An Investigation of ReNu™ Knee Injection in Patients With Osteoarthritis

Sponsor

NuTech Medical, Inc (Industry)

Overall Status

Completed

CT.gov ID

NCT02318511

Collaborator

Organogenesis (Industry)

200

Enrollment

Locations

Arms

44.1

Duration (Months)

16.7

Patients Per Site

0.4

Patients Per Site Per Month

Study Details

Study Description

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	N/A

Study Design

Study Type:

Interventional

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 :

Jun 1, 2015

Actual Primary Completion Date :

Jan 1, 2019

Actual Study Completion Date :

Feb 1, 2019

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	American Sports Medicine Institute	Birmingham	Alabama	United States	35205
2	Cedars-Sinai Medical Center	Los Angeles	California	United States	90048
3	Midwest Orthopedics at Rush, LLC	Chicago	Illinois	United States	60612
4	Orthoindy	Indianapolis	Indiana	United States	46143
5	Center for Clinical and Translational Science UK Chandler Medical Center, Pavilion H	Lexington	Kentucky	United States	40536-2093
6	Brigham and Women's Hospital	Chestnut Hill	Massachusetts	United States	02467
7	Missouri Orthopaedic Institute (MOI)	Columbia	Missouri	United States	65212
8	New Mexico Orthopaedics	Albuquerque	New Mexico	United States	87106
9	New York University	New York	New York	United States	10003
10	Hospital for Special Surgery	New York	New York	United States	10021
11	The Ohio State University	Columbus	Ohio	United States	43221
12	Advanced Orthopedics	Richmond	Virginia	United States	23294

Sponsors and Collaborators

NuTech Medical, Inc
Organogenesis

Investigators

Principal Investigator: Jack Farr, MD, OrthoIndy

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

NuTech Medical, Inc

ClinicalTrials.gov Identifier:

NCT02318511

Other Study ID Numbers:

RD2014-10-04

First Posted:

Dec 17, 2014

Last Update Posted:

Jan 18, 2020

Last Verified:

Jan 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Additional relevant MeSH terms:

Osteoarthritis

Hyaluronic Acid

Study Results

No Results Posted as of Jan 18, 2020