Long-term Clinical and Radiographic Results of Revision Anterior Cruciate Ligament Reconstruction Using Over The Top Single-bundle Technique and Lateral Extra-articular Tenodesis With Achilles Tendon Allograft.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 59
- 试验地点
- 2
- 主要终点
- Lysholm Knee Score
研究概览
简要总结
Several techniques for revision of anterior cruciate ligament (ACL) reconstruction and different types of grafts have been used over the years. These include single-bundle techniques, double-bundle techniques, and single-bundle techniques with external tenodesis. We also distinguish between the use of autografts and grafts from donors, or allografts.
The choice of surgical technique and graft type is strongly influenced by the progression of damage characterizing these patients (meniscal, chondral, or ligamentous), the surgical decisions made during the initial surgery (graft used, orientation, and number of bone tunnels), or any complications that occurred.
The use of a specific type of graft is heavily dependent on its availability: it is likely that the first-choice graft for some surgeons may be unavailable because it has already been used. The use of allografts is now commonly accepted by the scientific community, with the Achilles tendon standing out for its biomechanical properties and size. Unlike autografts, it does not damage the patient's ligamentous tissue, which is thus preserved.
Since osteoarthritis is one of the most debated consequences of anterior cruciate ligament revision, an analysis of the results is essential to provide a clearer understanding of the risks and benefits associated with the different types of procedures.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 18 and 50 years at the time of surgery;
- •Male and female gender;
- •Patients who have undergone revision of anterior cruciate ligament reconstruction with a single-bundle "Over-The-Top" technique and external tenodesis using Achilles tendon allograft, with or without associated procedures, at least 2 years post-surgery;
- •A radiograph taken immediately before or after the surgery of the affected knee;
- •Patients who have provided consent to participate in the study.
排除标准
- •Patients no longer accessible;
- •Patients who deny consent to participate in the study;
- •Advanced knee osteoarthritis (Outerbridge grade III-IV) at the time of surgery;
- •Severe obesity (BMI > 35);
- •Lower limb conditions that prevent the patient from maintaining an upright position with full weight-bearing during the assessment;
- •Infection or hematological or rheumatic conditions at the time of the assessment.
结局指标
主要结局
Lysholm Knee Score
时间窗: At least 24 months after surgery
It is a validated measurement scale that assesses knee functionality through 8 items, allowing the evaluation of the knee's condition in relation to the functional demands of daily activities. This assessment tool is used to evaluate the outcomes of surgery in patients who have undergone surgery for ligamentous or meniscal knee injuries. The final score is obtained by summing the various scores from the different items, ranging from 0 to 100. The scores are divided into subgroups: Excellent (95-100); Good (84-94); Fair (65-83); Poor (\<64).
次要结局
- Physical examination(At least 24 months after surgery)
- Anterior drawer test(24 months after surgery)
- Lachman test(At least 24 months after surgery)
- Pivot shift test(At least 24 months after surgery)
- International Knee Documentation Committee (IKDC)(At least 24 months after surgery)
- VAS(At least 24 months after surgery)
- Tegner score(At least 24 months after surgery)
- PASS score(At least 24 months after surgery)
- Weight-bearing X-ray of the operated knee (Kellgren-Lawrence scale).(At least 24 months after surgery)
- KT-1000(At least 24 months after surgery)
- KYRA(At least 24 months after surgery)
研究者
Stefano Zaffagnini
Full Professor Medicine and Surgery, University of Bologna
Istituto Ortopedico Rizzoli