Clinical trial NCT02832791: 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
Overall status: COMPLETED
Phase: NA
Conditions: Acute Injury of Anterior Cruciate Ligament
Keywords: ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION
QUADRICEPS TENDON
HAMSTRING TENDON
Lead sponsor: Universidad de Granada
Sponsor class: OTHER
First posted: 2016-07-14
Enrollment: 55
Sex: ALL
Minimum age (years): 12
Maximum age (years): 40
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Isokinetic strenght:
timeFrame: Patients will be followed over 2 years
Secondary outcomes:
measure: Visual Analogical Scale (VAS)
timeFrame: Patients will be followed over 2 years
measure: Pressure Pain Thresholds:
timeFrame: Patients will be followed over 2 years
measure: MUSCLE ARQUITECTURE
timeFrame: Patients will be followed over 2 years
measure: ANTEROPOSTERIOR LAXITY
timeFrame: Patients will be followed over 2 years
measure: Tegner questionnaire
timeFrame: Patients will be followed over 2 years
measure: Single-legged hop test
timeFrame: Patients will be followed over 2 years
Other outcomes:
measure: Body Mass Index
timeFrame: Patients will be followed over 2 years
measure: Fat mass
timeFrame: Patients will be followed over 2 years
measure: Lean Mass
timeFrame: Patients will be followed over 2 years
Locations:
city: Granada
country: Spain
facility: Facultad Ciencias de la Salud
Study officials:
affiliation: Martín Gómez Clinic from Granada (Spain) and Nutuality of footballers from Andalusian (Spain)
name: Jose Luis Martín-Alguacil
role: STUDY_CHAIR
References: