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Completed

NCT Number: NCT04742868

Recovery of Soccer Players After Anterior Cruciate Ligament Reconstruction.

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.

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Key information

Conditions

Knee Injuries and Disorders Disease Knee Injuries Leg Injuries Pathologic Processes Pathological Conditions, Signs and Symptoms Wounds and Injuries

Age range

16 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Carolina Fernández Lao, Granada, Spain

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION WITH QUADRICEPS TENDON WITH BONE GRAFT

Procedure

Quadriceps tendon with pattlar bone will used for grating

ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION WITH HAMSTRING TENDON GRAFT

Procedure

Hamstring tendon with will used for grating

ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION WITH QUADRICEPS TENDON WITHOUT BONE GRAFT

Procedure

Quadriceps tendon without pattlar bone will used for grating

Rehabilitation protocol

Other

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

Primary outcomes

  1. change of Isokinetic strenght test

    Time frame: Patients 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 outcomes

  1. Visual Analogical Scale

    Time frame: Patients 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.

  2. Pressure Pain Thresholds

    Time frame: Patients 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.

  3. MUSCLE ARQUITECTURE

    Time frame: Patients 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.

  4. ANTEROPOSTERIOR LAXITY

    Time frame: Patients 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)

  5. Tegner questionnaire

    Time frame: Patients 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

  6. Single-legged hop test

    Time frame: Patients 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.

Other outcomes

  1. Body Mass Index )

    Time frame: Patients will be examined before , after 3 , 6 12 and 24 month of the surgery

    in kg/m2, will be assessed by with bioelectrical impedance analysis (Inbody 720; Biospace, Seoul, South Korea

  2. Fat mass

    Time frame: Patients 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)

  3. Lean Mass

    Time frame: Patients will be examined before , after 3 , 6 12 and 24 month of the surgery

    kg of lean mass will be assessed by with bioelectrical impedance analysis (Inbody 720; Biospace, Seoul, South Korea)

Sponsors and collaborators

Lead sponsor

Universidad de Granada

Other

Registry information

Important dates

Study start
2020
Primary completion
2021
Study completion
2022
First posted
Feb 8, 2021
Registry last updated
Nov 16, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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