Platelet-rich Plasma vs. Hyaluronic Acid for Glenohumeral Osteoarthritis

Osteoarthritis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02984228
• Other study ID #: 2015-188
• Status: Completed
• Phase: Phase 4
• Start date: December 2014
• Est. completion date: November 2020

Study information

• Verified date: August 2022
• Source: Hospital for Special Surgery, New York
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: November 2020
• Est. primary completion date: November 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Osteoarthritis
• Shoulder Pain

Intervention

Biological:
• PRP

Drug:
• Hyaluronic Acid

Device:
• Ultrasound

Locations

Country	Name	City	State
United States	Hospital for Special Surgery	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Hospital for Special Surgery, New York

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Shoulder Pain and Disability Index (SPADI) Score	Score ranges from 0-100, with a higher score representing higher disability.	Up to 52 weeks post-procedure
Secondary	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.	Up to 52 weeks post-procedure
Secondary	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".	Up to 52 weeks post-procedure
Secondary	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.	Up to 52 weeks post-procedure