Recovery of Soccer Players After Anterior Cruciate Ligament Reconstruction.

NCT04742868 | Completed

• 1 other identifier: UGranada111
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 2

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.

Conditions

Knee Injuries and Disorders

Keywords

ACLR; Quadricepses tendon graft; hamstring tendon graft

Outcome Measures

Primary Outcomes (1)

• 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).

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

Secondary Outcomes (6)

• Visual Analogical Scale

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

• Pressure Pain Thresholds

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

• MUSCLE ARQUITECTURE

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

• ANTEROPOSTERIOR LAXITY

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

• Tegner questionnaire

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

Other Outcomes (3)

• Body Mass Index )

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

• Fat mass

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

• Lean Mass

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

Study Arms (3)

Arm 1 QUADRICEPS TENDON WITH BONE GRAFT

EXPERIMENTAL

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

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

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.

Procedure: ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION WITH QUADRICEPS TENDON WITHOUT BONE GRAFT; Other: Rehabilitation protocol

Interventions

ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION WITH QUADRICEPS TENDON WITH BONE GRAFT PROCEDURE

Quadriceps tendon with pattlar bone will used for grating

Arm 1 QUADRICEPS TENDON WITH BONE GRAFT

ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION WITH HAMSTRING TENDON GRAFT PROCEDURE

Hamstring tendon with will used for grating

Arm 2 HAMSTRING TENDON GRAFT

ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION WITH QUADRICEPS TENDON WITHOUT BONE GRAFT PROCEDURE

Quadriceps tendon without pattlar bone will used for grating

Arm 3. QUADRICEPS TENDON WITHOUT BONE GRAFT

Rehabilitation protocol OTHER

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

Arm 1 QUADRICEPS TENDON WITH BONE GRAFT; Arm 2 HAMSTRING TENDON GRAFT; Arm 3. QUADRICEPS TENDON WITHOUT BONE GRAFT

Eligibility Criteria

• Age: 16 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidad de Granada: lead

Study Sites (2)

Carolina Fernández Lao

Granada, 18014, Spain

Location

Carolina Fernández-Lao

Granada, 18014, Spain

Location

MeSH Terms

Conditions

Knee Injuries; Disease

Interventions

Anterior Cruciate Ligament Reconstruction; Bone Transplantation

Condition Hierarchy (Ancestors)

Leg Injuries; Wounds and Injuries; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Arthroplasty; Orthopedic Procedures; Surgical Procedures, Operative; Plastic Surgery Procedures; Tissue Transplantation; Cell- and Tissue-Based Therapy; Biological Therapy; Therapeutics; Transplantation

Study Officials

• Fernández-Lao

  Universidad de Granada

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: the researcher will evaluate each patient without knowing the type of grafting that will be applied
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 5, 2020
• First Posted: February 8, 2021
• Study Start: September 20, 2020
• Primary Completion: December 30, 2021
• Study Completion: May 1, 2022
• Last Updated: November 16, 2022

Record last verified: 2022-11

Locations

ES (2)