Ignite Creation Date:
2026-03-26 @ 3:18 PM
Ignite Modification Date:
2026-03-31 @ 2:30 AM
Study NCT ID:
NCT07475351
Status:
RECRUITING
Last Update Posted:
2026-03-23
First Post:
2026-03-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Bone-patellar Tendon-bone and Patellar Tendon-bone Grafts in ACL Reconstruction
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D050376', 'term': 'Bone-Patellar Tendon-Bone Grafting'}], 'ancestors': [{'id': 'D016378', 'term': 'Tissue Transplantation'}, {'id': 'D064987', 'term': 'Cell- and Tissue-Based Therapy'}, {'id': 'D001691', 'term': 'Biological Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D059549', 'term': 'Anterior Cruciate Ligament Reconstruction'}, {'id': 'D001178', 'term': 'Arthroplasty'}, {'id': 'D019637', 'term': 'Orthopedic Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D019651', 'term': 'Plastic Surgery Procedures'}, {'id': 'D014180', 'term': 'Transplantation'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 110}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2026-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2028-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-18', 'studyFirstSubmitDate': '2026-03-11', 'studyFirstSubmitQcDate': '2026-03-11', 'lastUpdatePostDateStruct': {'date': '2026-03-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Donor Site Morbidity', 'timeFrame': 'At 3, 8, 12 and 24 months after surgery', 'description': 'Anterior Cruciate Ligament Donor-site Morbidity Questionnaire will be used to evaluate complications at the harvest site. Scores range from 0 to 100 points, where higher scores indicates better ouctome (absence of donor-site complications).'}], 'secondaryOutcomes': [{'measure': 'Function and activity level', 'timeFrame': 'Baseline (Pre-intervention) and 3, 8, 12 and 24 months after surgery', 'description': 'Lysholm-Tegner score will be used to report knee function and activity level. Scores range from 0 to 100 points, where 100 indicates a better outcome (knee function).'}, {'measure': 'Subjective knee status', 'timeFrame': 'Baseline (Pre-intervention) and 3, 8, 12 and 24 months after surgery', 'description': 'International Knee Documentation Committee (IKDC) will be used to assess knee signs and symptoms. Total scores range from 0 to 100 points, where a higher score indicates a better outcome (absence of symptoms and maximum functional level).'}, {'measure': 'Psychological readiness', 'timeFrame': 'Baseline (Pre-intervention) and 3, 8, 12 and 24 months after surgery', 'description': 'Anterior cruciate ligament - Return to Sport after Injury (ACL-RSI) Scale will be used to evaluate psychological readiness of patients to return to sport after ACL reconstruction. Scores range from 0 to 100 points, where a higher score indicates better outcome (full psychological readiness and confidence).'}, {'measure': 'Joint Awareness', 'timeFrame': 'Baseline (Pre-intervention) and 3, 8, 12 and 24 months after surgery', 'description': 'Forgotten Joint Score (FJS) will be used to assessthe patient\'s ability to forget their affected joint during activities. Scores range from 0 to 100 points, where higher scores indicate a better outcome (patients "forget" the joint, representing a natural feel).'}, {'measure': 'Patient-reported symptoms', 'timeFrame': 'Baseline (Pre-intervention) and 3, 8, 12 and 24 months after surgery', 'description': 'Cincinnati Knee Rating System will be used to ievaluate patient-reported symptoms. scores range from 0 to 100 points, where a higher score (100) indicates better outcome (excellent clinical result, no symptoms, and full return to sports).'}, {'measure': 'Quadriceps strength', 'timeFrame': 'Baseline (Pre-intervention) and 3, 8, 12 and 24 months after surgery', 'description': 'Isokinetic test will be used to evaluate quadriceps peak torque and limb symmetry index. After a warm-up of 10 minutes, patients will perform 5 and 10 unilateral repetitions at 60 and 180º/s respectively, with one minute of rest between series.'}, {'measure': 'Hamstrings strength', 'timeFrame': 'Baseline (Pre-intervention) and 3, 8, 12 and 24 months after surgery', 'description': 'Isokinetic test will be used to evaluate hamstrings peak torque and limb symmetry index. After a warm-up of 10 minutes, patients will perform 5 and 10 unilateral repetitions at 60 and 180º/s respectively, with one minute of rest between series.'}, {'measure': 'Hamstring/Quadriceps ratio', 'timeFrame': 'Baseline (Pre-intervention) and 3, 8, 12 and 24 months after surgery', 'description': 'HQ ratio will be calculated with hamstring and quadriceps peak torque from isokinetic tests.'}, {'measure': 'Functional Hop Test Battery', 'timeFrame': 'Baseline (Pre-intervention) and 8, 12 and 24 months after surgery', 'description': 'A series of four hop tests will be performed to measure dynamic stability and neuromuscular control. Distance and limb symmetry index will be registered.'}, {'measure': 'Donor-site pain pressure threshold', 'timeFrame': 'Baseline (Pre-intervention) and 3, 8, 12 and 24 months after surgery', 'description': 'Pain pressure threshold measured via digital algometry will be used at the patellar tendon.'}, {'measure': 'Quadriceps thickness', 'timeFrame': 'Baseline (Pre-intervention) and 3, 8, 12 and 24 months after surgery', 'description': 'An ultrasound system with a linear probe will be used to measure quadriceps thickness.'}, {'measure': 'Patellar tendon morphology', 'timeFrame': 'Baseline (Pre-intervention) and 3, 8, 12 and 24 months after surgery', 'description': 'An ultrasound system with a linear probe will be used to measure patellar tendon thickness and cross-sectional area.'}, {'measure': 'Anteroposterior knee stability', 'timeFrame': 'Baseline (Pre-intervention) and 3, 8, 12 and 24 months after surgery', 'description': 'A Lachmeter system will be used to evaluate anteroposterior knee stability'}, {'measure': 'Knee stability', 'timeFrame': 'Baseline (Pre-intervention) and 3, 8, 12 and 24 months after surgery', 'description': 'A KIRA system will be used to evaluate anteroposterior and rotational knee stability'}, {'measure': 'Height', 'timeFrame': 'Baseline (Pre-intervention) and 3, 8, 12 and 24 months after surgery', 'description': 'A tallimeter will be used to register height, expressed in meters (m).'}, {'measure': 'Weight', 'timeFrame': 'Baseline (Pre-intervention) and 3, 8, 12 and 24 months after surgery', 'description': 'Bioelectrical impedance analysis (BIA) will be performed by using an Inbody 970 for measuring weight, expressed in kilograms (kg).'}, {'measure': 'Body Mass Index (BMI)', 'timeFrame': 'Baseline (Pre-intervention) and 3, 8, 12 and 24 months after surgery', 'description': 'Bioelectrical impedance analysis (BIA) will be performed by using an Inbody 970 for measuring BMI, expressed in kg/m\\^2.'}, {'measure': 'Percentage of Body Fat', 'timeFrame': 'Baseline (Pre-intervention) and 3, 8, 12 and 24 months after surgery', 'description': 'Bioelectrical impedance analysis (BIA) will be performed by using an Inbody 970 for measuring PBF, expressed in %.'}, {'measure': 'Skeletal Muscle Mass', 'timeFrame': 'Baseline (Pre-intervention) and 3, 8, 12 and 24 months after surgery', 'description': 'Bioelectrical impedance analysis (BIA) will be performed by using an Inbody 970 for measuring SMM, expressed in kg.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION', 'BONE PATELLAR TENDON BONE', 'PATELLAR TENDON'], 'conditions': ['Anterior Cruciate Ligament (ACL) Reconstruction', 'Anterior Cruciate Ligament Injury']}, 'descriptionModule': {'briefSummary': 'The purpose of this randomized study is to compare donor site morbidity and clinical and functional outcomes of both surgery techniques (bone-patellar tendon-bone (BPTB) graft versus bone-patellar tendon without patellar bone plug (PT) graft) for anterior cruciate ligament reconstruction (ACLR) in athletes. The main questions it aims to answer are:\n\n* Does PT graft reduce donor site morbidity compared to the standard BPTB graft?\n* Does PT technique provide clinical and functional results comparable to the BPTB technique? Researchers will compare the incidence of complications and clinical and functional outcomes between the BPTB and PT grafts groups.\n\nPatients will:\n\n* Undergo ACLR surgical intervention using one of the two assigned techniques (BPTB or PT)\n* Follow a two-year assessment program, including visits at three, eight, 12 and 24 months after surgery.', 'detailedDescription': "Anterior cruciate ligament (ACL) rupture is the most prevalent type of knee ligament injury, representing approximately 50% of all reported knee injuries. This injury has a particularly high impact on most athletes due to the demands of pivoting, jumping and cutting movements required during play. In addition, its consequences include a prolonged recovery period, the risk of reinjury and complications arising from ACL insufficiency, such as knee instability, meniscal tears or osteoarthritis. Given that the primary indicator of successful treatment is the athlete's ability to return to competitive levels, surgical reconstruction of the ACL (ACLR) has become the standard treatment. However, the choice of the optimal graft for ACLR remains controversial. For many authors, bone-patellar tendon-bone (BPTB) graft is considered gold-standard option due to optimal biomechanical properties and low reinjury rate. However, BPTB is usually associated with donor site morbidity, specifically related to kneeling, dysesthesia and anterior knee pain.\n\nGiven the disadvantages of the BPTB graft, an ACLR based on a bone-patellar tendon graft may be a viable alternative. This technique utilizes an autograft composed of the central third of the patellar tendon and a tibial tubercle bone plug without inclusion of the patellar bone plug, called bone-patellar tendon (BPT). Previous studies have demonstrated lower rates of anterior knee pain in BPT compared to BPTB. However, there is a lack of evidence regarding objective and specific donor site morbidity assessment for both techniques.\n\nThe main hipothesis of this study is that BPT has similar clinical an functional recovery compared to BPTB with lower rates of anterior knee morbidity."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '40 Years', 'minimumAge': '12 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Time for injury to surgery of less than six months.\n* Active athletes (federated or recreational)\n* Patellar tendon length \\> 42mm measured by MRI.\n* Age between 12 and 40 years old\n* Genders eligible for Study: both\n\nExclusion Criteria:\n\n* Previous surgery or history of ligamentous knee injuries.\n* Concomitant knee ligament injury\n* Major meniscal injury (more than 50% of the lateral or medial meniscus)\n* Chondral injury greater than Outerbridge Grade I-II'}, 'identificationModule': {'nctId': 'NCT07475351', 'briefTitle': 'Comparison of Bone-patellar Tendon-bone and Patellar Tendon-bone Grafts in ACL Reconstruction', 'organization': {'class': 'OTHER', 'fullName': 'Universidad de Granada'}, 'officialTitle': 'Comparison of Morbidity and Functional Outcomes After Anterior Cruciate Ligament Reconstruction With Bone-Tendon-Bone Graft Versus Patellar Tendon Graft Without Patellar Bone Plug in Competitive Athletes', 'orgStudyIdInfo': {'id': 'P36/24/01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Patellar tendon - Bone (PT)', 'interventionNames': ['Procedure: Patellar tendon-Bone']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Bone - Patellar tendon - Bone (BPTB)', 'interventionNames': ['Procedure: Bone-Patellar tendon-Bone']}], 'interventions': [{'name': 'Bone-Patellar tendon-Bone', 'type': 'PROCEDURE', 'description': 'After an arthroscopic examination via an anterolateral viewing portal to confirm the ACL injury, two additional portals will be established: an accessory medial portal slightly above the joint line (approximately 2cm from the medial border of the patellar tendon) and a high anteromedial portal.\n\nOnce associated lesions are addressed, the graft is harvested through a 6cm longitudinal midline incision. Following paratenon dissection, the patellar tendon dimensions are measured:\n\n* Minimum length: 42mm\n* Width-based harvesting: if the tendon width is \\<30mm, a graft consisting of one-third of the total width is harvested. If the width exceeds 30mm, a 10mm wide graft is obtained.\n* Bone plugs: patellar and tibial bone plugs (10x20x8mm) are harvested. While the graft is prepared, anatomic tunnels are created. The graft is secured with MectaScrew (MEDACTA) interference screws. Once fixed, an extra-articular tenodesis is performed using Arnold \\& Coker technique.', 'armGroupLabels': ['Bone - Patellar tendon - Bone (BPTB)']}, {'name': 'Patellar tendon-Bone', 'type': 'PROCEDURE', 'otherNames': ['Patellar tendon'], 'description': 'After an arthroscopic examination via an anterolateral viewing portal to confirm the ACL injury, two additional portals will be established: an accessory medial portal slightly above the joint line (approximately 2cm from the medial border of the patellar tendon) and a high anteromedial portal.\n\nOnce associated lesions are addressed, the graft is harvested through a 6cm longitudinal midline incision. Following paratenon dissection, the patellar tendon dimensions are measured:\n\n* Minimum length: 42mm\n* Width-based harvesting: if the tendon width is \\<30mm, a graft consisting of one-third of the total width is harvested. If the width exceeds 30mm, a 10mm wide graft is obtained.\n* Bone plugs: a tibial bone plug (10x20x8mm) is harvested. While the graft is prepared, anatomic tunnels are created. The graft is secured with MectaScrew (MEDACTA) interference screws. Once fixed, an extra-articular tenodesis is performed using Arnold \\& Coker technique.', 'armGroupLabels': ['Patellar tendon - Bone (PT)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '18016', 'city': 'Granada', 'state': 'Granada', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Jose M Rodriguez-Delgado', 'role': 'CONTACT', 'email': 'josemariard@ugr.es', 'phone': '+34664807986'}, {'name': 'Manuel Arroyo-Morales', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Jose Luis Martin-Alguacil', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Health Sciences Faculty, University of Granada', 'geoPoint': {'lat': 37.18817, 'lon': -3.60667}}], 'centralContacts': [{'name': 'Jose M Rodriguez-Delgado', 'role': 'CONTACT', 'email': 'josemariard@ugr.es', 'phone': '+34664807986'}, {'name': 'Jose Luis Martin-Alguacil', 'role': 'CONTACT', 'email': 'joseluismartinalguacil@hotmail.com', 'phone': '+34666523667'}], 'overallOfficials': [{'name': 'Manuel Arroyo-Morales', 'role': 'STUDY_CHAIR', 'affiliation': 'Universidad de Granada'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universidad de Granada', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MsC, PT', 'investigatorFullName': 'Jose M Rodriguez-Delgado', 'investigatorAffiliation': 'Universidad de Granada'}}}}