Ignite Creation Date:
2025-12-25 @ 5:12 AM
Ignite Modification Date:
2025-12-26 @ 4:17 AM
Study NCT ID:
NCT05675527
Status:
RECRUITING
Last Update Posted:
2025-10-06
First Post:
2022-12-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
PRP for Glenohumeral Osteoarthritis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D012965', 'term': 'Sodium Chloride'}], 'ancestors': [{'id': 'D002712', 'term': 'Chlorides'}, {'id': 'D006851', 'term': 'Hydrochloric Acid'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017670', 'term': 'Sodium Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 135}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-05-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2026-09-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-10-01', 'studyFirstSubmitDate': '2022-12-28', 'studyFirstSubmitQcDate': '2022-12-28', 'lastUpdatePostDateStruct': {'date': '2025-10-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2023-01-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-09-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'American Shoulder and Elbow Surgeons (ASES) Shoulder Score', 'timeFrame': '3 months post-injection', 'description': 'The ASES measures pain and function in activities of daily living related to the shoulder. On a 100-point scale, a higher score represents less pain/higher function.'}], 'secondaryOutcomes': [{'measure': 'Average numerical rating scale (NRS) pain score', 'timeFrame': 'Up to 12 months post-injection', 'description': 'Average NRS pain during the past week. This is on a scale of 0-10, with 0 representing no pain and 10 representing the worst pain possible.'}, {'measure': 'Patient-Reported Outcomes Measurement Information System (PROMIS)-10 Global Health measure', 'timeFrame': 'Up to 12 months post-injection', 'description': 'The PROMIS-10 assesses physical health and mental health. A higher score represents better physical health and mental health.'}, {'measure': 'PROMIS-Upper Extremity computer adaptive test (CAT)', 'timeFrame': 'Up to 12 months post-injection', 'description': 'The PROMIS-Upper Extremity CAT measures upper extremity (shoulder) function. A higher scores represents better function.'}, {'measure': 'Medication use', 'timeFrame': 'Up to 12 months post-injection', 'description': 'Patients will be asked if they are using any of the following medications: non-steroidal anti-inflammatory drugs, opioids, selective serotonin reuptake inhibitors, or neuropathic medications.'}, {'measure': 'PROMIS Sleep Disturbance', 'timeFrame': 'Up to 12 months post-injection', 'description': 'The PROMIS sleep disturbance measures sleep impairment/disturbance. A higher score represents more sleep disturbance (e.g., worse sleep quality).'}, {'measure': 'Patient satisfaction', 'timeFrame': 'Up to 12 months post-injection', 'description': 'Patient satisfaction is assessed on a 0-10 scale, with 0 meaning "not satisfied at all" and 10 meaning "very satisfied".'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Shoulder Osteoarthritis']}, 'descriptionModule': {'briefSummary': 'The glenohumeral joint is the third most common large joint to be affected by OA. Conservative treatments include physical activity, corticosteroid injections, and medications. PRP is an emerging treatment that has shown efficacy in different musculoskeletal conditions. The use of PRP for glenohumeral OA has been described sparingly in the literature but has shown efficacy in a couple studies and case reports. However, all of the previous studies investigating PRP for glenohumeral OA have focused on low-dose PRP preparations (\\~3X), and none have compared PRP treatment to saline treatment. This study aims to compare outcomes following single injections of low-dose PRP, high-dose PRP, or saline in patients with glenohumeral osteoarthritis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18-100 years old\n* Average NRS pain greater than or equal to 5/10 as a direct result of glenohumeral osteoarthritis (any severity: mild, moderate, or severe) and/or chondral lesion or loss\n* At least 3 months of pain after onset of symptoms that has failed conservative treatments, including physical therapy\n* MRI of the affected joint\n* Transient relief of symptoms after a diagnostic intra-articular injection into the joint\n* Email address or network access\n\nExclusion Criteria:\n\n* Inability to hold non-steroidal anti-inflammatory drugs for 2 weeks prior and 1 month after the injection\n* Prior platelet-rich plasma injection\n* Steroid injection within 3 months of the initial injection\n* Hyaluronic acid within 6 months of the initial injection\n* Involved in workers\' compensation or active litigation involving the affected joint\n* History of Plavix use\n* Known uncontrolled systemic illness (uncontrolled diabetes, HIV, vasculitis, autoimmune/autoinflammatory disease)\n* Presence of acute fractures or gross mechanical deformities\n* Concurrent "uncontrolled" cervical disorders'}, 'identificationModule': {'nctId': 'NCT05675527', 'briefTitle': 'PRP for Glenohumeral Osteoarthritis', 'organization': {'class': 'OTHER', 'fullName': 'Hospital for Special Surgery, New York'}, 'officialTitle': 'Outcomes Following Single Injections of Low-dose Platelet-rich Plasma (PRP), High-dose PRP, or Saline in Patients With Glenohumeral OA: a Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '2022-0720'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Low-dose PRP', 'description': 'Patients will receive a single injection of 6 ml low-dose platelet-rich plasma (PRP) into the glenohumeral joint. Low-dose is defined as a platelet yield of 3X (i.e., 3-fold increase in platelets in PRP compared to whole blood).', 'interventionNames': ['Biological: Low-dose PRP']}, {'type': 'EXPERIMENTAL', 'label': 'High-dose PRP', 'description': 'Patients will receive a single injection of 6 ml high-dose platelet-rich plasma (PRP) into the glenohumeral joint. High-dose is defined as a platelet yield of 12X (i.e., 12-fold increase in platelets in PRP compared to whole blood).', 'interventionNames': ['Biological: High-dose PRP']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Saline control', 'description': 'Patients will receive a single injection of 6 ml saline into the glenohumeral joint.', 'interventionNames': ['Other: Saline']}], 'interventions': [{'name': 'Low-dose PRP', 'type': 'BIOLOGICAL', 'description': 'Injection', 'armGroupLabels': ['Low-dose PRP']}, {'name': 'High-dose PRP', 'type': 'BIOLOGICAL', 'description': 'Injection', 'armGroupLabels': ['High-dose PRP']}, {'name': 'Saline', 'type': 'OTHER', 'description': 'Injection', 'armGroupLabels': ['Saline control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10021', 'city': 'New York', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Jonathan Kirschner, MD', 'role': 'CONTACT', 'email': 'kirschnerj@hss.edu'}], 'facility': 'Hospital for Special Surgery', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'centralContacts': [{'name': 'Jonathan Kirschner, MD', 'role': 'CONTACT', 'email': 'kirschnerj@hss.edu', 'phone': '646-714-6327'}, {'name': 'Jennifer Cheng', 'role': 'CONTACT', 'email': 'chengj@hss.edu', 'phone': '646-714-6870'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospital for Special Surgery, New York', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}