OsteoarthritisPhase 4NCT02984228
Platelet-rich Plasma vs. Hyaluronic Acid for Glenohumeral Osteoarthritis
A Phase 4 study testing PRP, Hyaluronic Acid and Ultrasound in people with Osteoarthritis and Shoulder Pain, run by Hospital for Special Surgery, New York at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Osteoarthritis, Shoulder Pain
- What is being tested?
- PRP, Hyaluronic Acid and Ultrasound
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2014to Nov 2020
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Hospital for Special Surgery
New York, New York, 10021
About this study
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
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.
Read the 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
- Being tested
- PRP, Hyaluronic Acid, Ultrasound
- Medical subject headings
- Osteoarthritis, Shoulder Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PRPBiological
Hyaluronic AcidDrug
UltrasoundDevice
| Study group | Role | What they receive |
|---|---|---|
| Platelet-rich plasma (PRP) | Active comparator | Patients will receive an injection of PRP. Receives: Biological: PRP; Device: Ultrasound |
| Hyaluronic Acid | Active comparator | Patients will receive an injection of hyaluronic acid. Receives: Drug: Hyaluronic Acid; Device: Ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Shoulder Pain and Disability Index (SPADI) Score
Score ranges from 0-100, with a higher score representing higher disability.
Measured: Up to 52 weeks post-procedure
Secondary outcomes (3)
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.
Measured: Up to 52 weeks post-procedure
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".
Measured: Up to 52 weeks post-procedure
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.
Measured: Up to 52 weeks post-procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2016 (estimated)
- Study startDec 2014
- Primary completionNov 2020
- Study completionNov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for OsteoarthritisStudies of the same condition, open and under way.
- More trials run by Hospital for Special Surgery, New YorkThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital for Special Surgery, New York
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jonathan Kirschner, MD, Principal investigator, Hospital for Special Surgery, New York
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02984228
- Sponsor's protocol ID
- 2015-188
- Status last verified
- Aug 2022
- First submitted
- 1 Dec 2016
- Last updated
- 8 Aug 2022
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02984228
- Acronym / sponsor ID
- 2015-188
- Conditions
- Osteoarthritis, Shoulder Pain
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Hospital for Special Surgery, New YorkUniversity, hospital or other
- Study start
- Dec 2014 (actual)
- Primary completion
- Nov 2020 (actual)
- Study completion
- Nov 2020 (actual)
- First posted
- 6 Dec 2016 (estimated)
- Results
- Posted 8 Aug 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Platelet-rich plasma (PRP) | Active comparator | Biological: PRP, Device: UltrasoundPatients will receive an injection of PRP. |
| Hyaluronic Acid | Active comparator | Drug: Hyaluronic Acid, Device: UltrasoundPatients will receive an injection of hyaluronic acid. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PRP | Biological | Platelet-rich plasma (PRP) |
| Hyaluronic Acid | Drug | Hyaluronic Acid |
| Ultrasound | Device | Hyaluronic Acid, Platelet-rich plasma (PRP) |
Primary outcome
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.
3 secondary outcomes
Shoulder Function
Time frame: Up to 52 weeks post-procedure
Number of Patients Who Were Satisfied After Treatment
Time frame: Up to 52 weeks post-procedure
Number of Patients With Complication Events After the Procedure
Time frame: Up to 52 weeks post-procedure
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jonathan Kirschner, MD principal investigator
Hospital for Special Surgery, New York
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing PRP, Hyaluronic Acid and Ultrasound in people with Osteoarthritis and Shoulder Pain, run by Hospital for Special Surgery, New York at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 Aug 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Shoulder Pain and Disability Index (SPADI) Score (time frame: Up to 52 weeks post-procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Aug 2022.