Clinical-instrumental Evaluation and Assessment of Return to Sports Activity in Patients Surgically Treated for Isolated "Stener-like" Lesions of the Medial Collateral Ligament (MCL) or in the Context of Multiligament Injuries and Articular Fractures
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 43
- 试验地点
- 1
- 主要终点
- Lysholm Knee Score
研究概览
简要总结
The knee is a complex joint stabilized by four main ligaments: the anterior and posterior cruciate ligaments and the medial and lateral collateral ligaments. Multiligamentous knee injuries involve at least two ligaments and usually result from high-energy trauma, causing significant functional limitations.
One specific injury is the "Stener-like" lesion of the medial collateral ligament (MCL), characterized by an avulsion at its distal tibial insertion with interposition of tendons from the pes anserinus, which prevents natural healing. This lesion often occurs with other ligament or bone injuries and requires surgical treatment.
Diagnosis is clinical, supported by MRI to confirm the distal lesion and tendon interposition. Despite its importance, literature on this injury is scarce, with only a few studies and case reports, often limited by small sample sizes and lack of standardized follow-up assessments.
Due to the rarity and complexity of these injuries, there is a need for a comprehensive clinical study with standardized evaluations to improve understanding and develop standardized surgical treatments for isolated and associated Stener-like MCL lesions.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 12 Years 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients of both male and female sex.
- •Patients who underwent surgical re-insertion of the distal insertion of the medial collateral ligament starting from 01/01/2020 and all patients scheduled for this type of surgical intervention until 12/31/2027;
- •Patients aged between 12 and 65 years at the time of surgery;
- •Patients who underwent isolated distal medial collateral ligament re-insertion surgery, as well as those who underwent the same procedure combined with other interventions on the same knee (e.g., multiligament injuries, reduction and osteosynthesis of bone fractures);
- •Patients who have given consent to participate in the study;
- •Patients who have undergone preoperative radiological investigations of the affected knee confirming the diagnosis of distal medial collateral ligament injury (MRI in the case of ligament injuries; X-ray and/or CT scan in the case of articular fractures).
排除标准
- •Previous fractures of the same limb treated surgically.
- •Patient age under 12 years at the time of surgery or patients over 65 years of age.
- •Patients who have not provided informed consent.
- •Patients who are no longer contactable.
- •Patients who have not engaged in sports activity in the 2 years prior to the surgical intervention.
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 function through 8 items, which help determine the condition of the knee in relation to the functional demands of daily activities. This assessment tool is used to evaluate the outcomes of surgery in patients operated on for ligament or meniscal injuries of the knee. The final score is obtained by summing the scores from the different items and ranges 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
- KT-1000 Arthrometer(At least 24 months after surgery)
- KIRA Accelerometer(At least 24 months after surgery)
- Anterior drawer test(At least 24 months after surgery)
- Return to sports(At least 24 months after surgery)
- VAS (Visual Analog Scale)(At least 24 months after surgery)
- Tegner Score(At least 24 months after surgery)
- International Knee Documentation Committee (IKDC)(At least 24 months after surgery)
- Complications or Subsequent Interventions(At least 24 months after surgery)
- Radiographic Evaluation(At least 24 months after surgery)
研究者
Stefano Zaffagnini
Full Professor Medicine and Surgery, University of Bologna
Istituto Ortopedico Rizzoli