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Platelet-rich Plasma vs. Hyaluronic Acid for Glenohumeral Osteoarthritis

Hospital for Special Surgery (HSS) logo

Hospital for Special Surgery (HSS)

Status and phase

Completed
Phase 4

Conditions

Shoulder Pain
Osteoarthritis

Treatments

Drug: Hyaluronic Acid
Biological: PRP
Device: Ultrasound

Study type

Interventional

Funder types

Other

Identifiers

NCT02984228
2015-188

Details and patient eligibility

About

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.

Full 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.

Enrollment

70 patients

Sex

All

Ages

18 to 100 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

70 participants in 2 patient groups

Platelet-rich plasma (PRP)
Active Comparator group
Description:
Patients will receive an injection of PRP.
Treatment:
Biological: PRP
Device: Ultrasound
Hyaluronic Acid
Active Comparator group
Description:
Patients will receive an injection of hyaluronic acid.
Treatment:
Drug: Hyaluronic Acid
Device: Ultrasound

Trial documents
1

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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