Evaluation Of Clinical Results And Imaging Of Anterior Cruciate Ligament Reconstruction With Orthopure Xt
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Lysholm Knee Score
研究概览
简要总结
The purpose of this study is to evaluate subjective and objective clinical outcomes and imaging data of subjects undergoing reconstruction or revision of LCA reconstruction using OrthoPure XT
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Patients between the ages of 18 and 65 at the time of ACL reconstruction surgery;
- •Patients aged 35 to 65 at the time of primary ACL reconstruction surgery;
- •Male and female sex;
- •First injury of the ACL with impossibility of use of autograft (patellar tendinopathy, quadriceps tendinopathy, goose leg tendinopathy) or refusal to use allograft (Bank tendon);
- •Recurrence of ACL injury with impossibility of use of autograft (prior use/tendinopathy of the patellar, previous use/tendinopathy of the quadriceps, previous use/tendinopathy of the goose leg) or refusal to use allograft (tendon of Bank);
排除标准
- •Patients who do not consent to be included in the study
- •Presence of haematological, rheumatic or haemorrhagic disease time of assessment
- •ACL primary reconstruction in subjects under 35
- •Allergies and/or reactions from hypersensitivity or religious objection to the use of porcine derivation
- •Pregnant and/or breastfeeding women
研究组 & 干预措施
Experimental
Patients with anterior cruciate ligament injury, in which the patient's own autologous tendons cannot be used, will be treated with the ligamentous reconstruction device.
干预措施: Orthopure (Other)
结局指标
主要结局
Lysholm Knee Score
时间窗: After 24 months
The final score is obtained from the sum of the various scores obtained in the different and ranges from 0 to 100. Scores are divided into subgroups: Excellent (95-100); Good (84-94); Decent (65-83); Poor (\<64).
Tegner Score
时间窗: After 24 months
allows to estimate the level of motor activity of a subject with a score between 0 and 10, where 0 represents 'inability' and 10 represents 'participation in competitive sports
Visual Analogue Scale
时间窗: After 24 months
is a one-dimensional quantitative pain assessment scale at 10 points; the scale requires the patient to select the number that best describes the intensity of his pain, from 0 to 10, at that precise moment. 0 means no pain and 10 indicates the worst possible pain.
continuity of the graft
时间窗: After 24 months
assess the continuity of the graft with magnetic resonance imaging
International Knee Documentation Committee
时间窗: After 24 months
The score goes from 0 to 100 where the maximum is 100 and expresses the absence of limitations and symptoms, and therefore an excellent result; the further you go from this score and the worse the result, which can therefore be divided into four groups: excellent (80-100)good (60-80), good (30-60), bad (0-30)
International Knee Documentation Committee
时间窗: At baseline (day 0)
The score goes from 0 to 100 where the maximum is 100 and expresses the absence of limitations and symptoms, and therefore an excellent result; the further you go from this score and the worse the result, which can therefore be divided into four groups: excellent (80-100)good (60-80), good (30-60), bad (0-30)
International Knee Documentation Committee
时间窗: After 2 months
The score goes from 0 to 100 where the maximum is 100 and expresses the absence of limitations and symptoms, and therefore an excellent result; the further you go from this score and the worse the result, which can therefore be divided into four groups: excellent (80-100)good (60-80), good (30-60), bad (0-30)
International Knee Documentation Committee
时间窗: After 6 months
The score goes from 0 to 100 where the maximum is 100 and expresses the absence of limitations and symptoms, and therefore an excellent result; the further you go from this score and the worse the result, which can therefore be divided into four groups: excellent (80-100)good (60-80), good (30-60), bad (0-30)
Lysholm Knee Score
时间窗: At baseline (day 0)
The final score is obtained from the sum of the various scores obtained in the different and ranges from 0 to 100. Scores are divided into subgroups: Excellent (95-100); Good (84-94); Decent (65-83); Poor (\<64).
Lysholm Knee Score
时间窗: After 2 months
The final score is obtained from the sum of the various scores obtained in the different and ranges from 0 to 100. Scores are divided into subgroups: Excellent (95-100); Good (84-94); Decent (65-83); Poor (\<64).
Lysholm Knee Score
时间窗: After 6 months
The final score is obtained from the sum of the various scores obtained in the different and ranges from 0 to 100. Scores are divided into subgroups: Excellent (95-100); Good (84-94); Decent (65-83); Poor (\<64).
Visual Analogue Scale
时间窗: At baseline (day 0)
is a one-dimensional quantitative pain assessment scale at 10 points; the scale requires the patient to select the number that best describes the intensity of his pain, from 0 to 10, at that precise moment. 0 means no pain and 10 indicates the worst possible pain.
Visual Analogue Scale
时间窗: After 2 months
is a one-dimensional quantitative pain assessment scale at 10 points; the scale requires the patient to select the number that best describes the intensity of his pain, from 0 to 10, at that precise moment. 0 means no pain and 10 indicates the worst possible pain.
Visual Analogue Scale
时间窗: After 6 months
is a one-dimensional quantitative pain assessment scale at 10 points; the scale requires the patient to select the number that best describes the intensity of his pain, from 0 to 10, at that precise moment. 0 means no pain and 10 indicates the worst possible pain.
Tegner Score
时间窗: At baseline (day 0)
allows to estimate the level of motor activity of a subject with a score between 0 and 10, where 0 represents 'inability' and 10 represents 'participation in competitive sports
Tegner Score
时间窗: After 2 months
allows to estimate the level of motor activity of a subject with a score between 0 and 10, where 0 represents 'inability' and 10 represents 'participation in competitive sports
Tegner Score
时间窗: After 6 months
allows to estimate the level of motor activity of a subject with a score between 0 and 10, where 0 represents 'inability' and 10 represents 'participation in competitive sports
次要结局
未报告次要终点