NCT05250726已完成2 期
Evaluation of the Treatment of Symptomatic Scaphotrapeziotrapezoidal (STT) Osteoarthritis with a Treated, Devitalized and Sterile Meniscus Segment (MENISC-T) Placed in Joint Interposition
TBF Genie Tissulaire1 个研究点 分布在 1 个国家目标入组 14 人开始时间: 2021年1月1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
- 已完成
- 发起方
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- Decrease of the symptomatology related to the STT OA
研究概览
简要总结
The purpose of this open, prospective and multi center trial is to evaluate the use of a treated, devitalized and sterile meniscus implant placed in joint interposition in the treatment of STT 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 STT 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 wrist pain (VAS) in front of the STT joint at rest > 4/
- •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 functional rhizarthrosis that has not been stabilized or treated medically or surgically.
- •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
MENISC-T
Experimental
Segmented, devitalized and sterile meniscus graft
干预措施: MENISC-T (Biological)
结局指标
主要结局
Decrease of the symptomatology related to the STT OA
时间窗: 12 months
Quality of life related to STT 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
- Increase of thumb strength(1 month, 3 months, 6 months, 12 months)
- Absence of toxicity(Through study completion - average of 12 months)
- Decrease of pain related to STT OA(1 month, 3 months, 6 months, 12 months)
- No apparent anomaly of joint space(12 months)
研究者
研究点 (1)
Loading locations...
相似试验
招募中
2 期
Use of a Treated, Devitalized and Sterile Umbilical Cord Amniotic Membrane in the Treatment of STT OsteoarthritisOsteoarthritis HandNCT06038331TBF Genie Tissulaire14
招募中
2 期
Use of a Treated, Devitalized and Sterile Umbilical Cord Amniotic Membrane in the Treatment of PIP Joint OsteoarthritisOsteoarthritis HandNCT06034262TBF Genie Tissulaire14
Unknown
不适用
Trial Comparing SOC +Skin IQ MCM vs SOC for Pressure Ulcer (PU)Pressure UlcerNCT02363842Arjohuntleigh160
已完成
3 期
An Approved Drug to Study a New Indication for Seasonal Allergic Rhinitis in Patients With Asthma (0476-269)Rhinitis, Allergic, SeasonalAsthma, BronchialNCT00092885Organon and Co831
已完成
不适用
Assess Efficacy and Safety of a Nasal Spray in Adults With Dry or Irritated NoseDry NoseNCT06110117Church & Dwight Company, Inc.70