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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Platelet-rich plasma (PRP) | Active Comparator | Patients will receive an injection of PRP. |
|
| Hyaluronic Acid | Active Comparator | Patients will receive an injection of hyaluronic acid. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PRP | Biological |
| ||
| Hyaluronic Acid |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jonathan Kirschner, MD | Hospital for Special Surgery, New York | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital for Special Surgery | New York | New York | 10021 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Platelet-rich Plasma (PRP) | Patients will receive an injection of PRP. PRP Ultrasound |
| FG001 | Hyaluronic Acid | Patients will receive an injection of hyaluronic acid. Hyaluronic Acid Ultrasound |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Platelet-rich Plasma (PRP) | Patients will receive an injection of PRP. PRP Ultrasound |
| BG001 | Hyaluronic Acid | Patients will receive an injection of hyaluronic acid. Hyaluronic Acid Ultrasound |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Shoulder Pain and Disability Index (SPADI) Score | Score ranges from 0-100, with a higher score representing higher disability. | Posted | Mean | 95% Confidence Interval | score on a scale | Up to 52 weeks post-procedure |
|
|
Adverse event data were collected over 1 year.
Adverse events included bleeding from the injection site, swelling, infection, allergic reactions, weakness of the muscle surrounding the infected joint. The adverse event percentages noted in this section do not match the ones reported under Outcome Measures, as the Outcome Measures represent the percentage of adverse event cases among all events available (e.g., number of patients * number of follow-up time points).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Platelet-rich Plasma (PRP) | Patients will receive an injection of PRP. PRP Ultrasound |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Weakness of muscle surrounding injection site | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jennifer Cheng | Hospital for Special Surgery | 6467146870 | chengj@hss.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 28, 2021 | Mar 14, 2022 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D020069 | Shoulder Pain |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| ID | Term |
|---|---|
| D006820 | Hyaluronic Acid |
| D014463 | Ultrasonography |
| ID | Term |
|---|---|
| D006025 | Glycosaminoglycans |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
| D003952 | Diagnostic Imaging |
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|
| Ultrasound | Device |
|
| 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". | 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. | Up to 52 weeks post-procedure |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Severe osteoarthritis | Severity of osteoarthritis was determined from radiographs, magnetic resonance imaging, or computed tomography scans by a fellowship-trained musculoskeletal radiologist. Severe osteoarthritis was defined as severe joint space loss with formation of osteophytes (bone spurs). | Count of Participants | Participants |
|
| Counts |
|---|
| Participants |
|
|
| Secondary | 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. | Posted | Mean | 95% Confidence Interval | score on a scale | Up to 52 weeks post-procedure |
|
|
|
| Secondary | 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". | Posted | Count of Participants | Participants | Up to 52 weeks post-procedure |
|
|
|
| Secondary | 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. | Posted | Number | participants | Up to 52 weeks post-procedure |
|
|
|
| 0 |
| 34 |
| 0 |
| 34 |
| 11 |
| 34 |
| EG001 | Hyaluronic Acid | Patients will receive an injection of hyaluronic acid. Hyaluronic Acid Ultrasound | 0 | 35 | 0 | 35 | 13 | 35 |
| Allergic reaction with itchiness | Immune system disorders | Non-systematic Assessment |
|
| Infection | Infections and infestations | Non-systematic Assessment |
|
| Difficulty moving affected shoulder joint | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
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| D018771 |
| Arthralgia |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D019937 |
| Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |