Ignite Creation Date:
2025-12-24 @ 9:46 PM
Ignite Modification Date:
2025-12-27 @ 2:23 AM
Study NCT ID:
NCT05191732
Status:
COMPLETED
Last Update Posted:
2022-01-13
First Post:
2021-09-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of PRP Versus BMC in Anterior Cruciate Ligament Reconstruction
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'To investigate the result of clinical functional scoring, MRI, and biomechanical study between PRP augmentation, PRP+BMC augmentation and traditional ACL reconstruction.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-08-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-09', 'completionDateStruct': {'date': '2020-07-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-01-03', 'studyFirstSubmitDate': '2021-09-30', 'studyFirstSubmitQcDate': '2022-01-03', 'lastUpdatePostDateStruct': {'date': '2022-01-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-01-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-07-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'X-ray', 'timeFrame': 'preoperative', 'description': 'X-ray to evaluate the joint space, graft to bone healing status and graft incorporation.'}, {'measure': 'X-ray', 'timeFrame': '3 months after ACL reconstruction.', 'description': 'X-ray to evaluate the joint space, graft to bone healing status and graft incorporation.'}, {'measure': 'X-ray', 'timeFrame': '6 months after ACL reconstruction.', 'description': 'X-ray to evaluate the joint space, graft to bone healing status and graft incorporation.'}, {'measure': 'X-ray', 'timeFrame': '12 months after ACL reconstruction.', 'description': 'X-ray to evaluate the joint space, graft to bone healing status and graft incorporation.'}, {'measure': 'MRI', 'timeFrame': 'preoperative', 'description': 'MRI to evaluate the joint space, graft to bone healing status and graft incorporation.'}, {'measure': 'MRI of operated knee', 'timeFrame': '3 months after ACL reconstruction.', 'description': 'MRI to evaluate the joint space, graft to bone healing status and graft incorporation.'}, {'measure': 'MRI of operated knee', 'timeFrame': '6 months after ACL reconstruction.', 'description': 'MRI to evaluate the joint space, graft to bone healing status and graft incorporation.'}, {'measure': 'MRI of operated knee', 'timeFrame': '12 months after ACL reconstruction.', 'description': 'MRI to evaluate the joint space, graft to bone healing status and graft incorporation.'}, {'measure': 'Lysholm score', 'timeFrame': 'preoperative', 'description': 'Lysholm score to evaluate the knee function recovery'}, {'measure': 'Lysholm score', 'timeFrame': '3 months after ACL reconstruction.', 'description': 'Lysholm score to evaluate the knee function recovery'}, {'measure': 'Lysholm score', 'timeFrame': '6 months after ACL reconstruction.', 'description': 'Lysholm score to evaluate the knee function recovery'}, {'measure': 'Lysholm score', 'timeFrame': '12 months after ACL reconstruction.', 'description': 'Lysholm score to evaluate the knee function recovery'}, {'measure': 'IKDC 2000', 'timeFrame': 'preoperative', 'description': 'IKDC 2000 to evaluate the knee function recovery'}, {'measure': 'IKDC 2000', 'timeFrame': '3 months after ACL reconstruction.', 'description': 'IKDC 2000 to evaluate the knee function recovery'}, {'measure': 'IKDC 2000', 'timeFrame': '6 months after ACL reconstruction.', 'description': 'IKDC 2000 to evaluate the knee function recovery'}, {'measure': 'IKDC 2000', 'timeFrame': '12 months after ACL reconstruction.', 'description': 'IKDC 2000 to evaluate the knee function recovery'}, {'measure': 'Muscle power (N.m/kg)', 'timeFrame': 'preoperative', 'description': 'muscle power test by Biodex System 3 Pro'}, {'measure': 'Muscle power (N.m/kg)', 'timeFrame': '3 months after ACL reconstruction.', 'description': 'muscle power test by Biodex System 3 Pro'}, {'measure': 'Muscle power (N.m/kg)', 'timeFrame': '6 months after ACL reconstruction.', 'description': 'muscle power test by Biodex System 3 Pro'}, {'measure': 'Muscle power (N.m/kg)', 'timeFrame': '12 months after ACL reconstruction.', 'description': 'muscle power test by Biodex System 3 Pro'}, {'measure': 'Proprioception (degree)', 'timeFrame': 'preoperative', 'description': 'Proprioception test by Biodex System 3 Pro'}, {'measure': 'Proprioception (degree)', 'timeFrame': '3 months after ACL reconstruction.', 'description': 'Proprioception test by Biodex System 3 Pro'}, {'measure': 'Proprioception (degree)', 'timeFrame': '6 months after ACL reconstruction.', 'description': 'Proprioception test by Biodex System 3 Pro'}, {'measure': 'Proprioception (degree)', 'timeFrame': '12 months after ACL reconstruction.', 'description': 'Proprioception test by Biodex System 3 Pro'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Anterior cruciate ligament reconstruction', 'Platelet-Rich Plasma', 'Bone marrow concentrate', 'Hamstring tendon'], 'conditions': ['Anterior Cruciate Ligament Reconstruction']}, 'descriptionModule': {'briefSummary': 'Anterior cruciate ligament (ACL) is an important stabilizer of knee during daily activity and exercise. The ruptured ACL need to be reconstructed by a new tendon graft which passed the bone tunnel and joint during operation. How to enhance the tendon graft to bone tunnel healing is critical important to prevent recurrent ligament laxity, avoid secondary osteoarthritis, and achieve early return to sports and work.\n\nPlatelet Rich Plasma (PRP)，harvest from peripheral blood, is rich in multiple growth factors(i.e. VEGF, PDGD, TGFB, IGF, EGF) which help the injured tissue regeneration. Bone marrow stem cell has been demonstrated to enhance the injured tissue repair both in vitro and in vivo study.\n\nHowever, there is no prospective study in comparing the PRP and BMC to enhance interfacial healing between graft and bone tunnel in ACL reconstruction. Investigators hypothesize that the combination of PRP and BMC has synergetic effect in interfacial healing in ACL reconstruction.\n\nAim of this study： To investigate the result of clinical functional scoring, MRI, and biomechanical study between PRP augmentation, PRP+BMC augmentation and traditional ACL reconstruction.', 'detailedDescription': 'Anterior cruciate ligament (ACL) is an important stabilizer of knee during daily activity and exercise. According to literature, there are 100,000- 200,000 ACL tear case annually in US. The patients with ACL tear will sustain with joint pain, muscle weakness, giving way sensation, other knee ligaments or meniscus injury, and consequent osteoarthritis change. However, the ruptured ACL cannot heal by itself due to limited vascularity supply, intraarticular inflammatory factors which inhibit the ACL cells migration and proliferation. The ruptured ACL need to be reconstructed by a new tendon graft which passed the bone tunnel and joint during operation. How to enhance the tendon graft to bone tunnel healing is critical important to prevent recurrent ligament laxity, avoid secondary osteoarthritis, and achieve early return to sports and work.\n\nPlatelet Rich Plasma (PRP)，harvest from peripheral blood, is rich in multiple growth factors(i.e. VEGF, PDGD, TGFB, IGF, EGF) which help the injured tissue regeneration. The PRP has been applied in treating tendinitis, osteoarthritis, cartilage injury, and bone nonunion. Bone marrow contains lots of stem cell and progenitor cells with capability of self-renewal and multi-differentiation. Bone marrow stem cell has been demonstrated to enhance the injured tissue repair both in vitro and in vivo study. The bone marrow concentrate (BMC) can be isolated from the bone marrow through the centrifuge procedure at one time which contains multiple stem cells. The bone marrow can regenerate itself around 1 week.\n\nIn recent years, many authors uses the combination of RPP and BMC to treat injured tissue. However, there is no prospective study in comparing the PRP and BMC to enhance interfacial healing between graft and bone tunnel in ACL reconstruction. Investigators hypothesize that the combination of PRP and BMC has synergetic effect in interfacial healing in ACL reconstruction.\n\nThe purpose of this study is to investigate the clinical outcome of autologous PRP, and combined BMC+PRP in tendon graft augmentation in the ACL reconstruction surgery with functional score and MRI evaluation. Investigators will analyze the therapeutic effect using one-way ANOVA. To investigate the result of clinical functional scoring, MRI, and biomechanical study between PRP augmentation, PRP+BMC augmentation and traditional ACL reconstruction.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≧ 20 year-old\n* the patient has been confirmed ACL rupture and the reconstruction is indicated\n* sign IRB and operation consent\n\nExclusion Criteria:\n\n* combined other ligament or extremities injury\n* prior the same knee surgery\n* open wound or operation history at knee joint\n* Severe knee osteoarthritis\n* history of multiple joint arthritis or rheumatoid arthritis\n* Systemic diseases (infections, malignancies, immunodepression)\n* patients with bleeding tendency, anticoagulant or antiaggregant therapies\n* patients with Hb values \\< 11 g/dl and/or platelet values \\< 150,000/mm\n* refuse to sign Informed Consent Form and operation consent'}, 'identificationModule': {'nctId': 'NCT05191732', 'briefTitle': 'Effect of PRP Versus BMC in Anterior Cruciate Ligament Reconstruction', 'organization': {'class': 'OTHER', 'fullName': 'Kaohsiung Medical University Chung-Ho Memorial Hospital'}, 'officialTitle': 'The Therapeutic Effect of Autologous Platelet-Rich Plasma Versus Bone Marrow Concentrate in Anterior Cruciate Ligament Reconstruction - A Prospective, Double-Blind Randomized Controlled Study', 'orgStudyIdInfo': {'id': 'KMUHIRB-F(I)-20170122'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'PRP augmentation ACL reconstruction group', 'description': 'Platelet-rich plasma (PRP) (Dosage form: APA-15)', 'interventionNames': ['Combination Product: Platelet-Rich Plasma; Bone marrow concentrate']}, {'type': 'EXPERIMENTAL', 'label': 'PRP+BMC augmentation ACL reconstruction group', 'description': 'Bone marrow concentrate (BMC) (Dosage form: APA-15Q)', 'interventionNames': ['Combination Product: Platelet-Rich Plasma; Bone marrow concentrate']}, {'type': 'NO_INTERVENTION', 'label': 'Traditional ACL reconstruction group', 'description': 'No intervention'}], 'interventions': [{'name': 'Platelet-Rich Plasma; Bone marrow concentrate', 'type': 'COMBINATION_PRODUCT', 'description': 'Platelet-rich plasma (PRP) (Dosage form: APA-15) Bone marrow concentrate (BMC) (Dosage form: APA-15Q)', 'armGroupLabels': ['PRP augmentation ACL reconstruction group', 'PRP+BMC augmentation ACL reconstruction group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '807', 'city': 'Kaohsiung City', 'country': 'Taiwan', 'facility': 'Kaohsiung Medical University Chung-Ho Memorial Hospital', 'geoPoint': {'lat': 22.61626, 'lon': 120.31333}}], 'overallOfficials': [{'name': 'Pei-Hsi Chou, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Kaohsiung Medical University Chung-Ho Memorial Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'There is not a plan to make IPD available.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kaohsiung Medical University Chung-Ho Memorial Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Ministry of Health and Welfare, Taiwan', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'SPONSOR'}}}}