Comparative Study of Anterior Cruciate Ligament Reconstruction (Quadriceps Versus Hamstring Tendon)

NCT02832791 | Completed

• 1 other identifier: P16-R13
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this randomized study is to compare clinical and functional outcomes of both surgery techniques for anterior cruciate ligament reconstruction (using quadriceps tendon versus hamstring tendon) after reconstruction in athletes.

Conditions

Acute Injury of Anterior Cruciate Ligament

Keywords

ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION; QUADRICEPS TENDON; HAMSTRING TENDON

Outcome Measures

Primary Outcomes (1)

• Isokinetic strenght:

  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 followed over 2 years

Secondary Outcomes (6)

• Visual Analogical Scale (VAS)

  Patients will be followed over 2 years

• Pressure Pain Thresholds:

  Patients will be followed over 2 years

• MUSCLE ARQUITECTURE

  Patients will be followed over 2 years

• ANTEROPOSTERIOR LAXITY

  Patients will be followed over 2 years

• Tegner questionnaire

  Patients will be followed over 2 years

Other Outcomes (3)

• Body Mass Index

  Patients will be followed over 2 years

• Fat mass

  Patients will be followed over 2 years

• Lean Mass

  Patients will be followed over 2 years

Study Arms (2)

QUADRICEPS TENDON

ACTIVE COMPARATOR

ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION USING QUADRICEPS TENDON

Procedure: QUADRICEPS TENDON

HAMSTRING TENDON

ACTIVE COMPARATOR

ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION USING HAMSTRING TENDON

Procedure: HAMSTRING TENDON

Interventions

QUADRICEPS TENDON PROCEDURE

Once the limb is prepped and draped,it is exsanguinated, and the tourniquet is raised to 250 mm Hg. We will make an arthroscopic examination through an anterolateral viewing portal to corroborate the ACL injury as well as the determination of possible associated lesions. The accessory medial portal is stablished slightly above the joint line (about 2 cm of the medial edge of the patel) that is used as an instrumentation portal. Then,, a high anteromedial portal, is made higher than the previous to see the femoral footprint. Once the associated meniscal or cartilaginous lesions are addressed attention turns to the harvesting of the graft. A 4 cm vertical incision is made starting at the proximal pole of the patella and directed proximally and centered in line with the quadriceps tendon. The subcutaneous tissue is dissected and a 70-80 mm long ,10 mm wide and 7mm depth graft is obtained with the use of a n21 scalpel 2cm of both limbs of the graft are sutured

Also known as: quadriceps tendon graft

QUADRICEPS TENDON

HAMSTRING TENDON PROCEDURE

Once the limb is prepped and draped,it is exsanguinated, and the tourniquet is raised to 250 mm Hg. The procedure begins with an arthroscopic examination through an anterolateral viewing portal to corroborate the ACL injury as well as the determination of possible associated lesions. The accessory medial portal is stablished slightly above the joint line, at about 2 cm of the medial edge of the patellar tendon. This portal is used as an instrumentation portal. A third portal, a high anteromedial portal, is made higher than the previous, this portal will allow visualization of the femoral footprint. Once the associated meniscal or cartilaginous lesions are addressed attention turns to the harvesting of the graft. A 4cm oblique incision is made starting 2 cm medial to the tibial tubercle and directed proximally and medially. After dissecting the subcutaneous tissue the Sartorius fascia is incised and both tendons are identified and harvested with the use of a tendon stripper

Also known as: hamstring tendon graft

HAMSTRING TENDON

Eligibility Criteria

• Age: 12 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Ages: \< 40 years old
• Genders eligible for Study: both

You may not qualify if:

• LCA injury diagnosis base on clinical and radiographic features with less than 6 months of evolution of the lesion at diagnosis time.
• Recreational or federated athletes

Sponsors & Collaborators

• Universidad de Granada: lead

Study Sites (1)

Facultad Ciencias de la Salud

Granada, 18016, Spain

Location

Study Officials

• Jose Luis Martín-Alguacil

  Martín Gómez Clinic from Granada (Spain) and Nutuality of footballers from Andalusian (Spain)

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: July 6, 2016
• First Posted: July 14, 2016
• Study Start: July 1, 2015
• Primary Completion: July 1, 2017
• Study Completion: July 1, 2017
• Last Updated: January 19, 2018

Record last verified: 2018-01

Locations

ES (1)