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Steroid Injection vs. BioDRestore for Patients With Knee OA

NCT02767492 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2021-11-23

Study results available
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Summary

This study will include patients who are diagnosed with knee OA and are recommended for a knee injection. Study subjects will be randomized to receive either the standard of care knee injection (steroid) or amniotic tissue injection (BioDRestore). Study subjects will be asked for permission for a baseline knee aspiration prior to the knee injection. At 6 months post-injection, knee aspirations will be taken and sent for analysis. Study subjects will be followed for 1 year post-injection to include range of motion measurements and patient-reported pain/functional outcome measurements. X-rays will also be taken at the 1-year post-injection appointment.

Conditions

  • Knee Osteoarthritis

Interventions

DEVICE

BioD Restore

Investigational product, BioD Restore, will be injected into the articular space of the knee.

DRUG

Kenalog

Active comparator, Kenalog steroid, will be injected into the articular space of the knee.

Sponsors & Collaborators

  • Integra LifeSciences Corporation

    collaborator INDUSTRY

  • The Hawkins Foundation

    lead OTHER

Principal Investigators

  • Paul Siffri, MD · Steadman Hawkins Clinic of the Carolinas - Greenville Health System

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-01-31
Primary Completion
2020-01-31
Completion
2020-01-31

Countries

  • United States

Study Locations

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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 NCT02767492 on ClinicalTrials.gov