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Recovery of Soccer Players After Anterior Cruciate Ligament Reconstruction.

Recovery of Soccer Players After Anterior Cruciate Ligament Reconstruction.

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04742868
Enrollment
74
Registered
2021-02-08
Start date
2020-09-20
Completion date
2022-05-01
Last updated
2022-11-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Knee Injuries and Disorders

Keywords

ACLR, Quadricepses tendon graft, hamstring tendon graft

Brief summary

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.

Detailed description

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. All 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. The 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.

Interventions

PROCEDUREANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION WITH QUADRICEPS TENDON WITH BONE GRAFT

Quadriceps tendon with pattlar bone will used for grating

PROCEDUREANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION WITH HAMSTRING TENDON GRAFT

Hamstring tendon with will used for grating

PROCEDUREANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION WITH QUADRICEPS TENDON WITHOUT BONE GRAFT

Quadriceps tendon without pattlar bone will used for grating

All patients will receive six months rehabilitation program which aim to recover the strength and function

Sponsors

Universidad de Granada
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)

Masking description

the researcher will evaluate each patient without knowing the type of grafting that will be applied

Eligibility

Sex/Gender
ALL
Age
16 Years to 40 Years
Healthy volunteers
No

Inclusion criteria

* Patients with ACL injury susceptible to receive a surgical reconstruction. * Autograft with Hamstring tendon ,quadriceps tendon or quadriceps tendon with patellar bone. * Soccer player for more than 3 years. * Between 16 and 40 years old.

Exclusion criteria

* Patient with previous joint injury. * Patient with previous surgery on the affected knee. * patient with previous musculoskeletal injury (4 weeks) * Patient with untreated chronic injury.

Design outcomes

Primary

MeasureTime frameDescription
change of Isokinetic strenght testPatients will be examined before , after 3 , 6 12 and 24 month of the surgerythe 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).

Secondary

MeasureTime frameDescription
MUSCLE ARQUITECTUREPatients will be examined before , after 3 , 6 12 and 24 month of the surgeryan 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.
ANTEROPOSTERIOR LAXITYPatients will be examined before , after 3 , 6 12 and 24 month of the surgeryit will be measured using the KT-2000 TM arthrometer (MEDmetric, Sn Diego, CA, USA)
Tegner questionnairePatients will be examined before , after 3 , 6 12 and 24 month of the surgeryIt is a subjective satisfaction index of on a scale of 0 to 100
Single-legged hop testPatients will be examined before , after 3 , 6 12 and 24 month of the surgeryThe patient is placed standing on one leg and must jump as far as possible landing on the same leg.
Visual Analogical ScalePatients will be examined before , after 3 , 6 12 and 24 month of the surgerythe participants will be completed a visual analogue scale (0-10 points) to assess the presence of knee pain.
Pressure Pain ThresholdsPatients will be examined before , after 3 , 6 12 and 24 month of the surgeryWe 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.

Other

MeasureTime frameDescription
Lean MassPatients will be examined before , after 3 , 6 12 and 24 month of the surgerykg of lean mass will be assessed by with bioelectrical impedance analysis (Inbody 720; Biospace, Seoul, South Korea)
Body Mass Index )Patients will be examined before , after 3 , 6 12 and 24 month of the surgeryin kg/m2, will be assessed by with bioelectrical impedance analysis (Inbody 720; Biospace, Seoul, South Korea
Fat massPatients will be examined before , after 3 , 6 12 and 24 month of the surgery%fat mass will be assessed by with bioelectrical impedance analysis (Inbody 720; Biospace, Seoul, South Korea)

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026