NCT06034262招募中2 期
Evaluation of the Treatment of Symptomatic Proximal InterPhalangeal (PIP) Joint Osteoarthritis With a Treated, Devitalized and Sterile Amniotic Membrane of Umbilical Cord Placed in Joint Interposition
TBF Genie Tissulaire3 个研究点 分布在 1 个国家目标入组 14 人开始时间: 2024年10月7日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 14
- 试验地点
- 3
- 主要终点
- Change in the symptomatology related to the PIPJ OA
研究概览
简要总结
The aim of this open, prospective, multicenter trial is to evaluate the use of a sterile, devitalized, processed umbilical cord amniotic membrane implant placed in joint interposition in the treatment of PIP joint osteoarthritis.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female; age between 18 and 75 years.
- •Patient with symptomatic PIPJ OA.
- •Patient treated medically for functional signs for more than 3 months, without improvement, justifying a surgical intervention.
- •Patient with a QuickDash score > 33 points (converted to 50%).
- •Patient with pain, at rest, in the PIPJ ≥ 4/10 on a VAS.
- •Patient who received the study information and provided consent.
- •Member or beneficiary of a national health insurance plan.
排除标准
- •Pregnant or breastfeeding woman; woman without effective contraception.
- •Patient with signs of neuropathy with functional disorders such as hyperesthesia.
- •Patient with uncontrolled epilepsy or neuropathy that contraindicates locoregional anesthesia.
- •Person confined by a judicial or administrative decision.
- •Adult subjected to legal protection measures or unable to provide his/her consent.
研究组 & 干预措施
SclerFIX-IP
Experimental
Treated, devitalised and sterile graft of umbilical cord amniotic membrane
干预措施: SclerFIX-IP (Biological)
结局指标
主要结局
Change in the symptomatology related to the PIPJ OA
时间窗: 12 months
Quality of life related to PIPJ OA evaluated using Quick Disabilities of the Arm, Shoulder and Hand (QuickDASH) questionnaire (0 = no disability, 100 = most severe disability); a decrease of 25% of the score is expected between subject's inclusion and the 12-month postoperative visit
次要结局
- Absence of toxicity(Through study completion (12 months))
- Change in the treated finger mobility(3 months, 6 months, 12 months)
- Change in pain related to PIPJ OA(1 month, 3 months, 6 months, 12 months)
- No apparent joint space anomaly(12 months)
研究者
研究点 (3)
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