Platelet-rich Plasma vs. Hyaluronic Acid for Glenohumeral Osteoarthritis
|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: NCT02984228|
Recruitment Status : Completed
First Posted : December 6, 2016
Last Update Posted : December 23, 2020
|Condition or disease||Intervention/treatment||Phase|
|Osteoarthritis Shoulder Pain||Biological: PRP Drug: Hyaluronic Acid Device: Ultrasound||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||70 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||The Efficacy of Ultrasound Guided Glenohumeral Joint Injections of Platelet Rich Plasma (PRP) Versus Hyaluronic Acid (HA) in the Treatment of Glenohumeral Osteoarthritis: a Randomized, Double-blind Control Trial|
|Actual Study Start Date :||December 2014|
|Actual Primary Completion Date :||November 2020|
|Actual Study Completion Date :||November 2020|
Active Comparator: Platelet-rich plasma (PRP)
Patients will receive an injection of PRP.
Active Comparator: Hyaluronic Acid
Patients will receive an injection of hyaluronic acid.
Drug: Hyaluronic Acid
- Shoulder Pain and Disability Index (SPADI) score [ Time Frame: Up to 52 weeks post-procedure ]Score ranges from 0-100, with a higher score representing higher disability.
- Shoulder Function [ Time Frame: Up to 52 weeks post-procedure ]Shoulder function will be assessed using the American Shoulder and Elbow Surgeons Society Standardized Shoulder Assessment Form.
- Pain medication usage [ Time Frame: Up to 52 weeks post-procedure ]
- Sleep quality [ Time Frame: Up to 52 weeks post-procedure ]Sleep quality will be assessed on a 0-10 scale, where 0="I could not sleep at all" and 10="I slept perfectly well".
- Patient Satisfaction [ Time Frame: Up to 52 weeks post-procedure ]Satisfaction will be assessed using the North American Spine Society Patient Satisfaction Index.
- Complications [ Time Frame: Up to 52 weeks post-procedure ]Any complications reported will be collected.
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): NCT02984228
|United States, New York|
|Hospital for Special Surgery|
|New York, New York, United States, 10021|
|Principal Investigator:||Jonathan Kirschner, MD||Hospital for Special Surgery, New York|