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Recovery of Soccer Players After Anterior Cruciate Ligament Reconstruction.

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ClinicalTrials.gov Identifier: NCT04742868
Recruitment Status : Recruiting
First Posted : February 8, 2021
Last Update Posted : February 8, 2021
Sponsor:
Information provided by (Responsible Party):
Carolina Fernández Lao, Universidad de Granada

Study Description
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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.

Condition or disease Intervention/treatment Phase
Knee Injuries and Disorders Procedure: ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION WITH QUADRICEPS TENDON WITH BONE GRAFT Procedure: ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION WITH HAMSTRING TENDON GRAFT Procedure: ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION WITH QUADRICEPS TENDON WITHOUT BONE GRAFT Other: Rehabilitation protocol Not Applicable

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 84 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Masking Description: the researcher will evaluate each patient without knowing the type of grafting that will be applied
Primary Purpose: Treatment
Official Title: Recovery of Soccer Players After Anterior Cruciate Ligament Reconstruction.
Actual Study Start Date : September 20, 2020
Estimated Primary Completion Date : September 30, 2021
Estimated Study Completion Date : March 1, 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Arm 1 QUADRICEPS TENDON WITH BONE GRAFT
Quadriceps tendon with bone will be used as graft for the surgery.
 Procedure: ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION WITH QUADRICEPS TENDON WITH BONE GRAFT
Quadriceps tendon with pattlar bone will used for grating

Other: Rehabilitation protocol
All patients will receive six months rehabilitation program which aim to recover the strength and function
Experimental: Arm 2 HAMSTRING TENDON GRAFT
Hamstring tendon with bone will be used as graft for the surgery
 Procedure: ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION WITH HAMSTRING TENDON GRAFT
Hamstring tendon with will used for grating

Other: Rehabilitation protocol
All patients will receive six months rehabilitation program which aim to recover the strength and function
Experimental: Arm 3. QUADRICEPS TENDON WITHOUT BONE GRAFT
Quadriceps tendon without bone will be used as graft for the surgery.
 Procedure: ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION WITH QUADRICEPS TENDON WITHOUT BONE GRAFT
Quadriceps tendon without pattlar bone will used for grating

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


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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)


Eligibility Criteria
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Ages Eligible for Study:   16 Years to 40 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04742868


Locations
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Spain
Carolina Fernández Lao Recruiting
Granada, Spain, 18014
Contact: Carolina Fernández Lao, PhD    0034665879315    carolinafl@ugr.es   
Sub-Investigator: Fahed Herbawi, MsC         
Sub-Investigator: Mario Lozano Lozano, PhD         
Sponsors and Collaborators
Universidad de Granada
More Information
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Responsible Party: Carolina Fernández Lao, Principal Investigator, Universidad de Granada
ClinicalTrials.gov Identifier: NCT04742868    
Other Study ID Numbers: UGranada111
First Posted: February 8, 2021    Key Record Dates
Last Update Posted: February 8, 2021
Last Verified: February 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Carolina Fernández Lao, Universidad de Granada:
ACLR
Quadricepses tendon graft
hamstring tendon graft
Additional relevant MeSH terms:
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Knee Injuries
Leg Injuries
Wounds and Injuries