Ignite Creation Date:
2025-12-24 @ 5:53 PM
Ignite Modification Date:
2026-01-09 @ 3:12 PM
Study NCT ID:
NCT04742868
Status:
COMPLETED
Last Update Posted:
2022-11-16
First Post:
2020-11-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Recovery of Soccer Players After Anterior Cruciate Ligament Reconstruction.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007718', 'term': 'Knee Injuries'}, {'id': 'D004194', 'term': 'Disease'}], 'ancestors': [{'id': 'D007869', 'term': 'Leg Injuries'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D059549', 'term': 'Anterior Cruciate Ligament Reconstruction'}, {'id': 'D016025', 'term': 'Bone Transplantation'}], 'ancestors': [{'id': 'D001178', 'term': 'Arthroplasty'}, {'id': 'D019637', 'term': 'Orthopedic Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D019651', 'term': 'Plastic Surgery Procedures'}, {'id': 'D016378', 'term': 'Tissue Transplantation'}, {'id': 'D064987', 'term': 'Cell- and Tissue-Based Therapy'}, {'id': 'D001691', 'term': 'Biological Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D014180', 'term': 'Transplantation'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR'], 'maskingDescription': 'the researcher will evaluate each patient without knowing the type of grafting that will be applied'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 74}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-09-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-11', 'completionDateStruct': {'date': '2022-05-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-11-15', 'studyFirstSubmitDate': '2020-11-05', 'studyFirstSubmitQcDate': '2021-02-02', 'lastUpdatePostDateStruct': {'date': '2022-11-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-02-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Body Mass Index )', 'timeFrame': 'Patients will be examined before , after 3 , 6 12 and 24 month of the surgery', 'description': 'in kg/m2, will be assessed by with bioelectrical impedance analysis (Inbody 720; Biospace, Seoul, South Korea'}, {'measure': 'Fat mass', 'timeFrame': 'Patients will be examined before , after 3 , 6 12 and 24 month of the surgery', 'description': '%fat mass will be assessed by with bioelectrical impedance analysis (Inbody 720; Biospace, Seoul, South Korea)'}, {'measure': 'Lean Mass', 'timeFrame': 'Patients will be examined before , after 3 , 6 12 and 24 month of the surgery', 'description': 'kg of lean mass will be assessed by with bioelectrical impedance analysis (Inbody 720; Biospace, Seoul, South Korea)'}], 'primaryOutcomes': [{'measure': 'change of Isokinetic strenght test', 'timeFrame': 'Patients will be examined before , after 3 , 6 12 and 24 month of the surgery', 'description': 'the assessment will be made with GENU 3 dynamometer (GENU 3, Easytech, Firenze, Italy), using isokinetic parameters at angular velocities of 60°/sec (3 repetitions), 180°/sec (5 repetitions) and 300°/sec (15 repetitions) with 30 seconds of rest among these. To determine the height of the chair, the lateral femoral condyle was aligned with the rotational axis of the dynamometer. The peak torque, average torque and flexor-extensor torque rate value. Patients will be warm up in a cycle ergometer previously (5 min) and them performing mobilization exercises and stretching in lower limbs (5 min).'}], 'secondaryOutcomes': [{'measure': 'Visual Analogical Scale', 'timeFrame': 'Patients will be examined before , after 3 , 6 12 and 24 month of the surgery', 'description': 'the participants will be completed a visual analogue scale (0-10 points) to assess the presence of knee pain.'}, {'measure': 'Pressure Pain Thresholds', 'timeFrame': 'Patients will be examined before , after 3 , 6 12 and 24 month of the surgery', 'description': 'We will use an electronic algometer (Somedic AB, Farsta, Sweden) over 6 points: epicondyle (1), at the midpoint between the greater trochanter and the lateral condyle of the femur on the external (2), at three centimeters above the patella in the vastus medialis (3), at the midpoint between the lower pole of the patella and the anterior tuberosity of the tibia (4), at 3 cm above the patella in midline of the thigh (5) and at the inclusion of the goose leg. The mean of 3 trials will be used for the main analysis.'}, {'measure': 'MUSCLE ARQUITECTURE', 'timeFrame': 'Patients will be examined before , after 3 , 6 12 and 24 month of the surgery', 'description': 'an ultrasound device (MyLab™ 25, Esaote Medical Systems,Genova, Italy) and a 12 MHz linear probe will be used in this study. The depth and width of quad tendon and articular cartilage of femoral trochlea will be captured.'}, {'measure': 'ANTEROPOSTERIOR LAXITY', 'timeFrame': 'Patients will be examined before , after 3 , 6 12 and 24 month of the surgery', 'description': 'it will be measured using the KT-2000 TM arthrometer (MEDmetric, Sn Diego, CA, USA)'}, {'measure': 'Tegner questionnaire', 'timeFrame': 'Patients will be examined before , after 3 , 6 12 and 24 month of the surgery', 'description': 'It is a subjective satisfaction index of on a scale of 0 to 100'}, {'measure': 'Single-legged hop test', 'timeFrame': 'Patients will be examined before , after 3 , 6 12 and 24 month of the surgery', 'description': 'The patient is placed standing on one leg and must jump as far as possible landing on the same leg.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['ACLR', 'Quadricepses tendon graft', 'hamstring tendon graft'], 'conditions': ['Knee Injuries and Disorders']}, 'descriptionModule': {'briefSummary': 'The purpose of this CRT study is to compare clinical and functional outcomes of three graft types ( Quadriceps tendon with bone versus Hamstring tendon versus Quadriceps tendon without bone) for reconstration of anterior cruciate ligament among football players.', 'detailedDescription': 'In the previous studies patellar tendon and hamstring tendon were the most investigated graft types. While quadriceps tendon has been investigated a fewer times. And to our knowledge there is no control study that compare quadriceps tendon-patellar bone autograft with Quadriceps Autograft and Hamstring Autograft as control randomized study.\n\nAll of the patients will be examined before of the surgery and 3, 6, 12, 24 months after the surgery to compare the outcome of differnt graft types. While a secand aim of this study is to examen the effect of rehabilitation protocol on the short and long term within all of the clinical and the functional outcomes.\n\nThe rehabilitation protocol will contain one phase before the surgery and four phases after the surgery.The goal of the first phase will be pain and inflammation control, increase ROM and muscle strength will be during the second and the third phases.In the last phase all of the players have to achieve maximum muscle strength and neuromuscular control.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '40 Years', 'minimumAge': '16 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with ACL injury susceptible to receive a surgical reconstruction.\n* Autograft with Hamstring tendon ,quadriceps tendon or quadriceps tendon with patellar bone.\n* Soccer player for more than 3 years.\n* Between 16 and 40 years old.\n\nExclusion Criteria:\n\n* Patient with previous joint injury.\n* Patient with previous surgery on the affected knee.\n* patient with previous musculoskeletal injury (4 weeks)\n* Patient with untreated chronic injury.'}, 'identificationModule': {'nctId': 'NCT04742868', 'briefTitle': 'Recovery of Soccer Players After Anterior Cruciate Ligament Reconstruction.', 'organization': {'class': 'OTHER', 'fullName': 'Universidad de Granada'}, 'officialTitle': 'Recovery of Soccer Players After Anterior Cruciate Ligament Reconstruction.', 'orgStudyIdInfo': {'id': 'UGranada111'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm 1 QUADRICEPS TENDON WITH BONE GRAFT', 'description': 'Quadriceps tendon with bone will be used as graft for the surgery.', 'interventionNames': ['Procedure: ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION WITH QUADRICEPS TENDON WITH BONE GRAFT', 'Other: Rehabilitation protocol']}, {'type': 'EXPERIMENTAL', 'label': 'Arm 2 HAMSTRING TENDON GRAFT', 'description': 'Hamstring tendon with bone will be used as graft for the surgery', 'interventionNames': ['Procedure: ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION WITH HAMSTRING TENDON GRAFT', 'Other: Rehabilitation protocol']}, {'type': 'EXPERIMENTAL', 'label': 'Arm 3. QUADRICEPS TENDON WITHOUT BONE GRAFT', 'description': 'Quadriceps tendon without bone will be used as graft for the surgery.', 'interventionNames': ['Procedure: ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION WITH QUADRICEPS TENDON WITHOUT BONE GRAFT', 'Other: Rehabilitation protocol']}], 'interventions': [{'name': 'ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION WITH QUADRICEPS TENDON WITH BONE GRAFT', 'type': 'PROCEDURE', 'description': 'Quadriceps tendon with pattlar bone will used for grating', 'armGroupLabels': ['Arm 1 QUADRICEPS TENDON WITH BONE GRAFT']}, {'name': 'ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION WITH HAMSTRING TENDON GRAFT', 'type': 'PROCEDURE', 'description': 'Hamstring tendon with will used for grating', 'armGroupLabels': ['Arm 2 HAMSTRING TENDON GRAFT']}, {'name': 'ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION WITH QUADRICEPS TENDON WITHOUT BONE GRAFT', 'type': 'PROCEDURE', 'description': 'Quadriceps tendon without pattlar bone will used for grating', 'armGroupLabels': ['Arm 3. QUADRICEPS TENDON WITHOUT BONE GRAFT']}, {'name': 'Rehabilitation protocol', 'type': 'OTHER', 'description': 'All patients will receive six months rehabilitation program which aim to recover the strength and function', 'armGroupLabels': ['Arm 1 QUADRICEPS TENDON WITH BONE GRAFT', 'Arm 2 HAMSTRING TENDON GRAFT', 'Arm 3. QUADRICEPS TENDON WITHOUT BONE GRAFT']}]}, 'contactsLocationsModule': {'locations': [{'zip': '18014', 'city': 'Granada', 'country': 'Spain', 'facility': 'Carolina Fernández Lao', 'geoPoint': {'lat': 37.18817, 'lon': -3.60667}}, {'zip': '18014', 'city': 'Granada', 'country': 'Spain', 'facility': 'Carolina Fernández-Lao', 'geoPoint': {'lat': 37.18817, 'lon': -3.60667}}], 'overallOfficials': [{'name': 'Fernández-Lao', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Universidad de Granada'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universidad de Granada', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Carolina Fernández Lao', 'investigatorAffiliation': 'Universidad de Granada'}}}}