Combined Intra- and Extra-articular ACL Reconstruction Versus Isolated Intra-articular ACL Reconstruction: Prospective Multicenter Randomized Clinical Trial With Hamstring Autograft
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 146
- 试验地点
- 4
- 主要终点
- Clinical failure rate
研究概览
简要总结
Abstract
Introduction: Autologous hamstring tendons are the most commonly used grafts in ACL reconstruction worldwide. There are several ways to prepare the graft using these tendons. One can prioritize increasing the diameter of an isolated intra-articular graft or alternatively, using one graft limb as an extra-articular reinforcement via the anterolateral ligament (ALL) reconstruction, with both options aiming to reduce the re-rupture rate relative to traditional quadrupled hamstring grafts.
Objective: To compare, through a prospective and randomized clinical trial, intra and extra-articular ACL reconstruction with ALL using hamstring autograft versus isolated anatomical ACL reconstruction using quintuple or sextuple hamstring autograft.
Methods: 146 patients will be randomized into two groups of 73 patients. Patients included in the study will be evaluated preoperatively and after surgery at 3, 6, 9, 12, and 24 months postoperatively. The primary outcomes will be clinical failure rate and graft rerupture rate. Secondary outcomes will include functional capacity assessed through IKDC, Lysholm KOOS, and Tegner scores, pain using the VAS, as well as stability assessed by digital rolimeter and objective IKDC. Kinesiophobia and anxiety will be measured using the Tampa scale and Anxiety and Depression scale.
Keywords: Rupture, Anterior Cruciate Ligament, Anterior Cruciate Ligament Reconstruction
详细描述
- Introduction Arthroscopic reconstruction of the anterior cruciate ligament (ACL) is a well-established procedure known for its superiority over non-surgical treatment of this injury. However, failure rates following ACL reconstruction can vary from 3-6% in some patient cohorts up to 40% in patients at increased risk of re-injury Hamstring autograft are the most commonly used for ACL reconstruction. Considering that the final graft diameter inferior to 8mm is associated to increased failure rate, and that increased intra-articular diameter is considered a protective factor, the preparation of hamstring autografts influences the final outcome. Historically used quadrupled hamstring grafts have been progressively replaced in recent years by quintupled or sextupled graft configurations in order to increase final graft diameter.
However, instead of using configurations that prioritize increasing the final diameter of hamstring autografts, ACL reconstruction associated with extra-articular reconstruction of the anterolateral ligament (ALL) may be performed using a portion of the gracilis, prioritizing the reconstruction of the ALL rather than increasing the intra-articular graft diameter. The association of the ALL serves two main functions: to decrease rotational instability, which can reach up to 40% in high-risk patients, and to mechanically protect the graft.
In a comparative analysis pairing patients with similar characteristics, ACL + ALL reconstruction showed significantly lower rerupture rate compared to isolated ACL reconstruction: 3.5% versus 17.4%. In another comparative analysis also pairing patients for similarity, isolated ACL reconstruction with bone-patellar tendon-bone (BTB) autograft showed a 3x higher risk of rerupture compared to ACL + ALL reconstruction with hamstring autografts.
Thus, the investigators hypothesize that extra-articular reinforcement with ALL reconstruction associated with anatomical ACL reconstruction with hamstring autograft may improve knee stability and help reduce the re-injury rate compared to isolated anatomical reconstruction with quintuple or sextuple hamstrings that prioritize graft diameter, following a well-defined criterion of indication for patients at increased risk of re-injury. In this way, the investigators intend to compare two methods through a randomized clinical trial: intra- and extra-articular reconstruction of the ACL with ALL with hamstring autograft versus isolated anatomical reconstruction of the ACL with quintuple or sextuple hamstring autograft. 2. Hypothesis Anatomical ACL reconstruction associated with extra-articular ALL reconstruction with hamstring autograft will present better functional results, better stability, lower clinical failure rate, and lower graft rupture rate when compared to isolated intra-articular anatomical ACL reconstruction with quintuple or sextuple hamstring autograft. 3. Objectives To compare the functional results, stability, clinical failure rate, and graft rupture rate of individuals undergoing anatomical ACL reconstruction associated with extra-articular ALL reconstruction with hamstring autograft compared to isolated intra-articular anatomical ACL reconstruction with quintuple or sextuple hamstring autograft. 4. Group Formation and Intervention Description
After randomization, two groups will be formed:
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
- None
盲法说明
Blinding after the assignment of patients to their group will be done as follows:
- Participants: No blinding.
- Investigators: No blinding.
- Intervention providers: No blinding.
- Data recorders: Partial blinding.
- Outcome assessors: No blinding.
- Data analysts, statisticians: Blinding. The statistician will only know the group of each patient after the statistical analysis is complete.
- Care providers: No blinding.
入排标准
- 年龄范围
- 14 Years 至 40 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients from the hospital's demand (emergency care and outpatient care) and from CROSS (Center for Regulation of Health Service Offers) who present one or more risk factors will be included:
- •Age (Female 14 years - 25 years and Male 16 years - 25 years);
- •Pivot-shift test > 2;
- •Chronic ACL injury (>12 months);
- •Athlete (Tegner Scale ≥ 7);
- •Tibial slope > 12 degrees;
- •Recurvatum > 5 degrees and < 15 degrees (asymmetric);
- •Ligamentous Hypermobility (Beighton Scale > 5).
- •Non-Inclusion Criteria
- •Individuals over 40 years of age will not be included;
- •ACL revision;
- •PCL injury (grade 2 and 3);
- •MCL injury (grade 2 and 3) or (grade 1 with valgus aligned axis);
- •CPL injury (grade 2 and 3 according to Fanelli classification);
- •Recurrent patellar dislocation;
- •Severe chondral lesion (ICRS grade 3 and 4) larger than 1cm2;
- •Previous ipsilateral knee surgery;
- •Kellgren Lawrence grade 3 or more;
- •Autoimmune/rheumatologic inflammatory disease;
- •Contralateral knee ligament injury;
- •Malalignment > 5 degrees clinical asymmetry between limbs or symmetric > 10 degrees axis deviation to varus (corresponding to > 4 degrees varus between the anatomical axis of the femur and the anatomical axis of the tibia in the clinical examination) or > 10 degrees axis deviation to valgus (corresponding to > 16 degrees valgus between the anatomical axis of the femur and the anatomical axis of the tibia in the clinical examination);
- •Graft diameter < 7 mm;
- •BMI > 35 or < 18;
- •Active or undergoing treatment for malignant neoplasia;
- •Pregnancy or suspected pregnancy;
- •Psychiatric disorders.
排除标准
- •Leave of absence from work due to disability or reduced income assistance (worker's compensation) whenever one of the investigators considers that the participant may be simulating a worse health condition than reality in order to receive financial assistance with work leave.
结局指标
主要结局
Clinical failure rate
时间窗: Minimum 2 years
Persistence of pivot shift (grade 1 or higher) in more than one postoperative evaluation compared to the contralateral knee, or a grade 2 or higher pivot shift at any postoperative evaluation.
Graft rupture rate
时间窗: Minimum 2 years
Graft rupture will be defined as a graft tear confirmed by magnetic resonance imaging (MRI) or arthroscopy in the presence of any clinical failure criteria.
次要结局
- Functional capacity 1(Minimum 2 years)
- Functional capacity 2(Minimum 2 years)
- Stability 1(Minimum 2 years)
- Anxiety Scale(Minimum 2 years)
- Stability 2(Minimum 2 years)
- Kinesiophobia(Minimum 2 years)
- Pain Scale(Minimum 2 years)
- Functional capacity 3(Minimum 2 years)
- Functional capacity 4(Minimum 2 years)
- Stability 3(Minimum 2 years)
- Stability 4(Minimum 2 years)
研究者
Marcos Vinicius Credidio
Federal University of São Paulo
Federal University of São Paulo