search
Back to results

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

Primary Purpose

Acute Injury of Anterior Cruciate Ligament

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
QUADRICEPS TENDON
HAMSTRING TENDON
Sponsored by
Universidad de Granada
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Injury of Anterior Cruciate Ligament focused on measuring ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION, QUADRICEPS TENDON, HAMSTRING TENDON

Eligibility Criteria

12 Years - 40 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Facultad Ciencias de la Salud

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

QUADRICEPS TENDON

HAMSTRING TENDON

Arm Description

ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION USING QUADRICEPS TENDON

ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION USING HAMSTRING TENDON

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Visual Analogical Scale (VAS)
the participants will be completed a visual analogue scale (0-10 points) to assess the presence of knee pain.
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.
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.
ANTEROPOSTERIOR LAXITY
it will be measured using the KT-2000 TM arthrometer (MEDmetric, Sn Diego, CA, USA)
Tegner questionnaire
It is a subjective satisfaction index of on a scale of 0 to 100
Single-legged hop test
The patient is placed standing on one leg and must jump as far as possible landing on the same leg.

Full Information

First Posted
July 6, 2016
Last Updated
January 17, 2018
Sponsor
Universidad de Granada
search

1. Study Identification

Unique Protocol Identification Number
NCT02832791
Brief Title
Comparative Study of Anterior Cruciate Ligament Reconstruction (Quadriceps Versus Hamstring Tendon)
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2018
Overall Recruitment Status
Completed
Study Start Date
July 2015 (Actual)
Primary Completion Date
July 2017 (Actual)
Study Completion Date
July 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad de Granada

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Injury of Anterior Cruciate Ligament
Keywords
ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION, QUADRICEPS TENDON, HAMSTRING TENDON

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
55 (Actual)

8. Arms, Groups, and Interventions

Arm Title
QUADRICEPS TENDON
Arm Type
Active Comparator
Arm Description
ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION USING QUADRICEPS TENDON
Arm Title
HAMSTRING TENDON
Arm Type
Active Comparator
Arm Description
ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION USING HAMSTRING TENDON
Intervention Type
Procedure
Intervention Name(s)
QUADRICEPS TENDON
Other Intervention Name(s)
quadriceps tendon graft
Intervention Description
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
Intervention Type
Procedure
Intervention Name(s)
HAMSTRING TENDON
Other Intervention Name(s)
hamstring tendon graft
Intervention Description
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
Primary Outcome Measure Information:
Title
Isokinetic strenght:
Description
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).
Time Frame
Patients will be followed over 2 years
Secondary Outcome Measure Information:
Title
Visual Analogical Scale (VAS)
Description
the participants will be completed a visual analogue scale (0-10 points) to assess the presence of knee pain.
Time Frame
Patients will be followed over 2 years
Title
Pressure Pain Thresholds:
Description
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.
Time Frame
Patients will be followed over 2 years
Title
MUSCLE ARQUITECTURE
Description
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.
Time Frame
Patients will be followed over 2 years
Title
ANTEROPOSTERIOR LAXITY
Description
it will be measured using the KT-2000 TM arthrometer (MEDmetric, Sn Diego, CA, USA)
Time Frame
Patients will be followed over 2 years
Title
Tegner questionnaire
Description
It is a subjective satisfaction index of on a scale of 0 to 100
Time Frame
Patients will be followed over 2 years
Title
Single-legged hop test
Description
The patient is placed standing on one leg and must jump as far as possible landing on the same leg.
Time Frame
Patients will be followed over 2 years
Other Pre-specified Outcome Measures:
Title
Body Mass Index
Description
in kg/m2, will be assessed by with bioelectrical impedance analysis (Inbody 720; Biospace, Seoul, South Korea)
Time Frame
Patients will be followed over 2 years
Title
Fat mass
Description
%fat mass will be assessed by with bioelectrical impedance analysis (Inbody 720; Biospace, Seoul, South Korea)
Time Frame
Patients will be followed over 2 years
Title
Lean Mass
Description
kg of lean mass will be assessed by with bioelectrical impedance analysis (Inbody 720; Biospace, Seoul, South Korea)
Time Frame
Patients will be followed over 2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jose Luis Martín-Alguacil
Organizational Affiliation
Martín Gómez Clinic from Granada (Spain) and Nutuality of footballers from Andalusian (Spain)
Official's Role
Study Chair
Facility Information:
Facility Name
Facultad Ciencias de la Salud
City
Granada
ZIP/Postal Code
18016
Country
Spain

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs