NCT03867305已完成不适用
Evaluation of the Action of MOBIDERM® on Periarticular Edema After Total Knee Prosthesis - Randomized Controlled Pilot Study
Centre Hospitalier Universitaire de Nīmes2 个研究点 分布在 1 个国家目标入组 44 人开始时间: 2019年7月26日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 44
- 试验地点
- 2
- 主要终点
- Knee volume
研究概览
简要总结
We hypothesize that the use of MOBIDERM® after total knee prosthesis allows a greater and faster resorption of periarticular edema:
- improvement of knee flexion;
- faster functional gain;
- faster decrease in postoperative pain by decreasing tissue tension.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient requiring a first total knee prosthesis (scheduled between Tuesday and Friday).
- •Patient that has given his/her free and informed consent and signed the consent form.
- •The patient must be a member or beneficiary of a health insurance plan
- •The patient is at least 18 years old (≥) and under 90 years old (<).
排除标准
- •The subject is in a period of exclusion determined by a previous study (therapeutic study)
- •The subject refuses to sign the consent
- •It is impossible to give the subject informed information
- •The patient is under safeguard of justice or state guardianship
- •The patient is pregnant or breastfeeding
- •The patient is allergic to latex bandages.
- •The subject has contralateral amputation, pressure ulcers, severe Obstructive Arteriopathy of Lower Limbs, lymphoedema or thromboembolic event of the lower limb (ipsilateral and / or contralateral / superficial or deep or detected by postoperative Doppler).
- •The subject has chronic or active wounds or any cause that hinders normal rehabilitation or the application of a bandage.
- •patient with a stroke / Disabling Neurological Pathology, Chronic Immunological Pathology / Systemic Disease.
- •patient with Hepatic insufficiency.
- •patient with Venous insufficiency (stages 3 and 4).
- •The patient is on dialysis.
- •The subject has cognitive or behavioral disorders (Parkinson's disease, cerebellar syndrome, opposition, agitation, dementia).
- •The subject has a history of knee surgery.
结局指标
主要结局
Knee volume
时间窗: Month 1
unit: mm3
次要结局
- Presence of an ecchymosis in proximity to the scar(Month 1)
- visual analog pain scale visual analog pain scale(Month 1)
- Knee injury and Osteoarthritis Outcome (KOOS) score(month 1)
- Measurement of knee flexion / extension(Month 1)
- Surface area of ecchymosis in proximity to the scar(Month 1)
- Resolution of the ecchymosis in proximity to the scar(Month 1)
- Coloration of ecchymosis in proximity to the scar(Month 1)
研究者
研究点 (2)
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