Clinical and Comparative Evaluation of the Results of Autograft Healing of the Tendon of the Semitendinus Muscle in the Tibial Canal, After Reconstruction of the Anterior Cruciate Ligament of the Knee Joint, by the Method of Stabilization of the Screw With a Bioabsorbable Method, With or Without the Use of Autogenous Spongiform Bone Grafts.
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Visual Analogue Score (VAS)
研究概览
简要总结
Clinical and comparative evaluation of the results of autograft healing of the tendon of the semitendinus muscle in the tibial canal, after reconstruction of the anterior cruciate ligament of the knee joint, by the method of stabilization of the screw with a bioabsorbable method, with or without the use of autogenous spongiform bone grafts.
详细描述
Assessment of the results of autograft healing of the tendon of the semitendinus muscle in the tibial canal, after the reconstruction of the anterior cruciate ligament (ACL) of the knee joint using the arthroscopic technique, with the method of tibial stabilization with a bioabsorbable screw (Arthrex) with the use of autogenous transplantation of spongy bone, drilling of the tibial canal inserted into the tibial canal prior to insertion of the screw. The detailed objectives are: comparison of the treatment results - healing and reconstruction of the autograft of the semitendinus tendon in the tibial canal of the knee joint, obtained in the study groups using two methods:
A- stabilization of the tibial attachment with a bioabsorbable screw (Arthrex) with simultaneous application to the tibial canal of autogenous cancellous bone grafts taken during the drilling of this canal and
B- stabilization of the tibial insertion with a bioabsorbable screw (Arthrex) without simultaneous application of autogenous cancellous bone grafts to the tibial canal.
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
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18-65 years;
- •Surgery for ACL damage to the knee joint;
- •Arthroscopic surgery;
- •No prior knee surgical interventions;
- •No additional pathologies in this anatomical area;
- •Informed consent of the patient to participate in the study.
排除标准
- •Age under 18 or over 65;
- •Previous surgical interventions in the examined anatomical area;
- •Additional pathologies in this area identified as part of preoperative diagnostics;
- •Damage to the second knee joint;
- •Failure to comply with the rigor of the same rehabilitation treatment protocol.
结局指标
主要结局
Visual Analogue Score (VAS)
时间窗: 6 months after procedure
Visual Analogue Score - subjective measure for acute and chronic pain. 100-mm VAS ratings of: * 0 to 4 mm can be considered no pain; * 5 to 44 mm, mild pain; * 45 to 74 mm, moderate pain; * 75 to 100 mm, severe pain.
IKDC SUBJECTIVE KNEE EVALUATION FORM
时间窗: 6 months after procedure
Interpreted as a measure of function, such that higher scores represent higher levels of function and lower levels of symptoms. A score of 100 is interpreted to mean no limitation with sporting activities or daily living and the complete absence of symptoms.
Body Mass Index (BMI)
时间窗: 6 months after procedure
BMI is interpreted using standard weight status categories: I : below 18.5 kg/m2 - underweight; II : 18.5 - 24.9 kg/m2 - healthy weight; III : 25.0 - 29.9 kg/m2 - overweight; IV : 30.0 kg/m2 and above - obesity.
Magnetic resonance imaging (MRI)
时间窗: 6 months after procedure
1,5 Tesli
Ultrasonography (USG)
时间窗: 6 months after procedure
Ultrasound examination on the apparatus with the option of elastometry
Biomechanical examination
时间窗: 6 months after procedure
On the Biodex 3 System measuring device
Tegner Activity Scale (TAS)
时间窗: 6 months after procedure
The Tegner Activity Scale (TAS) aims to provide a standardized method in determining the level of activity prior to injury and level of activity post injury that can be documented on a numerical scale. The Tegner activity scale is a one-item score that graded activity based on work and sports activities on a scale of 0 to 10. Zero represents disability because of knee problems and 10 represents national or international level soccer.
Tegner Lysholm Knee Scoring Scale
时间窗: 6 months after procedure
The Tegner Lyshom Knee Scoring Scale is a patient-reported instrument that consists of subscales for pain, instability, locking, swelling, limp, stair climbing, squatting, and the need for support. Scores range from 0 (worse disability) to 100 (less disability). Grading the Tegner Lysholm Knee Scoring Scale: * \<65 - poor; * 65-83 - fair; * 84-90 - good; * \>90 - excellent.
次要结局
未报告次要终点