Recovery of Soccer Players After Anterior Cruciate Ligament Reconstruction.

Knee Injuries and Disorders Clinical Trial

Official title:

Recovery of Soccer Players After Anterior Cruciate Ligament Reconstruction.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04742868
• Other study ID #: UGranada111
• Status: Completed
• Phase: N/A
• Start date: September 20, 2020
• Est. completion date: May 1, 2022

Study information

• Verified date: November 2022
• Source: Universidad de Granada
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 74
• Est. completion date: May 1, 2022
• Est. primary completion date: December 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Knee Injuries
• Knee Injuries and Disorders

Intervention

Procedure:
• ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION WITH QUADRICEPS TENDON WITH BONE GRAFT
Quadriceps tendon with pattlar bone will used for grating
• ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION WITH HAMSTRING TENDON GRAFT
Hamstring tendon with will used for grating
• 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

Locations

Country	Name	City	State
Spain	Carolina Fernández Lao	Granada
Spain	Carolina Fernández-Lao	Granada

Sponsors (1)

Lead Sponsor	Collaborator
Universidad de Granada

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Body Mass Index )	in kg/m2, will be assessed by with bioelectrical impedance analysis (Inbody 720; Biospace, Seoul, South Korea	Patients will be examined before , after 3 , 6 12 and 24 month of the surgery
Other	Fat mass	%fat mass will be assessed by with bioelectrical impedance analysis (Inbody 720; Biospace, Seoul, South Korea)	Patients will be examined before , after 3 , 6 12 and 24 month of the surgery
Other	Lean Mass	kg of lean mass will be assessed by with bioelectrical impedance analysis (Inbody 720; Biospace, Seoul, South Korea)	Patients will be examined before , after 3 , 6 12 and 24 month of the surgery
Primary	change of Isokinetic strenght test	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 examined before , after 3 , 6 12 and 24 month of the surgery
Secondary	Visual Analogical Scale	the participants will be completed a visual analogue scale (0-10 points) to assess the presence of knee pain.	Patients will be examined before , after 3 , 6 12 and 24 month of the surgery
Secondary	Pressure Pain Thresholds	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.	Patients will be examined before , after 3 , 6 12 and 24 month of the surgery
Secondary	MUSCLE ARQUITECTURE	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.	Patients will be examined before , after 3 , 6 12 and 24 month of the surgery
Secondary	ANTEROPOSTERIOR LAXITY	it will be measured using the KT-2000 TM arthrometer (MEDmetric, Sn Diego, CA, USA)	Patients will be examined before , after 3 , 6 12 and 24 month of the surgery
Secondary	Tegner questionnaire	It is a subjective satisfaction index of on a scale of 0 to 100	Patients will be examined before , after 3 , 6 12 and 24 month of the surgery
Secondary	Single-legged hop test	The patient is placed standing on one leg and must jump as far as possible landing on the same leg.	Patients will be examined before , after 3 , 6 12 and 24 month of the surgery