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

This study is currently recruiting participants.
Verified October 2016 by Irene Cantarero Villanueva, Universidad de Granada
Sponsor:
ClinicalTrials.gov Identifier:
NCT02832791
First Posted: July 14, 2016
Last Update Posted: October 12, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Irene Cantarero Villanueva, Universidad de Granada
  Purpose
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.

Condition Intervention
Acute Injury of Anterior Cruciate Ligament Procedure: QUADRICEPS TENDON Procedure: HAMSTRING TENDON

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparative Study of Anterior Cruciate Ligament Reconstruction Using Quadriceps Tendon Versus Hamstring Tendon in Postoperative Clinical and Functional State: a Prospective Randomized Controlled Study

Resource links provided by NLM:


Further study details as provided by Irene Cantarero Villanueva, Universidad de Granada:

Primary Outcome Measures:
  • Isokinetic strenght: [ Time Frame: Patients will be followed over 2 years ]
    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).


Secondary Outcome Measures:
  • Visual Analogical Scale (VAS) [ Time Frame: Patients will be followed over 2 years ]
    the participants will be completed a visual analogue scale (0-10 points) to assess the presence of knee pain.

  • Pressure Pain Thresholds: [ Time Frame: Patients will be followed over 2 years ]
    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.

  • MUSCLE ARQUITECTURE [ Time Frame: Patients will be followed over 2 years ]
    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.

  • ANTEROPOSTERIOR LAXITY [ Time Frame: Patients will be followed over 2 years ]
    it will be measured using the KT-2000 TM arthrometer (MEDmetric, Sn Diego, CA, USA)

  • Tegner questionnaire [ Time Frame: Patients will be followed over 2 years ]
    It is a subjective satisfaction index of on a scale of 0 to 100

  • Single-legged hop test [ Time Frame: Patients will be followed over 2 years ]
    The patient is placed standing on one leg and must jump as far as possible landing on the same leg.


Other Outcome Measures:
  • Body Mass Index [ Time Frame: Patients will be followed over 2 years ]
    in kg/m2, will be assessed by with bioelectrical impedance analysis (Inbody 720; Biospace, Seoul, South Korea)

  • Fat mass [ Time Frame: Patients will be followed over 2 years ]
    %fat mass will be assessed by with bioelectrical impedance analysis (Inbody 720; Biospace, Seoul, South Korea)

  • Lean Mass [ Time Frame: Patients will be followed over 2 years ]
    kg of lean mass will be assessed by with bioelectrical impedance analysis (Inbody 720; Biospace, Seoul, South Korea)


Estimated Enrollment: 55
Study Start Date: July 2015
Estimated Study Completion Date: February 2018
Estimated Primary Completion Date: September 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: QUADRICEPS TENDON
ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION USING QUADRICEPS TENDON
Procedure: QUADRICEPS TENDON
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
Other Name: quadriceps tendon graft
Active Comparator: HAMSTRING TENDON
ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION USING HAMSTRING TENDON
Procedure: HAMSTRING TENDON

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

Other Name: hamstring tendon graft

Detailed Description:

Background: The anterior cruciate ligament (ACL) is the most commonly injured ligament of the knee. An ACL-deficient knee can lead to recurrent instability, meniscus tears, and osteoarthritis. Patients treated with an ACL reconstruction (ACLR) have long term success rates of 80 percent to 95 percent. Graft selection may influence outcomes following ACLR. Despite the popularity of the procedure, the preferred graft remains controversial. In the past, bone-patellar tendon-bone grafts have been considered the gold-standard surgical option. However, concerns regarding donor-site morbidity have led to a shift in practice by many surgeons to use quadruple hamstring tendons (HT).Several studies have shown a deficit in the quadriceps and the hamstrings strength after using HT as a graft for ACLR . Recently, there has been an increased interest in the quadriceps tendon as graft option for ACL reconstruction. The benefits of quadriceps tendon autograph include advantageous biomechanical properties, preservation of hamstring anatomy and function, as well as a reduced incidence of donor-site morbidity. To our knowledge there is no randomized controlled trial in the literature comparing QT and HTas autografts for ACLR.

Objective: The purpose of this randomized prospective study is to compare clinical and functional outcomes after using the QT and HT tendons for ACL reconstruction in athletes.

Methods: 55 athletes patients will be recruited from Martín Gómez Clinic from Granada (Spain) and Nutuality of footballers from Andalusian (Spain). Patients will be randomized in two groups: quadriceps tendon versus hamstring tendon. Clinical and functional outcomes will be measured before surgery and three and six months after that. All patients will be operated on by the same senior surgeon and both group will received the same postoperative rehabilitation protocol. Prior to the surgery the participants or their legal representatives must sign the informed consent for participation in this research.

Discussion: The benefits of ACL reconstruction surgery show enough scientific evidence that justifying the emergence of new procedures that improve the outcome of the surgery and the reduction of possible comorbidities. The high prevalence of this disease and the therapeutic success of ACL reconstruction makes that there is an increase of the number of subjects who have received this treatment. However, there is not enough randomized trials that examines the different techniques in terms of clinical and functional outcomes or the risk of comorbidities.

Subjects were placed in the upright position with the hip flexed at 90°. To determine the height of the chair, the lateral femoral condyle was aligned with the rotational axis of the dynamometer. Before each test, the patient was instructed to perform 3 practice repetitions. The highest peak torque value for each velocity was determined, compared to the uninjured side, and described as percent of knee extensor and flexor muscles strength deficits.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years to 40 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02832791


Contacts
Contact: IRENE CANTARERO VILLANUEVA, PhD 637007250 irenecantarero@ugr.es
Contact: Jose Luis Martín-Alguacil 666523667 joseluismartinalguacil@hotmail.com

Locations
Spain
Facultad Ciencias de la Salud Recruiting
Granada, Spain, 18016
Contact: IRENE CANTARERO VILLANUEVA, PhD    637007250      
Contact: Manuel Arroyo Morales, PhD, MD    958248030    marroyo@ugr.es   
Sub-Investigator: Jose Luis Martín Alguacil, MD, MSC         
Sponsors and Collaborators
Universidad de Granada
Investigators
Study Chair: Jose Luis Martín-Alguacil Martín Gómez Clinic from Granada (Spain) and Nutuality of footballers from Andalusian (Spain)
  More Information

Responsible Party: Irene Cantarero Villanueva, PhD, Universidad de Granada
ClinicalTrials.gov Identifier: NCT02832791     History of Changes
Other Study ID Numbers: P16-R13
First Submitted: July 6, 2016
First Posted: July 14, 2016
Last Update Posted: October 12, 2016
Last Verified: October 2016

Keywords provided by Irene Cantarero Villanueva, Universidad de Granada:
ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION
QUADRICEPS TENDON
HAMSTRING TENDON

Additional relevant MeSH terms:
Anterior Cruciate Ligament Injuries
Knee Injuries
Leg Injuries
Wounds and Injuries