Knee Injuries and DisordersNCT04742868

Recovery of Soccer Players After Anterior Cruciate Ligament Reconstruction.

A study testing ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION WITH QUADRICEPS TENDON WITH BONE GRAFT, ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION WITH HAMSTRING TENDON GRAFT and ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION WITH QUADRICEPS TENDON WITHOUT BONE GRAFT in people with Knee Injuries and Disorders, run by Universidad de Granada at 2 sites in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 16 to 40 years
Conditions the study is for: Knee Injuries and Disorders
What is being tested?: ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION WITH QUADRICEPS TENDON WITH BONE GRAFT, ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION WITH HAMSTRING TENDON GRAFT and ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION WITH QUADRICEPS TENDON WITHOUT BONE GRAFT
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 74 participants
Where: 2 sitesSpain
Study dates: 20 Sep 2020to 1 May 2022
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 16 to 40 years
All sexes
No healthy volunteers
Child, Adult

Who may be able to join

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.

Who cannot join

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.

Trial locations and contacts

2 sites in 1 country.

Spain2 sites

Carolina Fernández Lao
Granada, 18014
Carolina Fernández-Lao
Granada, 18014

Other trials in Spain

About this study

Read the 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.

Conditions: Knee Injuries and Disorders
Being tested: 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
Keywords: ACLR, Quadricepses tendon graft, hamstring tendon graft
Medical subject headings: Knee Injuries, Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION WITH QUADRICEPS TENDON WITH BONE GRAFTProcedure or surgery
Quadriceps tendon with pattlar bone will used for grating
ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION WITH HAMSTRING TENDON GRAFTProcedure or surgery
Hamstring tendon with will used for grating
ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION WITH QUADRICEPS TENDON WITHOUT BONE GRAFTProcedure or surgery
Quadriceps tendon without pattlar bone will used for grating
Rehabilitation protocolOther
All patients will receive six months rehabilitation program which aim to recover the strength and function

Study groups in NCT04742868
Study group	Role	What they receive
Arm 1 QUADRICEPS TENDON WITH BONE GRAFT	Experimental	Quadriceps tendon with bone will be used as graft for the surgery. Receives: Procedure: ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION WITH QUADRICEPS TENDON WITH BONE GRAFT; Other: Rehabilitation protocol
Arm 2 HAMSTRING TENDON GRAFT	Experimental	Hamstring tendon with bone will be used as graft for the surgery Receives: Procedure: ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION WITH HAMSTRING TENDON GRAFT; Other: Rehabilitation protocol
Arm 3. QUADRICEPS TENDON WITHOUT BONE GRAFT	Experimental	Quadriceps tendon without bone will be used as graft for the surgery. Receives: Procedure: ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION WITH QUADRICEPS TENDON WITHOUT BONE GRAFT; Other: Rehabilitation protocol

What is being measured

The primary outcome is the main question the study is designed to answer.

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).
Measured: Patients will be examined before , after 3 , 6 12 and 24 month of the surgery

Secondary outcomes (6)

Visual Analogical Scale
the participants will be completed a visual analogue scale (0-10 points) to assess the presence of knee pain.
Measured: 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.
Measured: 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.
Measured: 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)
Measured: 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
Measured: 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.
Measured: Patients will be examined before , after 3 , 6 12 and 24 month of the surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

20 Sep 20201 May 2022

First posted8 Feb 2021
Study start20 Sep 2020
Primary completion30 Dec 2021
Study completion1 May 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Knee Injuries and DisordersStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Investigator
Enrolment: 74 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04742868
Sponsor's protocol ID: UGranada111
Status last verified: Nov 2022
First submitted: 5 Nov 2020
Last updated: 16 Nov 2022
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Knee Injuries and Disorders trials

Study at a glance

From the registry record, last updated by the sponsor on 16 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Recovery of Soccer Players After Anterior Cruciate Ligament Reconstruction.
ClinicalTrials.gov ID: NCT04742868
Acronym / sponsor ID: UGranada111
Conditions: Knee Injuries and Disorders
Keywords: ACLR, Quadricepses tendon graft, hamstring tendon graft
Study type: Interventional
Recruitment status: Completed
Enrolment: 74 participants (actual)
Lead sponsor: Universidad de GranadaUniversity, hospital or other
Study start: 20 Sep 2020 (actual)
Primary completion: 30 Dec 2021 (actual)
Study completion: 1 May 2022 (actual)
First posted: 8 Feb 2021 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (investigator)
Number of arms: 3

Arm	Type	Receives
Arm 1 QUADRICEPS TENDON WITH BONE GRAFT	Experimental	Procedure: ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION WITH QUADRICEPS TENDON WITH BONE GRAFT, Other: Rehabilitation protocolQuadriceps tendon with bone will be used as graft for the surgery.
Arm 2 HAMSTRING TENDON GRAFT	Experimental	Procedure: ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION WITH HAMSTRING TENDON GRAFT, Other: Rehabilitation protocolHamstring tendon with bone will be used as graft for the surgery
Arm 3. QUADRICEPS TENDON WITHOUT BONE GRAFT	Experimental	Procedure: ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION WITH QUADRICEPS TENDON WITHOUT BONE GRAFT, Other: Rehabilitation protocolQuadriceps tendon without bone will be used as graft for the surgery.

Who may qualify

Ages: 16 to 40 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult

Key inclusion criteria (4 listed)

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.

Key exclusion criteria (4 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION WITH QUADRICEPS TENDON WITH BONE GRAFTQuadriceps tendon with pattlar bone will used for grating	Procedure or surgery	Arm 1 QUADRICEPS TENDON WITH BONE GRAFT
ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION WITH HAMSTRING TENDON GRAFTHamstring tendon with will used for grating	Procedure or surgery	Arm 2 HAMSTRING TENDON GRAFT
ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION WITH QUADRICEPS TENDON WITHOUT BONE GRAFTQuadriceps tendon without pattlar bone will used for grating	Procedure or surgery	Arm 3. QUADRICEPS TENDON WITHOUT BONE GRAFT
Rehabilitation protocolAll patients will receive six months rehabilitation program which aim to recover the strength and function	Other	Arm 1 QUADRICEPS TENDON WITH BONE GRAFT, Arm 2 HAMSTRING TENDON GRAFT, Arm 3. QUADRICEPS TENDON WITHOUT BONE GRAFT

Primary outcome

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).

6 secondary outcomes

Visual Analogical Scale
Time frame: 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
MUSCLE ARQUITECTURE
Time frame: 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
Tegner questionnaire
Time frame: 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

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 Nov 2022.

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Negative Pressure Wound Therapy Devices in Total Knee Arthroplasty
Wound Surgical, Diabetes
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Evaluating Long-term Use of a Pediatric Robotic Exoskeleton (P.REX/Agilik) to Improve Gait in Children With Movement Disorders
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Fernández-Lao principal investigator

Universidad de Granada

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

change of Isokinetic strenght test (time frame: Patients will be examined before , after 3 , 6 12 and 24 month of the surgery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04742868.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Nov 2022.