Recovery of Soccer Players After Anterior Cruciate Ligament Reconstruction.
Primary Purpose
Knee Injuries and Disorders
Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION WITH QUADRICEPS TENDON WITH BONE GRAFT
ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION WITH HAMSTRING TENDON GRAFT
ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION WITH QUADRICEPS TENDON WITHOUT BONE GRAFT
Rehabilitation protocol
Sponsored by
About this trial
This is an interventional treatment trial for Knee Injuries and Disorders focused on measuring ACLR, Quadricepses tendon graft, hamstring tendon graft
Eligibility 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.
Sites / Locations
- Carolina Fernández Lao
- Carolina Fernández-Lao
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Arm 1 QUADRICEPS TENDON WITH BONE GRAFT
Arm 2 HAMSTRING TENDON GRAFT
Arm 3. QUADRICEPS TENDON WITHOUT BONE GRAFT
Arm Description
Quadriceps tendon with bone will be used as graft for the surgery.
Hamstring tendon with bone will be used as graft for the surgery
Quadriceps tendon without bone will be used as graft for the surgery.
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
Visual Analogical Scale
the participants will be completed a visual analogue scale (0-10 points) to assess the presence of knee pain.
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.
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.
ANTEROPOSTERIOR LAXITY
it will be measured using the KT-2000 TM arthrometer (MEDmetric, Sn Diego, CA, USA)
Tegner questionnaire
It is a subjective satisfaction index of on a scale of 0 to 100
Single-legged hop test
The patient is placed standing on one leg and must jump as far as possible landing on the same leg.
Full Information
NCT ID
NCT04742868
First Posted
November 5, 2020
Last Updated
November 15, 2022
Sponsor
Universidad de Granada
1. Study Identification
Unique Protocol Identification Number
NCT04742868
Brief Title
Recovery of Soccer Players After Anterior Cruciate Ligament Reconstruction.
Official Title
Recovery of Soccer Players After Anterior Cruciate Ligament Reconstruction.
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
September 20, 2020 (Actual)
Primary Completion Date
December 30, 2021 (Actual)
Study Completion Date
May 1, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad de Granada
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Injuries and Disorders
Keywords
ACLR, Quadricepses tendon graft, hamstring tendon graft
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Masking Description
the researcher will evaluate each patient without knowing the type of grafting that will be applied
Allocation
Randomized
Enrollment
74 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Arm 1 QUADRICEPS TENDON WITH BONE GRAFT
Arm Type
Experimental
Arm Description
Quadriceps tendon with bone will be used as graft for the surgery.
Arm Title
Arm 2 HAMSTRING TENDON GRAFT
Arm Type
Experimental
Arm Description
Hamstring tendon with bone will be used as graft for the surgery
Arm Title
Arm 3. QUADRICEPS TENDON WITHOUT BONE GRAFT
Arm Type
Experimental
Arm Description
Quadriceps tendon without bone will be used as graft for the surgery.
Intervention Type
Procedure
Intervention Name(s)
ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION WITH QUADRICEPS TENDON WITH BONE GRAFT
Intervention Description
Quadriceps tendon with pattlar bone will used for grating
Intervention Type
Procedure
Intervention Name(s)
ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION WITH HAMSTRING TENDON GRAFT
Intervention Description
Hamstring tendon with will used for grating
Intervention Type
Procedure
Intervention Name(s)
ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION WITH QUADRICEPS TENDON WITHOUT BONE GRAFT
Intervention Description
Quadriceps tendon without pattlar bone will used for grating
Intervention Type
Other
Intervention Name(s)
Rehabilitation protocol
Intervention Description
All patients will receive six months rehabilitation program which aim to recover the strength and function
Primary Outcome Measure Information:
Title
change of Isokinetic strenght test
Description
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).
Time Frame
Patients will be examined before , after 3 , 6 12 and 24 month of the surgery
Secondary Outcome Measure Information:
Title
Visual Analogical Scale
Description
the participants will be completed a visual analogue scale (0-10 points) to assess the presence of knee pain.
Time Frame
Patients will be examined before , after 3 , 6 12 and 24 month of the surgery
Title
Pressure Pain Thresholds
Description
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.
Time Frame
Patients will be examined before , after 3 , 6 12 and 24 month of the surgery
Title
MUSCLE ARQUITECTURE
Description
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.
Time Frame
Patients will be examined before , after 3 , 6 12 and 24 month of the surgery
Title
ANTEROPOSTERIOR LAXITY
Description
it will be measured using the KT-2000 TM arthrometer (MEDmetric, Sn Diego, CA, USA)
Time Frame
Patients will be examined before , after 3 , 6 12 and 24 month of the surgery
Title
Tegner questionnaire
Description
It is a subjective satisfaction index of on a scale of 0 to 100
Time Frame
Patients will be examined before , after 3 , 6 12 and 24 month of the surgery
Title
Single-legged hop test
Description
The patient is placed standing on one leg and must jump as far as possible landing on the same leg.
Time Frame
Patients will be examined before , after 3 , 6 12 and 24 month of the surgery
Other Pre-specified Outcome Measures:
Title
Body Mass Index )
Description
in kg/m2, will be assessed by with bioelectrical impedance analysis (Inbody 720; Biospace, Seoul, South Korea
Time Frame
Patients will be examined before , after 3 , 6 12 and 24 month of the surgery
Title
Fat mass
Description
%fat mass will be assessed by with bioelectrical impedance analysis (Inbody 720; Biospace, Seoul, South Korea)
Time Frame
Patients will be examined before , after 3 , 6 12 and 24 month of the surgery
Title
Lean Mass
Description
kg of lean mass will be assessed by with bioelectrical impedance analysis (Inbody 720; Biospace, Seoul, South Korea)
Time Frame
Patients will be examined before , after 3 , 6 12 and 24 month of the surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fernández-Lao
Organizational Affiliation
Universidad de Granada
Official's Role
Principal Investigator
Facility Information:
Facility Name
Carolina Fernández Lao
City
Granada
ZIP/Postal Code
18014
Country
Spain
Facility Name
Carolina Fernández-Lao
City
Granada
ZIP/Postal Code
18014
Country
Spain
12. IPD Sharing Statement
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Recovery of Soccer Players After Anterior Cruciate Ligament Reconstruction.
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