 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02318511


Locations
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United States, Alabama
American Sports Medicine Institute
Birmingham, Alabama, United States, 35205
United States, California
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
United States, Illinois
Midwest Orthopedics at Rush, LLC
Chicago, Illinois, United States, 60612
United States, Indiana
Orthoindy
Indianapolis, Indiana, United States, 46143
United States, Kentucky
Center for Clinical and Translational Science UK Chandler Medical Center, Pavilion H
Lexington, Kentucky, United States, 40536-2093
United States, Massachusetts
Brigham and Women's Hospital
Chestnut Hill, Massachusetts, United States, 02467
United States, Missouri
Missouri Orthopaedic Institute (MOI)
Columbia, Missouri, United States, 65212
United States, New Mexico
New Mexico Orthopaedics
Albuquerque, New Mexico, United States, 87106
United States, New York
New York University
New York, New York, United States, 10003
Hospital for Special Surgery
New York, New York, United States, 10021
United States, Ohio
The Ohio State University
Columbus, Ohio, United States, 43221
United States, Virginia
Advanced Orthopedics
Richmond, Virginia, United States, 23294
Sponsors and Collaborators
NuTech Medical, Inc
Organogenesis
Investigators
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Principal Investigator: Jack Farr, MD OrthoIndy
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Responsible Party: NuTech Medical, Inc
ClinicalTrials.gov Identifier: NCT02318511    
Other Study ID Numbers: RD2014-10-04
First Posted: December 17, 2014    Key Record Dates
Last Update Posted: January 18, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Hyaluronic Acid
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Viscosupplements
Protective Agents