Eco-guided Treatment With Triamcinolone-Acetonide in the Treatment of Medial Plica Syndrome - A Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- KUJALA Scale (Kujala Anterior Knee Pain Scale (AKPS
研究概览
简要总结
The aim of this pilot study is to evaluate the clinical and radiological outcomes (ultrasound and MRI) for a treatment utilized in the medial plica syndrome resistant to conservative therapy. Will be evaluated an intra-plica ultrasound-guided injections of Triamcinolone-Acetonide and lidocaine percutaneously, and associated rehabilitation therapy. The aim of the study will be to evaluate the efficacy and safety of the injection procedure by revealing clinical improvement and monitoring the incidence of adverse events following treatment.
详细描述
30 patients affected by the medial plica syndrome will be included in a pilot study in which one will be evaluated the effect of treatment with Triamcinolone-Acetonide and Lidocaine, injected intraplical with an ultrasound-guided procedure. For evaluating the treatment, will be considered functional and pain outcomes. Patients will be evaluated before treatment by a clinical, an MRI and an ultrasound examination. After the injection, they will be followed up at 1, 3, 6 and 12 months. At the 1 and 3 month FU visits patients will be evaluated by an ultrasound examination and at the 6 month FU they will be evaluated by an MRI examination.
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 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ultrasonographic and/or MRI signs of medial plica pathology;
- •VAS pain 4-8 at time of inclusion;
- •Failure, defined as the persistence of symptomatology, after at least one course of conservative treatment of at least 6 weeks (rest and drug treatment, physiotherapy);
- •Ability and consent of patients to actively participate in clinical follow-up;
排除标准
- •Patients with: rheumatic diseases, diabetes, infectious processes, epilepsy, severe stage osteoporosis
- •Patients undergoing intra-tendon infiltration of other substance within the previous 6 months;
- •Patients undergoing surgery on the affected knee within the previous 12 months;
- •Patients undergoing femoro- patellar joint stabilization surgery to the affected knee;
- •Trauma to the affected knee within the past 6 months;
- •Episodes of patellar dislocation and subluxation to the affected knee;
- •State of immunodepression;
- •Ongoing systemic inflammatory diseases (stabilized outcomes of these diseases are not considered absolute contraindications).
- •Contraindications to use or hypersensitivity to the active ingredient (Triamcinolone Acetonide) or to the excipients (sodium chloride, benzyl alcohol, sodium carboxymethylcellulose, polysorbate 80 and water for injectable preparations)found within Kenacort as per the product package insert;
- •12. Contraindications or hypersensitivity to the active ingredient of the local anesthetic (Lidocaine) or their excipients;
- •Pregnancy or lactation status or intention to become pregnant during the period of study participation. In particular, in the case of a suspected pregnancy , this will be excluded by serological testing (hCG).
结局指标
主要结局
KUJALA Scale (Kujala Anterior Knee Pain Scale (AKPS
时间窗: 6 months FU
This is a patient-reported assessment of patellofemoral disorders that evaluates subjective symptoms and functional limitations. The evaluation consist of 13 questions with a total score of 100 points.
次要结局
- MRI assessment(baseline, 6 months FU)
- Final treatment opinion(24 months follow-up)
- Patient Rehabilitation Monitoring(12 months follow-up)
- VAS (Visual Analogue Scale)(baseline, 1 month, 3 months, 6 and 12 months FU)
- Ultrasound assessment(baseline, 1 month, 3 months FU)
- Patient Acceptable Symptom State (PASS)(baseline, 1 month, 3 months, 6 and 12 months, 24 months FU)
- KOOS (Knee Injury and Osteoarthritis Outcome Score)(baseline, 1 month, 3 months, 6 and 12 months FU)