- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02984228
Platelet-rich Plasma vs. Hyaluronic Acid for Glenohumeral Osteoarthritis
August 5, 2022 updated by: Hospital for Special Surgery, New York
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
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
70
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
New York
-
New York, New York, United States, 10021
- Hospital for Special Surgery
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 98 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Platelet-rich plasma (PRP)
Patients will receive an injection of PRP.
|
|
Active Comparator: Hyaluronic Acid
Patients will receive an injection of hyaluronic acid.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Shoulder Pain and Disability Index (SPADI) Score
Time Frame: Up to 52 weeks post-procedure
|
Score ranges from 0-100, with a higher score representing higher disability.
|
Up to 52 weeks post-procedure
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Shoulder Function
Time Frame: 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.
|
Up to 52 weeks post-procedure
|
Number of Patients Who Were Satisfied After Treatment
Time Frame: 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".
|
Up to 52 weeks post-procedure
|
Number of Patients With Complication Events After the Procedure
Time Frame: 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.
|
Up to 52 weeks post-procedure
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Jonathan Kirschner, MD, Hospital for Special Surgery, New York
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 1, 2014
Primary Completion (Actual)
November 1, 2020
Study Completion (Actual)
November 1, 2020
Study Registration Dates
First Submitted
December 1, 2016
First Submitted That Met QC Criteria
December 2, 2016
First Posted (Estimate)
December 6, 2016
Study Record Updates
Last Update Posted (Actual)
August 8, 2022
Last Update Submitted That Met QC Criteria
August 5, 2022
Last Verified
August 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2015-188
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Osteoarthritis
-
Sanford HealthActive, not recruitingKnee Osteoarthritis | Hip Osteoarthritis | Shoulder Osteoarthritis | Ankle Osteoarthritis | Wrist OsteoarthritisUnited States
-
University of EdinburghHospital for Special Surgery, New YorkRecruitingKnee Osteoarthritis | Hip Osteoarthritis | Shoulder OsteoarthritisUnited Kingdom
-
Medical University of WarsawUnknownOsteoarthritis | Knee Osteoarthritis | Hip Osteoarthritis | Glenohumeral OsteoarthritisPoland
-
Medical University of WarsawUnknownOsteoarthritis | Knee Osteoarthritis | Hip Osteoarthritis | Glenohumeral OsteoarthritisPoland
-
University of California, San FranciscoStanford University; Robert Wood Johnson FoundationCompletedKnee Osteoarthritis | Hip OsteoarthritisUnited States
-
University of VermontCompletedOsteoarthritis of Knee | Osteoarthritis Of HipUnited States
-
Hospital for Special Surgery, New YorkRoyal Infirmary of EdinburghRecruitingKnee Osteoarthritis | Hip Osteoarthritis | Shoulder OsteoarthritisUnited States, United Kingdom
-
Ottawa Hospital Research InstituteNot yet recruitingKnee Osteoarthritis | Hip Osteoarthritis
-
University Hospital, LilleCompleted
-
Massachusetts General HospitalNewton-Wellesley Hospital; The New England Baptist HospitalCompletedKnee Osteoarthritis | Hip OsteoarthritisUnited States
Clinical Trials on Ultrasound
-
Ahram Canadian UniversityCompletedCarpal Tunnel Syndrome | Median Neuropathy, Carpal TunnelEgypt
-
Eskisehir Osmangazi UniversityCompletedCarpal Tunnel Syndrome
-
Cairo UniversityUnknown
-
Ohio State University Comprehensive Cancer CenterWithdrawn
-
M.D. Anderson Cancer CenterNational Cancer Institute (NCI)Withdrawn
-
Mayo ClinicNational Cancer Institute (NCI); National Institute for Biomedical Imaging...RecruitingBreast CarcinomaUnited States
-
Bursa Yüksek İhtisas Education and Research HospitalNot yet recruitingShoulder Impingement Syndrome | Shoulder Pain
-
John PelleritoGeneral ElectricActive, not recruiting
-
Oregon Health and Science UniversityRecruiting
-
Yale UniversityCompletedPneumonia | Pulmonary Edema | DyspneaUnited States