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Platelet-rich Plasma vs. Hyaluronic Acid for Glenohumeral Osteoarthritis

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ClinicalTrials.gov Identifier: NCT02984228
Recruitment Status : Completed
First Posted : December 6, 2016
Last Update Posted : December 23, 2020
Sponsor:
Information provided by (Responsible Party):
Hospital for Special Surgery, New York

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.

Condition or disease Intervention/treatment Phase
Osteoarthritis Shoulder Pain Biological: PRP Drug: Hyaluronic Acid Device: Ultrasound Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

Arm Intervention/treatment
Active Comparator: Platelet-rich plasma (PRP)
Patients will receive an injection of PRP.
Biological: PRP
Device: Ultrasound
Active Comparator: Hyaluronic Acid
Patients will receive an injection of hyaluronic acid.
Drug: Hyaluronic Acid
Device: Ultrasound



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. Pain medication usage [ Time Frame: Up to 52 weeks post-procedure ]
  3. 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".

  4. Patient Satisfaction [ Time Frame: Up to 52 weeks post-procedure ]
    Satisfaction will be assessed using the North American Spine Society Patient Satisfaction Index.

  5. Complications [ Time Frame: Up to 52 weeks post-procedure ]
    Any complications reported will be collected.



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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

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


Locations
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United States, New York
Hospital for Special Surgery
New York, New York, United States, 10021
Sponsors and Collaborators
Hospital for Special Surgery, New York
Investigators
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Principal Investigator: Jonathan Kirschner, MD Hospital for Special Surgery, New York
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Responsible Party: Hospital for Special Surgery, New York
ClinicalTrials.gov Identifier: NCT02984228    
Other Study ID Numbers: 2015-188
First Posted: December 6, 2016    Key Record Dates
Last Update Posted: December 23, 2020
Last Verified: December 2020
Additional relevant MeSH terms:
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Osteoarthritis
Shoulder Pain
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Arthralgia
Pain
Neurologic Manifestations
Hyaluronic Acid
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Viscosupplements
Protective Agents