Evaluation of the Performance of Six-month Wall Infiltration Under Ultrasound to Treat Stable Degenerative Meniscal Injuries. A Single-center, Randomized, Double-blind Study.
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- Lysholm score before infiltration (intra-articular group)
研究概览
简要总结
The main hypothesis of the study is that in situ infiltration of the meniscal lesion would provide patients with lasting and greater relief than intra-articular infiltration. A statistically significant difference would be if the Lysholm score of the meniscal wall group at 3 months is 9.5 points higher than that of the intra-articular infiltration group.
The aim is to evaluate the effectiveness of meniscal wall infiltration under ultrasound in the treatment of stable degenerative meniscal lesions versus intra-articular infiltration (Gold standard) at 3 months by Lysholm's algo-functional score.
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)
盲法说明
The patient will not know whether he has been randomized to the meniscal wall infiltration group or the intra-articular filtration group. The investigator following up the patients after infiltration will not know whether his:her patient has had an intra-articular infiltration or a meniscal wall infiltration.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with a symptomatic meniscal lesion of a degenerative nature, isolated or associated with early osteoarthritis or chondropathy (Ahlbach stages 1 and 2).
- •Indication for peri-meniscal infiltration under ultrasound control of the knee for a clinically stable degenerative meniscal lesion confirmed by MRI and radiography.
- •Patient who has given free and informed consent.
- •Patient who has signed the consent form.
- •Patient affiliated or beneficiary of a health insurance plan.
- •Adult patient (≥18 years of age).
排除标准
- •No iconographic evidence of meniscal injury.
- •Associated lesions of the central pivot of the knee.
- •Knee pain of osteoarthritic origin strongly suggested by the clinic associated with an advanced radiological stage of osteoarthritis (Ahlbach stages 3 and 4).
- •Presence of a skin lesion at the infiltration sites.
- •Suspected soft tissue or joint infection.
- •Patient participating in research involving human subjects defined as Category
- •Patient in an exclusion period as determined by another study.
- •Patient under court protection, guardianship or trusteeship.
- •Patient unable to give consent.
- •Patient for whom it is impossible to give informed information.
- •Pregnant, parturient or breastfeeding women.
研究组 & 干预措施
Meniscal wall infiltration group
Administration of Diprostene: 1 ml syringe of Betamethasone 2 mg; injectable suspension in pre-filled syringe under ultrasound control.
干预措施: Injection of corticosteroids (Diprostène®) (Drug)
Intra-articular infiltration group
The procedure is identical in all respects to the experimental group, except that the ultrasound procedure is mimicked and the infiltration of dexamethasone 2 mg (Diprostene®) is performed intra-articularly.
Administration Diprostene: 1 ml syringe of Betamethasone 2 mg; injectable suspension in pre-filled syringe.
干预措施: Injection of corticosteroids (Diprostène®) (Drug)
结局指标
主要结局
Lysholm score before infiltration (intra-articular group)
时间窗: 15 days before infiltration
The Lysholm score will be used to evaluate functionality 15 days before infiltration.The Lysholm Tegner score (Lysholm and Gillquist 1982) is a validated questionnaire for assessing knee functionality. The Lysholm score is rated from 0 to 100 (100 being the maximum functional score) and its repeatability is excellent (0.88 to 0.95). The scale has eight items: instability (/25), pain (/25), locking (/15), swelling (/10), stairs (/10), squatting (/5), limping (/5), use of a cane (/5). In 1985, Tegner added a scale of sports and occupational activity rated from 0 (occupational disability) to 10 (high level sport), hence the name Lysholm-Tegner score (Tegner and Lysholm 1985)
Lysholm score before infiltration (meniscal wall group)
时间窗: 15 days before infiltration
The Lysholm score will be used to evaluate functionality 15 days before infiltration.The Lysholm Tegner score (Lysholm and Gillquist 1982) is a validated questionnaire for assessing knee functionality. The Lysholm score is rated from 0 to 100 (100 being the maximum functional score) and its repeatability is excellent (0.88 to 0.95). The scale has eight items: instability (/25), pain (/25), locking (/15), swelling (/10), stairs (/10), squatting (/5), limping (/5), use of a cane (/5). In 1985, Tegner added a scale of sports and occupational activity rated from 0 (occupational disability) to 10 (high level sport), hence the name Lysholm-Tegner score (Tegner and Lysholm 1985)
Lysholm score after infiltration (intra-articular group)
时间窗: 3 months after infiltration
The Lysholm score will be used to evaluate functionality 3 months after infiltration.The Lysholm Tegner score (Lysholm and Gillquist 1982) is a validated questionnaire for assessing knee functionality. The Lysholm score is rated from 0 to 100 (100 being the maximum functional score) and its repeatability is excellent (0.88 to 0.95). The scale has eight items: instability (/25), pain (/25), locking (/15), swelling (/10), stairs (/10), squatting (/5), limping (/5), use of a cane (/5). In 1985, Tegner added a scale of sports and occupational activity rated from 0 (occupational disability) to 10 (high level sport), hence the name Lysholm-Tegner score (Tegner and Lysholm 1985)
Lysholm score after infiltration (meniscal wall group)
时间窗: 3 months after infiltration
The Lysholm score will be used to evaluate functionality 3 months after infiltration.The Lysholm Tegner score (Lysholm and Gillquist 1982) is a validated questionnaire for assessing knee functionality. The Lysholm score is rated from 0 to 100 (100 being the maximum functional score) and its repeatability is excellent (0.88 to 0.95). The scale has eight items: instability (/25), pain (/25), locking (/15), swelling (/10), stairs (/10), squatting (/5), limping (/5), use of a cane (/5). In 1985, Tegner added a scale of sports and occupational activity rated from 0 (occupational disability) to 10 (high level sport), hence the name Lysholm-Tegner score (Tegner and Lysholm 1985)
次要结局
- Return to physical activity (intra-articular infiltration group)(Day 0 to Month 6)
- Pain evaluated by the patient (intra-articular group)(12 weeks after infiltration)
- Adverse events in the intra-articular infiltration group(Day 0 to 3 months after infiltration)
- Adverse events in the meniscal wall infiltration group(Day 0 to 3 months after infiltration)
- Arthroscopy required within six months of infiltration: (intra-articular group)(6 months after infiltration)
- Arthroscopy required within six months of infiltration: (meniscal wall group)(6 months after infiltration)
- Return to physical activity (meniscal wall infiltration group)(Day 0 to Month 6)
- Pain evaluated by the patient (meniscal wall group)(12 weeks after infiltration)