Platelet-rich Plasma vs. Hyaluronic Acid for Glenohumeral Osteoarthritis

NCT ID: NCT02984228

Last Updated: 2022-08-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-12-31
• Study Completion Date: 2020-11-30

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.

Conditions

Osteoarthritis; Shoulder Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Platelet-rich plasma (PRP)

Patients will receive an injection of PRP.

Group Type: ACTIVE_COMPARATOR

PRP

Intervention Type: BIOLOGICAL

Ultrasound

Intervention Type: DEVICE

Hyaluronic Acid

Patients will receive an injection of hyaluronic acid.

Group Type: ACTIVE_COMPARATOR

Hyaluronic Acid

Intervention Type: DRUG

Ultrasound

Intervention Type: DEVICE

Interventions

PRP

Intervention Type: BIOLOGICAL

Hyaluronic Acid

Intervention Type: DRUG

Ultrasound

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospital for Special Surgery, New York

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jonathan Kirschner, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital for Special Surgery, New York

Locations

Hospital for Special Surgery

New York, New York, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

2015-188

Identifier Type: -

Identifier Source: org_study_id