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.|
|ClinicalTrials.gov Identifier: NCT02767492|
Recruitment Status : Completed
First Posted : May 10, 2016
Last Update Posted : April 10, 2020
|Condition or disease||Intervention/treatment||Phase|
|Knee Osteoarthritis||Device: BioD Restore Drug: Kenalog||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||90 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|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|
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.
Active comparator, Kenalog steroid, will be injected into the articular space of the knee.
- Patient reported level of pain [ Time Frame: 12 months ]Pain assessed via Visual Analog Score (VAS).
- Patient reported overall quality of life measures [ Time Frame: 12 months ]Quality of life assessed via Veterans RAND 12 Item Health Survey (VR-12).
- Knee function [ Time Frame: 12 months ]Knee function assessed via Lysholm Knee Score.
- Normalcy [ Time Frame: 12 months ]Percentage of normal for affected knee assessed via Single Assessment Numeric Evaluation (SANE).
- Knee Outcome Measure [ Time Frame: 12 months ]Knee outcome measure assessed via Knee Injury and Osteoarthritis Outcome Score (KOOS).
- Inflammatory Markers [ Time Frame: 6 months ]Inflammatory markers in synovial fluid of affected knee.
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 ClinicalTrials.gov identifier (NCT number): NCT02767492
|United States, South Carolina|
|Steadman Hawkins Clinic of the Carolinas|
|Greenville, South Carolina, United States, 29615|
|Principal Investigator:||Paul Siffri, MD||Steadman Hawkins Clinic of the Carolinas - Greenville Health System|