Ignite Creation Date:
2025-12-25 @ 1:45 AM
Ignite Modification Date:
2025-12-31 @ 11:36 AM
Study NCT ID:
NCT07088094
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-07-28
First Post:
2025-05-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Clinical Study of Bone-patellar Tendon-bone and Quasi-anatomical Meniscus Allograft Transplantation Technique
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000070598', 'term': 'Anterior Cruciate Ligament Injuries'}], 'ancestors': [{'id': 'D007718', 'term': 'Knee Injuries'}, {'id': 'D007869', 'term': 'Leg Injuries'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2025-05-17', 'size': 1982484, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2025-05-18T11:43', 'hasProtocol': True}, {'date': '2025-03-01', 'size': 248508, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2025-07-17T11:30', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-08-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2028-05-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-17', 'studyFirstSubmitDate': '2025-05-18', 'studyFirstSubmitQcDate': '2025-07-17', 'lastUpdatePostDateStruct': {'date': '2025-07-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-07-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-05-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of Postoperative Complications Unit of Measure', 'timeFrame': '2 years', 'description': 'Unit of Measure: Percentage of patients with complications (e.g., infection, graft failure, arthrofibrosis)\n\nDescription: This measure evaluates the incidence of postoperative complications in patients undergoing bone-patellar tendon-bone and quasi-anatomical meniscus allograft transplantation techniques. The complications will be classified according to the Clavien-Dindo Classification for surgical complications, with clinical evaluations using physical examination and imaging to assess the occurrence of adverse events. The results will be reported as the percentage of patients experiencing any form of complication during the postoperative period.\n\nMeasurement Tool: Clavien-Dindo Classification for surgical complications, clinical evaluation through physical examination, and imaging studies.'}, {'measure': 'Functional Improvement in Knee Joint Unit of Measure-Knee Society Score (KSS)', 'timeFrame': '2 years', 'description': 'Unit of Measure: Improvement in functional scores (0-100 scale)\n\nDescription: This measure evaluates the improvement in knee function following bone-patellar tendon-bone and quasi-anatomical meniscus allograft transplantation techniques. Functional outcomes will be assessed using the Knee Society Score (KSS)\n\nWhat it measures:\n\nKnee Score (0-100): Knee-specific symptoms, alignment, stability. Function Score (0-100): Walking distance, stair-climbing, use of aids. Score Meaning: Higher = Better outcome. Note: Reported as two separate scores (not combined).\n\nMeasurement Tool: Knee Society Score (KSS) and Lysholm Knee Score. The scale use a 0-100 range, where higher scores always indicate better knee function/health.'}, {'measure': 'Functional Improvement in Knee Joint Unit of Measure-Lysholm Knee Score', 'timeFrame': '2 years', 'description': 'Unit of Measure: Improvement in functional scores (0-100 scale)\n\nDescription: This measure evaluates the improvement in knee function following bone-patellar tendon-bone and quasi-anatomical meniscus allograft transplantation techniques. Functional outcomes will be assessed using Lysholm Knee Score.\n\nFull Name: Lysholm Knee Scoring Scale Range: 0-100 What it measures: Stability, pain, daily function. Score Meaning: Higher = Better outcome.\n\nMeasurement Tool: Lysholm Knee Score. The scale use a 0-100 range, where higher scores always indicate better knee function/health.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Meniscal Tears', 'ACL - Anterior Cruciate Ligament Rupture']}, 'referencesModule': {'references': [{'pmid': '22472270', 'type': 'RESULT', 'citation': 'Jiang D, Ao YF, Gong X, Wang YJ, Luo H, Chen LX, Wang HJ, Xie X, Zhang JY, Yu JK. Double-bundle anterior cruciate ligament reconstruction using bone-patellar tendon-bone allograft: technique and 2- to 5-year follow-up. Am J Sports Med. 2012 May;40(5):1084-92. doi: 10.1177/0363546512440686. Epub 2012 Apr 2.'}, {'pmid': '35484433', 'type': 'RESULT', 'citation': 'Wang DY, Lee CA, Zhang B, Li YZ, Meng XY, Jiang D, Yu JK. The immediate meniscal allograft transplantation achieved better chondroprotection and less meniscus degeneration than the conventional delayed transplantation in the long-term. Knee Surg Sports Traumatol Arthrosc. 2022 Nov;30(11):3708-3717. doi: 10.1007/s00167-022-06982-9. Epub 2022 Apr 28.'}]}, 'descriptionModule': {'briefSummary': 'This clinical study investigates the outcomes of bone-patellar tendon-bone and quasi-anatomical meniscus allograft transplantation techniques in patients requiring joint reconstruction. The study aims to assess the safety, efficacy, and functional improvements following these transplant procedures, utilizing donor tissues to restore joint function and alleviate pain in individuals with severe knee damage. Participants will undergo the transplantation procedure and be monitored for post-operative recovery, complications, and long-term outcomes, including joint stability and mobility. The study seeks to provide valuable insights into the effectiveness of these advanced surgical techniques for knee joint repair.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Aged 18-50 years\n* Clinical diagnosis of symptomatic meniscal deficiency and anterior cruciate ligament injury (complete rupture or severe damage)\n* Failure of conservative treatment (e.g., physical therapy, analgesia) for ≥6 months\n* Stable knee joint (no ligamentous instability confirmed via clinical exam and MRI)\n* Willingness to comply with postoperative rehabilitation and follow-up evaluations\n\nExclusion Criteria:\n\n* Severe tibiofemoral osteoarthritis (Kellgren-Lawrence grade ≥3)\n* History of prior knee infection or septic arthritis\n* Inflammatory arthritis (e.g., rheumatoid arthritis, gout)\n* BMI ≥35 kg/m²\n* Pregnancy or planning pregnancy during the study period\n* Concurrent full-thickness chondral defects (Outerbridge grade III-IV) in the affected compartment\n* Inability to undergo MRI (e.g., claustrophobia, metallic implants)'}, 'identificationModule': {'nctId': 'NCT07088094', 'acronym': 'BPTB，Meniscus', 'briefTitle': 'The Clinical Study of Bone-patellar Tendon-bone and Quasi-anatomical Meniscus Allograft Transplantation Technique', 'organization': {'class': 'OTHER', 'fullName': 'Beijing Tsinghua Chang Gung Hospital'}, 'officialTitle': 'The Clinical Study of Bone-patellar Tendon-bone and Quasi-anatomical Meniscus Allograft Transplantation Technique', 'orgStudyIdInfo': {'id': '25076-3-01'}, 'secondaryIdInfos': [{'id': '12110000318301495P', 'type': 'OTHER', 'domain': 'Beijing Tsinghua Changgung Hospital'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Bone-patellar tendon-bone allograft transplantation', 'description': 'Bone-patellar tendon-bone allograft transplantation', 'interventionNames': ['Procedure: bone-patellar tendon-bone or meniscus allograft transplantation techniques']}, {'type': 'NO_INTERVENTION', 'label': 'Control group', 'description': 'non-surgical or conservative treatment group'}, {'type': 'EXPERIMENTAL', 'label': 'Quasi-anatomical meniscus allograft transplantation', 'description': 'Quasi-anatomical meniscus allograft transplantation', 'interventionNames': ['Procedure: Quasi-anatomical meniscus allograft transplantation']}], 'interventions': [{'name': 'bone-patellar tendon-bone or meniscus allograft transplantation techniques', 'type': 'PROCEDURE', 'description': 'This clinical study follows an interventional design, focusing on the evaluation of bone-patellar tendon-bone and quasi-anatomical meniscus allograft transplantation techniques。', 'armGroupLabels': ['Bone-patellar tendon-bone allograft transplantation']}, {'name': 'Quasi-anatomical meniscus allograft transplantation', 'type': 'PROCEDURE', 'description': 'Quasi-anatomical meniscus allograft transplantation', 'armGroupLabels': ['Quasi-anatomical meniscus allograft transplantation']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Beijing Tsinghua Chang Gung Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'YujiakuoTHU', 'investigatorAffiliation': 'Beijing Tsinghua Chang Gung Hospital'}}}}