Steroid Injection vs. BioDRestore for Patients With Knee OA

A Double-blind, Randomized Study Comparing Steroid Injection and BioDRestore for Patients With Knee Osteoarthritis

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.

Study Overview

• Status: Completed
• Conditions: Knee Osteoarthritis
• Intervention / Treatment: Device: BioD Restore; Drug: Kenalog

• Study Type: Interventional
• Enrollment (Actual): 90
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • South Carolina
    • Greenville, South Carolina, United States, 29615
      • Steadman Hawkins Clinic of the Carolinas

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Male or female, aged 18 to 80 years.
• Willing and able to give voluntary informed consent to participate in this investigation.
• Patient presents with knee osteoarthritis and Kellgren Lawrence grade 2-4 (OA diagnosed and confirmed by treating physician using standing x-ray).
• Candidate for intra-articular knee injection.
• BMI < 40

Exclusion Criteria:

• Patients who have received intra-articular injection(s) in the last 3 months.
• Patients who have undergone arthroscopic surgery on the study knee in the past year.
• Patients who have undergone arthroplasty on the study knee.
• Ligament instability
• Diabetes (Type 1 or II)
• Inflammatory arthropathies.
• Fibromyalgia or chronic fatigue syndrome.
• Female patient who is pregnant or nursing.
• Chronic use of narcotics.
• Any other reason (in the judgment of the investigator).

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: BioDRestore™; BioDRestore™ Elemental Tissue Matrix is a morselized, flowable tissue allograft derived from amniotic tissues. 2cc will be injected in the knee joint.	Device: BioD Restore; Investigational product, BioD Restore, will be injected into the articular space of the knee.
ACTIVE_COMPARATOR: Corticosteroid; Kenalog (40 mg of 40 mg/ml) will be the steroid utilized as the active comparator to be injected in the knee joint.	Drug: Kenalog; Active comparator, Kenalog steroid, will be injected into the articular space of the knee.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual Analog Pain Score	Patient reported level of pain on a scale of 0-10, with 10 being extreme pain and 0 being no pain.	Surgery through 12 months post-op/
Veterans Rand 12 Item Health Survey	Patient reported quality of life. Score contains a physical component and mental component score. Both scales are continuous and values range from 0 to 70, with higher scoring indicating higher physical and mental component scores	Sugery to 12 months post-op
Lysholm Knee Score	Patient reported knee function scores on a scale of 0-100, with 100 being a excellent outcome indicating no symptoms.	Surgery to 12 months post-op.
Single Alpha Numeric Evaluation (SANE)	Percentage of normal for affected knee between 0 to 100, with 100 being a perfectly "normal" knee and 0 being a completely "abnormal" knee.	Surgery to 12 months post-op.
Knee Injury and Osteoarthritis Outcome Score (KOOS)	Knee outcome measure assessed via Knee Injury and Osteoarthritis Outcome Score (KOOS) on a scale of 0 to 100. The higher score of 100 indicates a fully functional knee without knee pain or problems.	Surgery to 12 months post op

Collaborators and Investigators

• Sponsor: The Hawkins Foundation
• Collaborators: Integra LifeSciences Corporation
• Investigators: Principal Investigator: Paul Siffri, MD, Steadman Hawkins Clinic of the Carolinas - Greenville Health System

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 1, 2017
• Primary Completion (ACTUAL): January 1, 2020
• Study Completion (ACTUAL): January 1, 2020

Study Registration Dates

• First Submitted: May 5, 2016
• First Submitted That Met QC Criteria: May 9, 2016
• First Posted (ESTIMATE): May 10, 2016

Study Record Updates

• Last Update Posted (ACTUAL): November 23, 2021
• Last Update Submitted That Met QC Criteria: October 27, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee; Physiological Effects of Drugs; Anti-Inflammatory Agents; Immunosuppressive Agents; Immunologic Factors; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Triamcinolone Acetonide
• Other Study ID Numbers: Pro00048698

Plan for Individual participant data (IPD)

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