Institutional Review Board, Hospital for Special Surgery
The safety of study participants is our top priority. The trial is approved and periodically reviewed by an Institutional Review Board (IRB), which includes doctors, administrators, ethicists, and members of the general public. The safety of clinical trials is reviewed by the U.S. Food and Drug Administration.
Before enrolling in a clinical trial, the investigator will explain the purpose of the trial, its expected benefits, any possible risks or side effects, and what your role will be. This is the time to ask questions! If you want to join the trial, you must sign the informed consent documents. You can leave a clinical trial at any time without penalty.
For further information, see Understanding Clinical Trials.
This study is investigating how effective platelet rich plasma (PRP) and hyaluronic acid (HA) injections are at improving symptoms associated with glenohumeral (shoulder) osteoarthritis. These two treatments have been used for osteoarthritis of other joints but have not been directly studied in the shoulder joint. These treatments may be options patients that have not improved with other conservative therapies and cannot or do not want to have surgery.
Glenohumeral osteoarthritis is a condition that occurs when shoulder cartilage is damaged or worn down and causes shoulder joints to become inflamed. This degenerative process often starts with an injury that gradually makes shoulders more painful and stiff over the course of several months or years.
PRP is prepared from your own blood and contains high amounts of concentrated growth factors that can stimulate healing and reduce inflammation.
HA is a naturally occurring lubricant in your shoulder joint that helps preserve healthy cartilage and also may be anti-inflammatory.
Participants will have a 50/50 chance of receiving an injection of PRP or HA to their affected shoulder joints and will not know which treatment they received for the duration of study participation (6 months). On the day of the injection as well as 1, 2, 3, and 6 months after the injection, participants will be asked to complete a questionnaire that will help us understand how your shoulder pain and function has changed over time. Each questionnaire will take approximately 15 minutes to complete.
· Glenohumeral OA confirmed on MRI within past 6 months
· Pain (≥ 5/10 on VAS) from 1˚ or 2˚ glenohumeral OA
· ≥ 3 months of pain persisting after conservative treatment (including corticosteroid injection)
· Clearance to abstain from aspirin for one week prior to the study procedure and 6 weeks after, if currently on aspirin regimen
· 18-100 years old
· English speaking/literate
· Painful active, concurrent cervical spine conditions
· Coagulopathy, bleeding dyscrasia, or platelet count <150,000/cubic mm
· Current NSAID use (can be held for study)
· Allergy to poultry or viscosupplementation
· Corticosteroid injection to affected shoulder within past 3 months
· Viscosupplementation or PRP injection to affected shoulder within past 6 months
· Presence of acute fracture
· History of shoulder tumor
· Known uncontrolled systemic illness
· Psychiatric and somatoform disorders
· Workers’ compensation or active litigation involving affected shoulder
· Non-English speaking/illiterate
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