Platelet-rich Plasma vs. Hyaluronic Acid for Glenohumeral Osteoarthritis

Phase 4

Completed

Conditions: Osteoarthritis
Shoulder Pain

Interventions: Biological: PRP
Drug: Hyaluronic Acid
Device: Ultrasound

Registration Number: NCT02984228

Lead Sponsor: 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.

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 70

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Platelet-rich plasma (PRP)	PRP	Patients will receive an injection of PRP.
Platelet-rich plasma (PRP)	Ultrasound	Patients will receive an injection of PRP.
Hyaluronic Acid	Ultrasound	Patients will receive an injection of hyaluronic acid.
Hyaluronic Acid	Hyaluronic Acid	Patients will receive an injection of hyaluronic acid.

Primary Outcome Measures

Name	Time	Method
Shoulder Pain and Disability Index (SPADI) Score	Up to 52 weeks post-procedure	Score ranges from 0-100, with a higher score representing higher disability.

Secondary Outcome Measures

Name	Time	Method
Shoulder Function	Up to 52 weeks post-procedure	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	Up to 52 weeks post-procedure	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	Up to 52 weeks post-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.