Platelet-rich Plasma vs. Hyaluronic Acid for Glenohumeral Osteoarthritis

NCT02984228 | Completed Phase 4 Results

• 1 other identifier: 2015-188
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteoarthritis; Shoulder Pain

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Shoulder Function

  Up to 52 weeks post-procedure

• Number of Patients Who Were Satisfied After Treatment

  Up to 52 weeks post-procedure

• Number of Patients With Complication Events After the Procedure

  Up to 52 weeks post-procedure

Study Arms (2)

Platelet-rich plasma (PRP)

ACTIVE COMPARATOR

Patients will receive an injection of PRP.

Biological: PRP; Device: Ultrasound

Hyaluronic Acid

ACTIVE COMPARATOR

Patients will receive an injection of hyaluronic acid.

Drug: Hyaluronic Acid; Device: Ultrasound

Interventions

PRP BIOLOGICAL

Platelet-rich plasma (PRP)

Hyaluronic Acid DRUG

Hyaluronic Acid

Ultrasound DEVICE

Hyaluronic Acid; Platelet-rich plasma (PRP)

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospital for Special Surgery, New York: lead

Study Sites (1)

Hospital for Special Surgery

New York, New York, 10021, United States

Location

MeSH Terms

Conditions

Osteoarthritis; Shoulder Pain

Interventions

Hyaluronic Acid; Ultrasonography

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthralgia; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Glycosaminoglycans; Polysaccharides; Carbohydrates; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Results Point of Contact

• Title: Jennifer Cheng
• Organization: Hospital for Special Surgery

chengj@hss.edu

6467146870

Study Officials

• Jonathan Kirschner, MD

  Hospital for Special Surgery, New York

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 1, 2016
• First Posted: December 6, 2016
• Study Start: December 1, 2014
• Primary Completion: November 1, 2020
• Study Completion: November 1, 2020
• Last Updated: August 8, 2022
• Results First Posted: August 8, 2022

Record last verified: 2022-08

Locations

US (1)