Recovery of Soccer Players After Anterior Cruciate Ligament Reconstruction.

November 15, 2022 updated by: Carolina Fernández Lao, Universidad de Granada
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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
74

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

12 years to 36 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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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).
Patients will be examined before , after 3 , 6 12 and 24 month of the surgery

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
Patients will be examined before , after 3 , 6 12 and 24 month of the surgery
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.
Patients will be examined before , after 3 , 6 12 and 24 month of the surgery
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.
Patients will be examined before , after 3 , 6 12 and 24 month of the surgery
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)
Patients will be examined before , after 3 , 6 12 and 24 month of the surgery
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
Patients will be examined before , after 3 , 6 12 and 24 month of the surgery
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.
Patients will be examined before , after 3 , 6 12 and 24 month of the surgery

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
Patients will be examined before , after 3 , 6 12 and 24 month of the surgery
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)
Patients will be examined before , after 3 , 6 12 and 24 month of the surgery
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)
Patients will be examined before , after 3 , 6 12 and 24 month of the surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Universidad de Granada

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Fernández-Lao, Universidad de Granada

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 20, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 30, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 5, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 2, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 8, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 16, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 15, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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