Recovery of Soccer Players After Anterior Cruciate Ligament Reconstruction.

NCT ID: NCT04742868

Last Updated: 2022-11-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

74 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-09-20

Study Completion Date

2022-05-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Knee Injuries and Disorders

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators
the researcher will evaluate each patient without knowing the type of grafting that will be applied

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Arm 1 QUADRICEPS TENDON WITH BONE GRAFT

Quadriceps tendon with bone will be used as graft for the surgery.

Group Type EXPERIMENTAL

ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION WITH QUADRICEPS TENDON WITH BONE GRAFT

Intervention Type PROCEDURE

Quadriceps tendon with pattlar bone will used for grating

Rehabilitation protocol

Intervention Type OTHER

All patients will receive six months rehabilitation program which aim to recover the strength and function

Arm 2 HAMSTRING TENDON GRAFT

Hamstring tendon with bone will be used as graft for the surgery

Group Type EXPERIMENTAL

ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION WITH HAMSTRING TENDON GRAFT

Intervention Type PROCEDURE

Hamstring tendon with will used for grating

Rehabilitation protocol

Intervention Type OTHER

All patients will receive six months rehabilitation program which aim to recover the strength and function

Arm 3. QUADRICEPS TENDON WITHOUT BONE GRAFT

Quadriceps tendon without bone will be used as graft for the surgery.

Group Type EXPERIMENTAL

ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION WITH QUADRICEPS TENDON WITHOUT BONE GRAFT

Intervention Type PROCEDURE

Quadriceps tendon without pattlar bone will used for grating

Rehabilitation protocol

Intervention Type OTHER

All patients will receive six months rehabilitation program which aim to recover the strength and function

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION WITH QUADRICEPS TENDON WITH BONE GRAFT

Quadriceps tendon with pattlar bone will used for grating

Intervention Type PROCEDURE

ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION WITH HAMSTRING TENDON GRAFT

Hamstring tendon with will used for grating

Intervention Type PROCEDURE

ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION WITH QUADRICEPS TENDON WITHOUT BONE GRAFT

Quadriceps tendon without pattlar bone will used for grating

Intervention Type PROCEDURE

Rehabilitation protocol

All patients will receive six months rehabilitation program which aim to recover the strength and function

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

16 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Universidad de Granada

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Carolina Fernández Lao

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Fernández-Lao

Role: PRINCIPAL_INVESTIGATOR

Universidad de Granada

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Carolina Fernández Lao

Granada, , Spain

Site Status

Carolina Fernández-Lao

Granada, , Spain

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Spain

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

UGranada111

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.