Ignite Creation Date:
2025-12-24 @ 11:40 PM
Ignite Modification Date:
2025-12-25 @ 9:31 PM
Study NCT ID:
NCT04851951
Status:
COMPLETED
Last Update Posted:
2021-04-27
First Post:
2021-04-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Platelet Rich Plasma (PRP) One-Shot Injection For Supraspinatus Tendinosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 48}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-04', 'completionDateStruct': {'date': '2021-04-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-04-23', 'studyFirstSubmitDate': '2021-04-15', 'studyFirstSubmitQcDate': '2021-04-15', 'lastUpdatePostDateStruct': {'date': '2021-04-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-04-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-07-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Visual Analogic Scale', 'timeFrame': 'Day 0; Month 1; Month 3; Month 6 (after the injection)', 'description': 'The shoulder pain was quantified using the Visual Analogic Scale ranging from 0 (no pain) to 10 (worst imaginable pain).'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Supraspinatus tendinosis; PRP; Shoulder;'], 'conditions': ['Supraspinatus Tendinitis']}, 'descriptionModule': {'briefSummary': 'It was conducted a prospective study with a series of 50 patients treated with PRP one-shot injection in patient affected by Supraspinatus Tendinosis. One independent observer performed clinical and functional evaluations at T0 (recruitment), T1 (one month after the injection), T2 (three months after the last injection) and T3 (six months after the last injection).\n\nConstant Score, The Disabilites of the Arm,Shoulder and Hand Score (DASH) And Visual Analogue Scale (VAS) were administered at each evaluation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Fifty (50) patients referring to the Orthopaedic and Trauma Unit of the local University Hospital between January 2018 and July 2020 with Supraspinatus tendinosis were prospectively recruited.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age \\> 18 years old;\n* Supraspinatus tendinosis detected by MRI.\n\nExclusion Criteria:\n\n* Supraspinatus rupture;\n* Previous shoulder surgery;\n* Rotator cuff tears secondary to fracture;\n* Hemoglobin \\<7 g/dL or Platelets \\< 30,000 microL;\n* Active infection;\n* Pregnant patients;\n* Patients with hematologic and oncologic diseases.'}, 'identificationModule': {'nctId': 'NCT04851951', 'briefTitle': 'Platelet Rich Plasma (PRP) One-Shot Injection For Supraspinatus Tendinosis', 'organization': {'class': 'OTHER', 'fullName': 'Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari'}, 'officialTitle': 'Clinical Results Of Platelet Rich Plasma (PRP) One-Shot Injection For Supraspinatus Tendinosis, Our Experience At Short-Term Follow Up', 'orgStudyIdInfo': {'id': 'PRP-shoulder'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'patients treated by one-shot PRP injection', 'interventionNames': ['Procedure: one-shot PRP injection']}], 'interventions': [{'name': 'one-shot PRP injection', 'type': 'PROCEDURE', 'description': 'A single injection of PRP (7% concentrate) ml 4 was made in the Supraspinatus tendon and in the Subacromial space under ultrasound guidance.', 'armGroupLabels': ['patients treated by one-shot PRP injection']}]}, 'contactsLocationsModule': {'locations': [{'zip': '70124', 'city': 'Bari', 'country': 'Italy', 'facility': 'AOUC Policlinico di Bari - UOC Ortopedia e Traumatologia', 'geoPoint': {'lat': 41.12066, 'lon': 16.86982}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}