Ignite Creation Date:
2025-12-25 @ 2:46 AM
Ignite Modification Date:
2026-03-01 @ 3:23 PM
Study NCT ID:
NCT02978833
Status:
TERMINATED
Last Update Posted:
2018-08-07
First Post:
2016-11-29
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Platelet-rich Plasma vs. Whole Blood for Gluteus Medius Tendinopathy
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D052256', 'term': 'Tendinopathy'}], 'ancestors': [{'id': 'D009135', 'term': 'Muscular Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D013708', 'term': 'Tendon Injuries'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014463', 'term': 'Ultrasonography'}], 'ancestors': [{'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'chengj@hss.edu', 'phone': '6467146870', 'title': 'Jennifer Cheng', 'organization': 'Hospital for Special Surgery'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'This study was terminated early. Adverse event data were not collected to completion for each of the patients.', 'eventGroups': [{'id': 'EG000', 'title': 'Platelet-rich Plasma', 'description': 'PRP\n\nUltrasound', 'otherNumAtRisk': 1, 'deathsNumAtRisk': 1, 'otherNumAffected': 0, 'seriousNumAtRisk': 1, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Whole Blood', 'description': 'Whole Blood', 'otherNumAtRisk': 1, 'deathsNumAtRisk': 1, 'otherNumAffected': 0, 'seriousNumAtRisk': 1, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Improvement in Pain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Platelet-rich Plasma', 'description': 'PRP\n\nUltrasound'}, {'id': 'OG001', 'title': 'Whole Blood', 'description': 'Whole Blood'}], 'timeFrame': 'Up to 1 year post-injection', 'description': 'The Numerical Rating Scale for Pain will be used, where 0=no pain and 10=worst pain. A higher number represents more pain.', 'reportingStatus': 'POSTED', 'populationDescription': 'This study was terminated early, and data collection could not be completed. Thus, no data were analyzed.'}, {'type': 'PRIMARY', 'title': 'Improvement in Function', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Platelet-rich Plasma', 'description': 'PRP'}, {'id': 'OG001', 'title': 'Whole Blood', 'description': 'Whole Blood'}], 'timeFrame': 'Up to 1 year post-injection', 'description': 'The Non-Arthritic Hip Score and Veterans RAND 12-Item Health Survey will be used to assess improvement in function.', 'reportingStatus': 'POSTED', 'populationDescription': 'This study was terminated early, and data collection could not be completed. Thus, no data were analyzed.'}, {'type': 'PRIMARY', 'title': 'Patient Satisfaction', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Platelet-rich Plasma', 'description': 'PRP'}, {'id': 'OG001', 'title': 'Whole Blood', 'description': 'Whole Blood'}], 'timeFrame': 'Up to 1 year post-injection', 'description': 'The 10-cm Visual Analog Scale for patient satisfaction will be used. This scale will range from "very dissatisfied" to "extremely satisfied".', 'reportingStatus': 'POSTED', 'populationDescription': 'This study was terminated early, and data collection could not be completed. Thus, no data were analyzed.'}, {'type': 'SECONDARY', 'title': 'Quality of Movement During the Forward Step-down Test', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Platelet-rich Plasma', 'description': 'PRP'}, {'id': 'OG001', 'title': 'Whole Blood', 'description': 'Whole Blood'}], 'timeFrame': 'Up to 1 year post-injection', 'description': 'The quality of movement will be assessed on a scale of 0-4+, where 4+="good", 2-3="moderate", and 0-1="poor".', 'reportingStatus': 'POSTED', 'populationDescription': 'This study was terminated early, and data collection could not be completed. Thus, no data were analyzed.'}, {'type': 'SECONDARY', 'title': 'Pain During Side-lying Hip Abduction', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Platelet-rich Plasma', 'description': 'PRP'}, {'id': 'OG001', 'title': 'Whole Blood', 'description': 'Whole Blood'}], 'timeFrame': 'Up to 1 year post-injection', 'description': 'Pain will be assessed using the 10-cm Visual Analog Scale, which will range from "no pain" to "worst possible pain".', 'reportingStatus': 'POSTED', 'populationDescription': 'This study was terminated early, and data collection could not be completed. Thus, no data were analyzed.'}, {'type': 'SECONDARY', 'title': 'Pain During Forward Step-down Test', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Platelet-rich Plasma', 'description': 'PRP'}, {'id': 'OG001', 'title': 'Whole Blood', 'description': 'Whole Blood'}], 'timeFrame': 'Up to 1 year post-injection', 'description': 'Pain will be assessed using the 10-cm Visual Analog Scale, which will range from "no pain" to "worst possible pain".', 'reportingStatus': 'POSTED', 'populationDescription': 'This study was terminated early, and data collection could not be completed. Thus, no data were analyzed.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Platelet-rich Plasma', 'description': 'PRP\n\nUltrasound'}, {'id': 'FG001', 'title': 'Whole Blood', 'description': 'Whole Blood'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Study terminated', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Platelet-rich Plasma', 'description': 'PRP\n\nUltrasound'}, {'id': 'BG001', 'title': 'Whole Blood', 'description': 'Whole Blood'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-08-06', 'size': 273397, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2018-08-06T10:30', 'hasProtocol': True}, {'date': '2018-08-06', 'size': 140058, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2018-08-06T10:30', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2}}, 'statusModule': {'whyStopped': 'slow enrollment, lack of patients', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2013-10-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-08', 'completionDateStruct': {'date': '2017-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-08-06', 'studyFirstSubmitDate': '2016-11-29', 'resultsFirstSubmitDate': '2018-06-04', 'studyFirstSubmitQcDate': '2016-11-30', 'lastUpdatePostDateStruct': {'date': '2018-08-07', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-08-06', 'studyFirstPostDateStruct': {'date': '2016-12-01', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-08-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Improvement in Pain', 'timeFrame': 'Up to 1 year post-injection', 'description': 'The Numerical Rating Scale for Pain will be used, where 0=no pain and 10=worst pain. A higher number represents more pain.'}, {'measure': 'Improvement in Function', 'timeFrame': 'Up to 1 year post-injection', 'description': 'The Non-Arthritic Hip Score and Veterans RAND 12-Item Health Survey will be used to assess improvement in function.'}, {'measure': 'Patient Satisfaction', 'timeFrame': 'Up to 1 year post-injection', 'description': 'The 10-cm Visual Analog Scale for patient satisfaction will be used. This scale will range from "very dissatisfied" to "extremely satisfied".'}], 'secondaryOutcomes': [{'measure': 'Quality of Movement During the Forward Step-down Test', 'timeFrame': 'Up to 1 year post-injection', 'description': 'The quality of movement will be assessed on a scale of 0-4+, where 4+="good", 2-3="moderate", and 0-1="poor".'}, {'measure': 'Pain During Side-lying Hip Abduction', 'timeFrame': 'Up to 1 year post-injection', 'description': 'Pain will be assessed using the 10-cm Visual Analog Scale, which will range from "no pain" to "worst possible pain".'}, {'measure': 'Pain During Forward Step-down Test', 'timeFrame': 'Up to 1 year post-injection', 'description': 'Pain will be assessed using the 10-cm Visual Analog Scale, which will range from "no pain" to "worst possible pain".'}]}, 'conditionsModule': {'keywords': ['Gluteus Medius Tendinosis'], 'conditions': ['Tendinopathy', 'Hip Pain']}, 'descriptionModule': {'briefSummary': 'Gluteus medius tendinopathy, which is often referred to as Greater Trochanteric Pain Syndrome, is characterized by pain in the lateral aspect of the hip that is aggravated by side lying, stair climbing, and walking. Treatment is currently limited to lifestyle modifications, corticosteroid injections, physical therapy, and open and endoscopic surgical repair. Platelet rich plasma (PRP) injections contain important growth factors that are essential in the healing and tissue formation processes. However, the extent to which PRP is more efficacious than whole blood in tendinopathy remains unclear. In this double-blind randomized trial, patients will be allocated to receive either a PRP or whole-blood injection. Post-procedure assessments will occur at 6 weeks, 3 months, 6 months, 9 months, and 1 year.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '30 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Moderate to severe lateral hip pain for greater than 3 months\n* Symptoms are refractory to conservative treatment, including at least 8 weeks of traditional physical therapy for this condition\n* Moderate to severe gluteus medius tendinosis with or without partial tear \\<1 cm\n* Normal neurologic exam except for hip abductor weakness on the affected side\n\nExclusion Criteria:\n\n* Severe (Tonnis grade \\>1) hip osteoarthritis with active synovitis or bone edema\n* Active lumbar radiculopathy with pain, numbness or weakness in a dermatomal distribution\n* No evidence of fatty atrophy, denervation, or complete tears of gluteus medius seen on MRI\n* Any condition that requires anti-platelet or anti-coagulation therapy, including aspirin therapy for cardiac conditions\n* Non-English speaking'}, 'identificationModule': {'nctId': 'NCT02978833', 'briefTitle': 'Platelet-rich Plasma vs. Whole Blood for Gluteus Medius Tendinopathy', 'organization': {'class': 'OTHER', 'fullName': 'Hospital for Special Surgery, New York'}, 'officialTitle': 'Ultrasound-Guided Platelet Rich Plasma Versus Whole Blood Injection for the Treatment of Gluteus Medius Tendinopathy: A Double-Blind Randomized Controlled Study', 'orgStudyIdInfo': {'id': '2015-184'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'PRP', 'interventionNames': ['Biological: PRP', 'Device: Ultrasound']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Whole Blood', 'interventionNames': ['Biological: Whole Blood']}], 'interventions': [{'name': 'PRP', 'type': 'BIOLOGICAL', 'armGroupLabels': ['PRP']}, {'name': 'Whole Blood', 'type': 'BIOLOGICAL', 'armGroupLabels': ['Whole Blood']}, {'name': 'Ultrasound', 'type': 'DEVICE', 'armGroupLabels': ['PRP']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10021', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Hospital for Special Surgery', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'Peter Moley, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital for Special Surgery, New York'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospital for Special Surgery, New York', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}