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An Investigation of ReNu™ Knee Injection in Patients With Osteoarthritis

NCT02318511 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2020-01-18

No results posted yet for this study

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.

Conditions

Interventions

PROCEDURE

Knee injection

Injection into knee for the treatment of Osteoarthritis

OTHER

ReNu amniotic allograft

DEVICE

placebo saline

DEVICE

Hyaluronic Acid

Sponsors & Collaborators

  • Organogenesis

    collaborator INDUSTRY

  • NuTech Medical, Inc

    lead INDUSTRY

Principal Investigators

  • Jack Farr, MD · OrthoIndy

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-06-30
Primary Completion
2019-01-31
Completion
2019-02-28

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02318511 on ClinicalTrials.gov