Phase 4
N=70
Platelet-rich Plasma vs. Hyaluronic Acid for Glenohumeral Osteoarthritis
Osteoarthritis · Shoulder Pain
Bottom Line
View on ClinicalTrials.gov: NCT02984228 ↗Enrolled (actual)
70
Serious AEs
0.0%
Results posted
Aug 2022
Primary outcome: Primary: Shoulder Pain and Disability Index (SPADI) Score — 50.3; 49 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- PRP (Biological); Hyaluronic Acid (Drug); Ultrasound (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Hospital for Special Surgery, New York
- Primary completion
- Nov 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Shoulder Pain and Disability Index (SPADI) Score |
50.3; 49 | — |
| SECONDARY Shoulder Function |
57.8; 59 | — |
| SECONDARY Number of Patients Who Were Satisfied After Treatment |
20; 20 | — |
| SECONDARY Number of Patients With Complication Events After the Procedure |
11; 13 | — |
Summary
This study seeks to expand the current literature in demonstrating potentially efficacious, conservative treatments in the management of glenohumeral osteoarthritis (OA) and will compare ultrasound-guided injections of hyaluronic acid vs. platelet-rich plasma. We aim to obtain information measuring potential benefits of these interventions and to observe for any adverse events.
Eligibility Criteria
Inclusion Criteria
- English speaking/literate
- Age 18-100 years
- Visual analog score pain >= 5
- Greater than or equal to 3 months of pain after onset of symptoms that has failed conservative treatments
- Confirmation of glenohumeral OA via routine imaging (MRI and x-ray; must be recent and within the past year)
- Transient relief of symptoms after diagnostic intra-articular injection into the glenohumeral joint
Exclusion Criteria
- Non-English speaking/illiterate
- Painful active, concurrent cervical spine conditions
- Current non-steroidal anti-inflammatory drug (NSAID) use
- History of taking coumadin or similar anticoagulant, have a known coagulopathy, bleeding dyscrasia, or platelet count < 150,000/cubic mm
- Allergic reaction to poultry or previous viscosupplementation
- Involved in workers' compensation or active litigation involving affected shoulder
- Inability to refrain from NSAID use for 5 days prior to and 6 weeks after injection
- History of corticosteroid injection to affected shoulder within the last 3 months
- History of viscosupplementation or platelet-rich plasma to affected shoulder within the last 6 months
- Presence of acute fracture
- History of shoulder tumor
- Known uncontrolled systemic illness (uncontrolled diabetes, human immunodeficiency virus, vasculitis, autoimmune/inflammatory disease)
- Psychiatric and somatoform disorders
Data sourced from ClinicalTrials.gov (NCT02984228). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.