NCT02318511

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

12 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 9, 2014

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 17, 2014

Completed
6 months until next milestone

Study Start

First participant enrolled

June 1, 2015

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2019

Completed
Last Updated

January 18, 2020

Status Verified

January 1, 2020

Enrollment Period

3.6 years

First QC Date

December 9, 2014

Last Update Submit

January 14, 2020

Conditions

Osteoarthritis

Outcome Measures

Primary Outcomes (4)

  • 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 Outcomes (3)

  • 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

Study Arms (3)

ReNu amniotic allograft

EXPERIMENTAL

Knee injection with ReNu. ReNu is an allograft tissue composed of particularized amniotic membrane and cell from the amniotic fluid.

Procedure: Knee injectionOther: ReNu amniotic allograft

Saline

PLACEBO COMPARATOR

Knee injection with saline. Injectable saline will be used as the placebo control.

Procedure: Knee injectionDevice: placebo saline

HA injection

ACTIVE COMPARATOR

Knee injection with HA. HA will be used as a viscosupplementation injection consisting of cross linked HA.

Procedure: Knee injectionDevice: Hyaluronic Acid

Interventions

Knee injectionPROCEDURE

Injection into knee for the treatment of Osteoarthritis

HA injectionReNu amniotic allograftSaline
ReNu amniotic allograftOTHER
ReNu amniotic allograft
placebo salineDEVICE
Saline
Hyaluronic AcidDEVICE
HA injection

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

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
  • 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
  • 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
  • +5 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (12)

American Sports Medicine Institute

Birmingham, Alabama, 35205, United States

Location

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

Location

Midwest Orthopedics at Rush, LLC

Chicago, Illinois, 60612, United States

Location

Orthoindy

Indianapolis, Indiana, 46143, United States

Location

Center for Clinical and Translational Science UK Chandler Medical Center, Pavilion H

Lexington, Kentucky, 40536-2093, United States

Location

Brigham and Women's Hospital

Chestnut Hill, Massachusetts, 02467, United States

Location

Missouri Orthopaedic Institute (MOI)

Columbia, Missouri, 65212, United States

Location

New Mexico Orthopaedics

Albuquerque, New Mexico, 87106, United States

Location

New York University

New York, New York, 10003, United States

Location

Hospital for Special Surgery

New York, New York, 10021, United States

Location

The Ohio State University

Columbus, Ohio, 43221, United States

Location

Advanced Orthopedics

Richmond, Virginia, 23294, United States

Location

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Officials

  • Jack Farr, MD

    OrthoIndy

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 9, 2014

First Posted

December 17, 2014

Study Start

June 1, 2015

Primary Completion

January 1, 2019

Study Completion

February 1, 2019

Last Updated

January 18, 2020

Record last verified: 2020-01

Data Sharing

IPD Sharing
Will not share

Locations

US(12)