An Investigation of ReNu™ Knee Injection in Patients With Osteoarthritis

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.

Study Overview

• Status: Completed
• Conditions: Osteoarthritis
• Intervention / Treatment: Procedure: Knee injection; Other: ReNu amniotic allograft; Device: placebo saline; Device: Hyaluronic Acid

• Study Type: Interventional
• Enrollment (Actual): 200
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35205
      • American Sports Medicine Institute
  • California
    • Los Angeles, California, United States, 90048
      • Cedars-Sinai Medical Center
  • Illinois
    • Chicago, Illinois, United States, 60612
      • Midwest Orthopedics at Rush, LLC
  • Indiana
    • Indianapolis, Indiana, United States, 46143
      • OrthoIndy
  • Kentucky
    • Lexington, Kentucky, United States, 40536-2093
      • Center for Clinical and Translational Science UK Chandler Medical Center, Pavilion H
  • Massachusetts
    • Chestnut Hill, Massachusetts, United States, 02467
      • Brigham and Women's Hospital
  • Missouri
    • Columbia, Missouri, United States, 65212
      • Missouri Orthopaedic Institute (MOI)
  • New Mexico
    • Albuquerque, New Mexico, United States, 87106
      • New Mexico Orthopaedics
  • New York
    • New York, New York, United States, 10021
      • Hospital For Special Surgery
    • New York, New York, United States, 10003
      • New York University
  • Ohio
    • Columbus, Ohio, United States, 43221
      • The Ohio State University
  • Virginia
    • Richmond, Virginia, United States, 23294
      • Advanced Orthopedics

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

3

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
VAS Pain Scale Change from Baseline	3 months
VAS Pain Scale Change from Baseline	6 months
KOOS Pain and Function Subscales Change from Baseline	3 months
KOOS Pain and Function Subscales Change from Baseline	6 months

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: NuTech Medical, Inc
• Collaborators: Organogenesis

Study record dates

Study Major Dates

• Study Start: June 1, 2015
• Primary Completion (ACTUAL): January 1, 2019
• Study Completion (ACTUAL): February 1, 2019

Study Registration Dates

• First Submitted: December 9, 2014
• First Submitted That Met QC Criteria: December 16, 2014
• First Posted (ESTIMATE): December 17, 2014

Study Record Updates

• Last Update Posted (ACTUAL): January 18, 2020
• Last Update Submitted That Met QC Criteria: January 14, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Physiological Effects of Drugs; Immunologic Factors; Protective Agents; Adjuvants, Immunologic; Viscosupplements; Hyaluronic Acid
• Other Study ID Numbers: RD2014-10-04

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO