Clinical trial NCT04742868: Recovery of Soccer Players After Anterior Cruciate Ligament Reconstruction.
Official title: Recovery of Soccer Players After Anterior Cruciate Ligament Reconstruction.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Knee Injuries and Disorders
Keywords: ACLR
Quadricepses tendon graft
hamstring tendon graft
Lead sponsor: Universidad de Granada
Sponsor class: OTHER
First posted: 2021-02-08
Enrollment: 74
Sex: ALL
Minimum age (years): 16
Maximum age (years): 40
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: change of Isokinetic strenght test
timeFrame: Patients will be examined before , after 3 , 6 12 and 24 month of the surgery
Secondary outcomes:
measure: Visual Analogical Scale
timeFrame: Patients will be examined before , after 3 , 6 12 and 24 month of the surgery
measure: Pressure Pain Thresholds
timeFrame: Patients will be examined before , after 3 , 6 12 and 24 month of the surgery
measure: MUSCLE ARQUITECTURE
timeFrame: Patients will be examined before , after 3 , 6 12 and 24 month of the surgery
measure: ANTEROPOSTERIOR LAXITY
timeFrame: Patients will be examined before , after 3 , 6 12 and 24 month of the surgery
measure: Tegner questionnaire
timeFrame: Patients will be examined before , after 3 , 6 12 and 24 month of the surgery
measure: Single-legged hop test
timeFrame: Patients will be examined before , after 3 , 6 12 and 24 month of the surgery
Other outcomes:
measure: Body Mass Index )
timeFrame: Patients will be examined before , after 3 , 6 12 and 24 month of the surgery
measure: Fat mass
timeFrame: Patients will be examined before , after 3 , 6 12 and 24 month of the surgery
measure: Lean Mass
timeFrame: Patients will be examined before , after 3 , 6 12 and 24 month of the surgery
Locations:
city: Granada
country: Spain
facility: Carolina Fernández Lao
city: Granada
country: Spain
facility: Carolina Fernández-Lao
Study officials:
affiliation: Universidad de Granada
name: Fernández-Lao
role: PRINCIPAL_INVESTIGATOR
References: