Evaluation of Clinical and Radiological Outcomes in Patients Undergoing Fixation of Osteochondral Fragments With Reasorbable Screws in the Knee Joint
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- KOOS (Knee Injury and Ostearthritis Outcome Score) score
研究概览
简要总结
Various techniques for the fixation of unstable osteochondral fragments have been used over the years, each with associated advantages and disadvantages, and differing clinical outcomes. However, the literature on the treatment of this type of injury in the adolescent and young adult population is scarce and involves small case series. Failure to treat these injuries can lead to serious consequences such as chronic pain, residual joint stiffness, and the development of early osteoarthritis, necessitating more invasive and burdensome interventions for the national health system, such as prosthetic replacements or osteotomies.
Due to the lack of real consensus within the scientific community regarding the ideal treatment for these patients and the insufficient medium/long-term follow-up data on the effects of these injuries on articular cartilage in young patients, this study aims to evaluate the clinical and radiological conditions of patients undergoing osteochondral fragment fixation using the same surgical technique (fixation with resorbable screws performed arthroscopically or via open surgery depending on the lesion's location) in order to clarify preventive measures against cartilage degeneration following these injuries, which are very common in adolescence.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 年龄范围
- 12 Years 至 35 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients undergoing surgical fixation of osteochondral fragment using resorbable screw technique, either arthroscopically or via mini-open procedure depending on the lesion's location, from 01/01/2017, and all new patients eligible for this type of intervention until 31/12/
- •Patients aged between 12 and 35 years at the time of the surgical intervention.
- •Patients with the presence of osteochondral fragments confirmed by magnetic resonance imaging.
- •Patients with osteochondral lesions observed on imaging and symptoms attributable to the presence of osteochondral fragments.
- •Patients diagnosed with osteochondritis dissecans or recent contusion/sprain trauma.
排除标准
- •Patients with concomitant complex ligamentous injuries or fractures at the time of the intervention;
- •Patients who are no longer reachable;
- •Women of childbearing age who cannot exclude pregnancy;
- •Patients who are unable to provide informed consent or patients who are unwilling to sign the informed consent form.
结局指标
主要结局
KOOS (Knee Injury and Ostearthritis Outcome Score) score
时间窗: At least 24 months after surgery
It represents a subjective score composed of 42 questions divided into 5 main domains. These domains investigate various aspects of symptoms and daily activities as well as the quality of life related to the knee and are divided as follows: * Symptoms, composed of 7 questions, 2 of which pertain to stiffness; * Pain, composed of 9 questions; * Functions and daily activities, composed of 17 questions; * Sports and recreational activities, composed of 5 questions; * Quality of life in relation to the knee, composed of 4 questions. All questions use the same response format, utilizing a quantitative scale ranging from 0 (no issues) to 4 (severe difficulty). Scores are calculated separately for each domain and converted into a percentage score, where 100 represents excellent physical condition with no symptoms and 0 represents severe disability with limitations in daily activities and constant symptoms even at rest.
次要结局
- Anterior knee pain / pain during knee flexion(At least 24 months after surgery)
- Radiological evaluation (MRI, magnetic resonance imaging) throughout ICRS Cartilage Score(24 months after surgery)
- MARX Activity Rating Scale(At least 24 months after surgery)
- Sports Activity Level, Tegner Score(At least 24 months after surgery)
- Kujala Anterior Knee Pain Scale(At least 24 months after surgery)
- International Knee Documentation Committee (IKDC) Score(At least 24 months after surgery)
- Objective IKDC (IKDC standard evaluation form)(At least 24 months after surgery)
- VAS (Visual Analog Scale) for pain(At least 24 months after surgery)
- Radiological evaluation (MRI, magnetic resonance imaging) throughout Outerbridge Classification(24 months after surgery)
- Thigh circumference(At least 24 months after surgery)
- Likert scale(At least 24 months after surgery)
- Complications, subsequent interventions, or surgical failures(At least 24 months after surgery)
研究者
Stefano Zaffagnini
Full Professor Medicine and Surgery, University of Bologna
Istituto Ortopedico Rizzoli