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Platelet-rich Plasma vs. Hyaluronic Acid for Glenohumeral Osteoarthritis

Primary Purpose

Osteoarthritis, Shoulder Pain

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
PRP
Hyaluronic Acid
Ultrasound
Sponsored by
Hospital for Special Surgery, New York
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthritis

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Hospital for Special Surgery

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Platelet-rich plasma (PRP)

Hyaluronic Acid

Arm Description

Patients will receive an injection of PRP.

Patients will receive an injection of hyaluronic acid.

Outcomes

Primary Outcome Measures

Shoulder Pain and Disability Index (SPADI) Score
Score ranges from 0-100, with a higher score representing higher disability.

Secondary Outcome Measures

Shoulder Function
Shoulder function will be assessed using the American Shoulder and Elbow Surgeons Society Standardized Shoulder Assessment (ASES) Form. The ASES forms includes questions about difficulty performing different functions, such as putting on a coat and sleeping on the affected side. Scores range from 0 to 100, with a higher score indicating higher function and a lower score indicating lower function.
Number of Patients Who Were Satisfied After Treatment
Satisfaction will be assessed using the North American Spine Society Patient Satisfaction Index. Patients were asked to select one of the following in regards to the procedure: "The procedure met my expectations"; "The procedure improved my condition enough so that I would go through it again for the same outcome"; "The procedure helped me, but I would not go through it again for the same outcome"; or "I am the same or worse compared to before the procedure". Responses of "The procedure met my expectations" and "The procedure improved my condition enough so that I would go through it again for the same outcome" were considered to be "satisfied". The other two responses were considered to be "not satisfied".
Number of Patients With Complication Events After the Procedure
Any complications reported were collected. Complications include bleeding from the injection site, prolonged swelling, infection, weakness of the muscles surrounding the injected joint, and allergic reactions. Total number of available events was calculated by multiplying the number of patients with the number of follow-up time points. The percentage of complication events was calculated by summing the number of complication events and dividing that by the total number of available events, and then multiplying by 100.

Full Information

First Posted
December 1, 2016
Last Updated
August 5, 2022
Sponsor
Hospital for Special Surgery, New York
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1. Study Identification

Unique Protocol Identification Number
NCT02984228
Brief Title
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

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
December 2014 (Actual)
Primary Completion Date
November 2020 (Actual)
Study Completion Date
November 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospital for Special Surgery, New York

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Shoulder Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
70 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Platelet-rich plasma (PRP)
Arm Type
Active Comparator
Arm Description
Patients will receive an injection of PRP.
Arm Title
Hyaluronic Acid
Arm Type
Active Comparator
Arm Description
Patients will receive an injection of hyaluronic acid.
Intervention Type
Biological
Intervention Name(s)
PRP
Intervention Type
Drug
Intervention Name(s)
Hyaluronic Acid
Intervention Type
Device
Intervention Name(s)
Ultrasound
Primary Outcome Measure Information:
Title
Shoulder Pain and Disability Index (SPADI) Score
Description
Score ranges from 0-100, with a higher score representing higher disability.
Time Frame
Up to 52 weeks post-procedure
Secondary Outcome Measure Information:
Title
Shoulder Function
Description
Shoulder function will be assessed using the American Shoulder and Elbow Surgeons Society Standardized Shoulder Assessment (ASES) Form. The ASES forms includes questions about difficulty performing different functions, such as putting on a coat and sleeping on the affected side. Scores range from 0 to 100, with a higher score indicating higher function and a lower score indicating lower function.
Time Frame
Up to 52 weeks post-procedure
Title
Number of Patients Who Were Satisfied After Treatment
Description
Satisfaction will be assessed using the North American Spine Society Patient Satisfaction Index. Patients were asked to select one of the following in regards to the procedure: "The procedure met my expectations"; "The procedure improved my condition enough so that I would go through it again for the same outcome"; "The procedure helped me, but I would not go through it again for the same outcome"; or "I am the same or worse compared to before the procedure". Responses of "The procedure met my expectations" and "The procedure improved my condition enough so that I would go through it again for the same outcome" were considered to be "satisfied". The other two responses were considered to be "not satisfied".
Time Frame
Up to 52 weeks post-procedure
Title
Number of Patients With Complication Events After the Procedure
Description
Any complications reported were collected. Complications include bleeding from the injection site, prolonged swelling, infection, weakness of the muscles surrounding the injected joint, and allergic reactions. Total number of available events was calculated by multiplying the number of patients with the number of follow-up time points. The percentage of complication events was calculated by summing the number of complication events and dividing that by the total number of available events, and then multiplying by 100.
Time Frame
Up to 52 weeks post-procedure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jonathan Kirschner, MD
Organizational Affiliation
Hospital for Special Surgery, New York
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital for Special Surgery
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States

12. IPD Sharing Statement

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Platelet-rich Plasma vs. Hyaluronic Acid for Glenohumeral Osteoarthritis

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