NCT02832791|Completed
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Sponsor study identifier
interventional
55
1 country
1
Study Start
July 2015
Actual (reported)Primary Completion
July 2017
Actual (reported)Study Completion
July 2017
Actual (reported)The purpose of this randomized study is to compare clinical and functional outcomes of both surgery techniques for anterior cruciate ligament reconstruction (using quadriceps tendon versus hamstring tendon) after reconstruction in athletes.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
July 2017
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
July 2015
Actual (reported)July 6, 2016
Actual (reported)July 14, 2016
Actual (reported)July 2017
Actual (reported)July 2017
Actual (reported)Isokinetic strenght:
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).
Patients will be followed over 2 years
Visual Analogical Scale (VAS)
Patients will be followed over 2 years
Pressure Pain Thresholds:
Patients will be followed over 2 years
MUSCLE ARQUITECTURE
Patients will be followed over 2 years
ANTEROPOSTERIOR LAXITY
Patients will be followed over 2 years
Tegner questionnaire
Patients will be followed over 2 years
Body Mass Index
Patients will be followed over 2 years
Fat mass
Patients will be followed over 2 years
Lean Mass
Patients will be followed over 2 years
ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION USING QUADRICEPS TENDON
ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION USING HAMSTRING TENDON
Once the limb is prepped and draped,it is exsanguinated, and the tourniquet is raised to 250 mm Hg. We will make an arthroscopic examination through an anterolateral viewing portal to corroborate the ACL injury as well as the determination of possible associated lesions. The accessory medial portal is stablished slightly above the joint line (about 2 cm of the medial edge of the patel) that is used as an instrumentation portal. Then,, a high anteromedial portal, is made higher than the previous to see the femoral footprint. Once the associated meniscal or cartilaginous lesions are addressed attention turns to the harvesting of the graft. A 4 cm vertical incision is made starting at the proximal pole of the patella and directed proximally and centered in line with the quadriceps tendon. The subcutaneous tissue is dissected and a 70-80 mm long ,10 mm wide and 7mm depth graft is obtained with the use of a n21 scalpel 2cm of both limbs of the graft are sutured
Facultad Ciencias de la Salud
Granada, 18016, Spain
Jose Luis Martín-Alguacil
Martín Gómez Clinic from Granada (Spain) and Nutuality of footballers from Andalusian (Spain)
55 participants (actual enrollment reported by the registry).
First Submitted
July 6, 2016
First Posted
July 14, 2016
Study Start
July 2015
Actual (reported)Once the limb is prepped and draped,it is exsanguinated, and the tourniquet is raised to 250 mm Hg. The procedure begins with an arthroscopic examination through an anterolateral viewing portal to corroborate the ACL injury as well as the determination of possible associated lesions. The accessory medial portal is stablished slightly above the joint line, at about 2 cm of the medial edge of the patellar tendon. This portal is used as an instrumentation portal. A third portal, a high anteromedial portal, is made higher than the previous, this portal will allow visualization of the femoral footprint. Once the associated meniscal or cartilaginous lesions are addressed attention turns to the harvesting of the graft. A 4cm oblique incision is made starting 2 cm medial to the tibial tubercle and directed proximally and medially. After dissecting the subcutaneous tissue the Sartorius fascia is incised and both tendons are identified and harvested with the use of a tendon stripper
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Primary Completion
July 2017
Actual (reported)Study Completion
July 2017
Actual (reported)Last Updated
January 19, 2018
Record last verified: 2018-01
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Source: ClinicalTrials.gov.
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