A Comparative Prospective Study of Meniscal Repair Methods in Young Patients With Traumatic Meniscal Tears.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Pediatric International Documentation Committee Subjective (Pedi-IKDC) Knee Form.
研究概览
简要总结
Performing arthroscopic meniscus repair following a traumatic meniscus tear as an alternative to a meniscectomy is now an acceptable choice. Preserving meniscus tissues is crucial due to the significant role they play as an essential part of the knee joint. It is essential to comprehend the additional tools that can impact the recovery of the meniscus after suturing. Patients have been randomly assigned into two groups using the computer "www.randomiser.org," and the treatment outcomes were compared after one year. One group of patients has received a standard meniscus suturing technique, whereas another group has experienced the meniscus suturing treatment with an additional fibrin clot approach. Data pertaining to demographics, clinical characteristics, radiological findings, and survey responses have been carefully collected prospectively.
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
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 0 Years 至 19 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Individuals who provide consent to participate in the study, including patients and their care providers. The inclusion criteria for this study are as follows: being under the age of 19, having a traumatic isolated full-thickness meniscal tear longer than 1cm that has been confirmed by both preoperative MRI and arthroscopy, and not having undergone any previous surgery on the affected knee.
排除标准
- •This investigation excludes patients with developmental disabilities who are unable to read or interpret in their native language.
研究组 & 干预措施
Cohort I of patients
Individuals who undergo the conventional arthroscopic meniscus repair procedure
干预措施: Arthroscopic meniscus repair (Procedure)
Cohort II of patients
Patients who receive the supplementary fibrin clot augmentation during the arthroscopic meniscus repair operation.
干预措施: Arthroscopic meniscus repair (Procedure)
结局指标
主要结局
Pediatric International Documentation Committee Subjective (Pedi-IKDC) Knee Form.
时间窗: before treatment, after 12 months and 24 months following treatment
Pedi-IKDC is used to measure knee-related symptoms, function, and sports activity among children. The questionnaire consists of 13 items, each of which is scored using one of three rating systems: a range of 0 to 10 for items 2, 3, 12, and 13, a range of 0 to 4 for items 1, 4, 5, 6, 9, and 10, and a range of 0 to 1 for items 7 and 8. The 11th item consists of nine subquestions, each of which can be scored from 0 to 4. The overall score value is calculated by adding only the responses to 12 items and dividing the total by 92 (the highest number of points attainable). The score runs from 0 (worst case scenario) to 100 (best case scenario). The Pedi-IKDC has been proven to be a valid, trustworthy, and responsive questionnaire in a paediatric population with varied knee disorders, especially ligament and meniscal injuries, joint instability, and other disorders
Lysholm knee scale
时间窗: before treatment, after 12 months and 24 months following treatment
Lysholm knee scoring scale has been proven to be suitable for a variety of knee pathologies and also for the adolescent population. The scale comprises eight items. Higher values of the score indicate better functioning of the knee. (range from 0 to 100).
Health-related paediatric quality of life (PedsQL)
时间窗: before treatment, after 12 months and 24 months following treatment
PedsQL is a generic score, which estimates the quality of life of paediatric patients. The questionnaire consists of four domains with 23 questions: the general physical functioning, emotional, social, and functioning at school domains
Pediatric International Documentation Committee Subjective (Pedi-IKDC) Knee Form.
时间窗: before treatment, after 12 months and 24 months following treatment
Pedi-IKDC is used to measure knee-related symptoms, function, and sports activity among children. The questionnaire consists of 13 items, each of which is scored using one of three rating systems: a range of 0 to 10 for items 2, 3, 12, and 13, a range of 0 to 4 for items 1, 4, 5, 6, 9, and 10, and a range of 0 to 1 for items 7 and 8. The 11th item consists of nine subquestions, each of which can be scored from 0 to 4. The overall score value is calculated by adding only the responses to 12 items and dividing the total by 92 (the highest number of points attainable). The score runs from 0 (worst case scenario) to 100 (best case scenario). The Pedi-IKDC has been proven to be a valid, trustworthy, and responsive questionnaire in a paediatric population with varied knee disorders, especially ligament and meniscal injuries, joint instability, and other disorders
Lysholm knee scale
时间窗: before treatment, after 12 months and 24 months following treatment
Lysholm knee scoring scale has been proven to be suitable for a variety of knee pathologies and also for the adolescent population. The scale comprises eight items. Higher values of the score indicate better functioning of the knee. (range from 0 to 100).
Health-related paediatric quality of life (PedsQL)
时间窗: before treatment, after 12 months and 24 months following treatment
PedsQL is a generic score, which estimates the quality of life of paediatric patients. The questionnaire consists of four domains with 23 questions: the general physical functioning, emotional, social, and functioning at school domains
次要结局
- Clinical evaluation at 12 and 24 months postoperatively. The clinical assessment involves evaluating of pain, swelling and estimating and comparing the range of motion of the knee with the contralateral side.(12 and 24 months postoperatively.)
- magnetic resonance imaging (MRI scan) of the knee(before treatment, after 12 months and 24 months following treatment)
- Revision rates (secondary arthroscopies)(12 and 24 month following primary surgery)
研究者
Viktorija Brogaite
Viktorija Brogaite Martinkeniene MD
Vilnius University