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Recovery of Soccer Players After Anterior Cruciate Ligament Reconstruction.

Not Applicable
Completed
Conditions
Knee Injuries and Disorders
Interventions
Procedure: ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION WITH QUADRICEPS TENDON WITHOUT BONE GRAFT
Procedure: ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION WITH QUADRICEPS TENDON WITH BONE GRAFT
Procedure: ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION WITH HAMSTRING TENDON GRAFT
Other: Rehabilitation protocol
Registration Number
NCT04742868
Lead Sponsor
Universidad de Granada
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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
74
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.

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Arm 1 QUADRICEPS TENDON WITH BONE GRAFTRehabilitation protocolQuadriceps tendon with bone will be used as graft for the surgery.
Arm 3. QUADRICEPS TENDON WITHOUT BONE GRAFTANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION WITH QUADRICEPS TENDON WITHOUT BONE GRAFTQuadriceps tendon without bone will be used as graft for the surgery.
Arm 2 HAMSTRING TENDON GRAFTRehabilitation protocolHamstring tendon with bone will be used as graft for the surgery
Arm 1 QUADRICEPS TENDON WITH BONE GRAFTANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION WITH QUADRICEPS TENDON WITH BONE GRAFTQuadriceps tendon with bone will be used as graft for the surgery.
Arm 2 HAMSTRING TENDON GRAFTANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION WITH HAMSTRING TENDON GRAFTHamstring tendon with bone will be used as graft for the surgery
Arm 3. QUADRICEPS TENDON WITHOUT BONE GRAFTRehabilitation protocolQuadriceps tendon without bone will be used as graft for the surgery.
Primary Outcome Measures
NameTimeMethod
change of Isokinetic strenght testPatients will be examined before , after 3 , 6 12 and 24 month of the surgery

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).

Secondary Outcome Measures
NameTimeMethod
Single-legged hop testPatients will be examined before , after 3 , 6 12 and 24 month of the surgery

The patient is placed standing on one leg and must jump as far as possible landing on the same leg.

MUSCLE ARQUITECTUREPatients will be examined before , after 3 , 6 12 and 24 month of the surgery

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.

Pressure Pain ThresholdsPatients will be examined before , after 3 , 6 12 and 24 month of the surgery

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.

Visual Analogical ScalePatients will be examined before , after 3 , 6 12 and 24 month of the surgery

the participants will be completed a visual analogue scale (0-10 points) to assess the presence of knee pain.

ANTEROPOSTERIOR LAXITYPatients will be examined before , after 3 , 6 12 and 24 month of the surgery

it 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 surgery

It is a subjective satisfaction index of on a scale of 0 to 100

Trial Locations

Locations (2)

Carolina Fernández Lao

🇪🇸

Granada, Spain

Carolina Fernández-Lao

🇪🇸

Granada, Spain

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