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Steroid Injection vs. BioDRestore for Patients With Knee OA

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02767492
Recruitment Status : Completed
First Posted : May 10, 2016
Last Update Posted : April 10, 2020
Integra LifeSciences Corporation
Information provided by (Responsible Party):
The Hawkins Foundation

Brief 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.

Condition or disease Intervention/treatment Phase
Knee Osteoarthritis Device: BioD Restore Drug: Kenalog Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Double-blind, Randomized Study Comparing Steroid Injection and BioDRestore for Patients With Knee Osteoarthritis
Actual Study Start Date : January 2017
Actual Primary Completion Date : January 2020
Actual Study Completion Date : January 2020

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.

Primary Outcome Measures :
  1. Patient reported level of pain [ Time Frame: 12 months ]
    Pain assessed via Visual Analog Score (VAS).

  2. Patient reported overall quality of life measures [ Time Frame: 12 months ]
    Quality of life assessed via Veterans RAND 12 Item Health Survey (VR-12).

  3. Knee function [ Time Frame: 12 months ]
    Knee function assessed via Lysholm Knee Score.

  4. Normalcy [ Time Frame: 12 months ]
    Percentage of normal for affected knee assessed via Single Assessment Numeric Evaluation (SANE).

  5. Knee Outcome Measure [ Time Frame: 12 months ]
    Knee outcome measure assessed via Knee Injury and Osteoarthritis Outcome Score (KOOS).

Secondary Outcome Measures :
  1. Inflammatory Markers [ Time Frame: 6 months ]
    Inflammatory markers in synovial fluid of affected knee.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02767492

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United States, South Carolina
Steadman Hawkins Clinic of the Carolinas
Greenville, South Carolina, United States, 29615
Sponsors and Collaborators
The Hawkins Foundation
Integra LifeSciences Corporation
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Principal Investigator: Paul Siffri, MD Steadman Hawkins Clinic of the Carolinas - Greenville Health System
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Responsible Party: The Hawkins Foundation Identifier: NCT02767492    
Other Study ID Numbers: Pro00048698
First Posted: May 10, 2016    Key Record Dates
Last Update Posted: April 10, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Osteoarthritis, Knee
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Triamcinolone Acetonide
Anti-Inflammatory Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Immunosuppressive Agents
Immunologic Factors