Comparative Study of Anterior Cruciate Ligament Reconstruction Using Quadriceps Tendon Versus Hamstring Tendon in Postoperative Clinical and Functional State: a Prospective Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 55
- 试验地点
- 2
- 主要终点
- Isokinetic strenght:
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 12 Years 至 40 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ages: < 40 years old
- •Genders eligible for Study: both
排除标准
- •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
研究组 & 干预措施
QUADRICEPS TENDON
ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION USING QUADRICEPS TENDON
干预措施: QUADRICEPS TENDON (Procedure)
HAMSTRING TENDON
ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION USING HAMSTRING TENDON
干预措施: HAMSTRING TENDON (Procedure)
结局指标
主要结局
Isokinetic strenght:
时间窗: 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).
次要结局
- Visual Analogical Scale (VAS)(Patients will be followed over 2 years)
- Tegner questionnaire(Patients will be followed over 2 years)
- Single-legged hop test(Patients will be followed over 2 years)
- ANTEROPOSTERIOR LAXITY(Patients will be followed over 2 years)
- MUSCLE ARQUITECTURE(Patients will be followed over 2 years)
- Pressure Pain Thresholds:(Patients will be followed over 2 years)
研究者
Irene Cantarero Villanueva
PhD
Universidad de Granada