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.

Study Overview

• Status: Completed
• Conditions: Knee Injuries and Disorders
• Intervention / Treatment: Procedure: ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION WITH QUADRICEPS TENDON WITH BONE GRAFT; Other: Rehabilitation protocol; Procedure: ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION WITH HAMSTRING TENDON GRAFT; Procedure: ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION WITH QUADRICEPS TENDON WITHOUT BONE GRAFT

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 Type: Interventional
• Enrollment (Actual): 74
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Granada, Spain, 18014
    • Carolina Fernández Lao
  • Granada, Spain, 18014
    • Carolina Fernández-Lao

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 38 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: Universidad de Granada
• Investigators: Principal Investigator: Fernández-Lao, Universidad de Granada

Study record dates

Study Major Dates

• Study Start (Actual): September 20, 2020
• Primary Completion (Actual): December 30, 2021
• Study Completion (Actual): May 1, 2022

Study Registration Dates

• First Submitted: November 5, 2020
• First Submitted That Met QC Criteria: February 2, 2021
• First Posted (Actual): February 8, 2021

Study Record Updates

• Last Update Posted (Actual): November 16, 2022
• Last Update Submitted That Met QC Criteria: November 15, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: ACLR; Quadricepses tendon graft; hamstring tendon graft
• Additional Relevant MeSH Terms: Wounds and Injuries; Leg Injuries; Knee Injuries
• Other Study ID Numbers: UGranada111

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No