Ignite Creation Date:
2025-12-24 @ 1:04 PM
Ignite Modification Date:
2025-12-28 @ 8:46 PM
Study NCT ID:
NCT04586361
Status:
UNKNOWN
Last Update Posted:
2020-10-14
First Post:
2020-09-13
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Prospective Analysis of Introperative RegenLab PRP and Hyaluronic Acid in Patients With Knee ACL Tear
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D006820', 'term': 'Hyaluronic Acid'}, {'id': 'D000077330', 'term': 'Saline Solution'}], 'ancestors': [{'id': 'D006025', 'term': 'Glycosaminoglycans'}, {'id': 'D011134', 'term': 'Polysaccharides'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D000077324', 'term': 'Crystalloid Solutions'}, {'id': 'D007552', 'term': 'Isotonic Solutions'}, {'id': 'D012996', 'term': 'Solutions'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-10-15', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-10', 'completionDateStruct': {'date': '2022-09-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-10-07', 'studyFirstSubmitDate': '2020-09-13', 'studyFirstSubmitQcDate': '2020-10-07', 'lastUpdatePostDateStruct': {'date': '2020-10-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-10-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-09-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '150 of participants with preoperative and postoperative physical examination are accessed by anterior drawer test and Lachman test', 'timeFrame': 'postoperative 1 month', 'description': 'the investigators recheck physical exmianation of participants at OPD; physical examination was checked by one orthopedist'}, {'measure': '150 of participants with preoperative and postoperative physical examination are accessed by anterior drawer test and Lachman test', 'timeFrame': 'postoperative 3 months', 'description': 'the investigators recheck physical exmianation of participants at OPD; physical examination was checked by one orthopedist'}, {'measure': '150 of participants with preoperative and postoperative physical examination are accessed by anterior drawer test and Lachman test', 'timeFrame': 'postoperative 12 months', 'description': 'the investigators recheck physical exmianation of participants at OPD; physical examination was checked by one orthopedist'}, {'measure': '150 of participants with preoperative and postoperative Magnetic Resonance Imaging are accessed', 'timeFrame': 'postoperative 3 month', 'description': 'anterior cruciate ligament was accessed by MRI T1 and T2 image; MRI was checked by one orthopedist'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['PRP; ACL reconstruction'], 'conditions': ['PRP', 'ACL', 'Hyaluronic Acid']}, 'descriptionModule': {'briefSummary': 'Purpose: The purpose of this article is to examine the clinical application of PRP and PRP+hyaluronic acid in disorders in the knee.\n\nMethods:\n\nThe study was conducted on 150 adult patients with age over 20 years old affected by unilateral ACL complete tear and receiving ACL reconstruction. We divided the patients in three groups, and we treated the group A with perioperative injection of HHA, group B with perioperative HHA+PRP, group C with perioperative normal saline.\n\nFollow-up:\n\nEvery 1,3,and 12months, we recheck physical exmianation at OPD and recheck MRI at postoperative 3 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* receiving unilateral ACL reconstruction in our hospital\n* postoperative follow-up over 3 month\n\nExclusion Criteria:\n\n* postoperative follow-up less than 3 month\n* possible pregnency\n* with coagulation disease\n* NSAIDs intake during study period'}, 'identificationModule': {'nctId': 'NCT04586361', 'briefTitle': 'Prospective Analysis of Introperative RegenLab PRP and Hyaluronic Acid in Patients With Knee ACL Tear', 'organization': {'class': 'OTHER', 'fullName': 'Kaohsiung Veterans General Hospital.'}, 'officialTitle': 'Prospective Analysis of Introperative RegenLab PRP and Hyaluronic Acid in Patients With Knee ACL Tear', 'orgStudyIdInfo': {'id': '200527-2'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental group 1', 'description': 'Intraoperative1 kit of Platelet-rich plasma(PRP) injection into knee joint after anterior cruciate ligament (ACL) reconstruction.', 'interventionNames': ['Combination Product: RegenLab PRP']}, {'type': 'EXPERIMENTAL', 'label': 'Experimental group 2', 'description': 'Intraoperative1 kit of PRP+Hyaluronic acid(HA) injection into knee joint after ACL reconstruction.', 'interventionNames': ['Combination Product: hyaluronic acid']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Experimental group 3', 'description': 'Intraoperative 20 ml normal saline injection into knee joint after ACL reconstruction.', 'interventionNames': ['Other: normal saline']}], 'interventions': [{'name': 'RegenLab PRP', 'type': 'COMBINATION_PRODUCT', 'description': 'PRP preparations also improved functional outcome scores compared to hyaluronic acid and placebo in patients affected by knee osteoarthritis (OA). Based on previous studys, we can conclude that the PRP treatment is a safe and efficacious procedure which can provide functional benefit.', 'armGroupLabels': ['Experimental group 1']}, {'name': 'hyaluronic acid', 'type': 'COMBINATION_PRODUCT', 'otherNames': ['RegenLab PRP'], 'description': 'Few studies investigated the effects of HA+PRP combined treatment for knee osteoarthritis (OA). Numerous studies demonstrated the efficacy of HA injection therapy in knee OA for a clinical point of view, reducing the pain and improving the quality of life.', 'armGroupLabels': ['Experimental group 2']}, {'name': 'normal saline', 'type': 'OTHER', 'description': 'In this study, we compare introperative PRP/PRP+HA/normal saline in ACL reconstruction patient.', 'armGroupLabels': ['Experimental group 3']}]}, 'contactsLocationsModule': {'locations': [{'zip': '813', 'city': 'Kaohsiung City', 'state': 'Kaohsiung', 'status': 'RECRUITING', 'country': 'Taiwan', 'contacts': [{'name': 'Yi Ping Wei, MD', 'role': 'CONTACT', 'email': 'xgoznas22@gmail.com', 'phone': '073422121'}], 'facility': 'Kaohsiung Veterans General Hospital', 'geoPoint': {'lat': 22.61626, 'lon': 120.31333}}], 'centralContacts': [{'name': 'Yi Ping Wei, MD', 'role': 'CONTACT', 'email': 'xgoznas22@gmail.com', 'phone': '+886-7-342-2121'}], 'overallOfficials': [{'name': 'Yi Ping Wei, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Kaohsiung Veterans General Hospital.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kaohsiung Veterans General Hospital.', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Chief resident, Orthopedics department, Kaohsiung Veterans General Hospital; Principal Investigator', 'investigatorFullName': 'Yi Ping Wei', 'investigatorAffiliation': 'Kaohsiung Veterans General Hospital.'}}}}