Clinical trial NCT02984228: Platelet-rich Plasma vs. Hyaluronic Acid for Glenohumeral Osteoarthritis
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Osteoarthritis
Shoulder Pain
Lead sponsor: Hospital for Special Surgery, New York
Sponsor class: OTHER
First posted: 2016-12-06
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: Glenohumeral OA accounts for approximately 2-5% of all chronic shoulder pain and may be classified into primary and secondary forms. Primary glenohumeral OA is caused by degenerative joint disease, inflammatory arthropathies, and neuropathic arthropathy secondary to syringomyelia or diabetes. Secondary glenohumeral OA is caused by trauma, postoperative changes after arthroscopy or capulorraphy, and osteonecrosis. Hyaluronic acid is found in synovial joint fluid and has viscoelastic, chondroprotective, and possibly anti-inflammatory properties. It has been shown to increase joint lubrication. Platelet-rich plasma contains growth factors that have been shown to promote tissue regeneration. The aim of this study is to determine whether injections of hyaluronic acid or platelet-rich plasma can be used reliably to decrease pain, restore function, and improve quality of life in patients suffering from glenohumeral OA. Patients will be randomized to receive either an injection of hyaluronic acid or an injection of platelet-rich plasma. Outcomes will be assessed via questionnaires for up to 52 weeks post-procedure.

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

Primary outcomes:
measure: Shoulder Pain and Disability Index (SPADI) Score
timeFrame: Up to 52 weeks post-procedure
Secondary outcomes:
measure: Shoulder Function
timeFrame: Up to 52 weeks post-procedure
measure: Number of Patients Who Were Satisfied After Treatment
timeFrame: Up to 52 weeks post-procedure
measure: Number of Patients With Complication Events After the Procedure
timeFrame: Up to 52 weeks post-procedure
Other outcomes:
Locations:
city: New York
country: United States
facility: Hospital for Special Surgery
state: New York
Study officials:
affiliation: Hospital for Special Surgery, New York
name: Jonathan Kirschner, MD
role: PRINCIPAL_INVESTIGATOR
References: