JPRN-jRCT2052200081进行中（未招募）3 期
Physician-initiated clinical trial to verify the effectiveness and safety of a custom-made surgical guide in corrective surgery for malunited intra-articular wrist fracture(Multicenter, open-label, single-arm study)
Murase Tsuyoshi0 个研究点目标入组 12 人开始时间: 2020年11月6日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 12
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 18age old 至 <= 75age old（—）
- 性别
- All
入选标准
- •1) Patients with wrist disorder* due to articular incongruity** caused by malunited intra-articular fracture of the distal radius
- •(*: One or more of the following symptoms or findings; restricted range of joint motion, pain, pre- or early stage osteoarthritis on plain radiograph)
- •(**: 2.0 mm or more joint surface step-off on CT image)
- •2) Patients who have been suffering for more than 3 months after receiving intra-articular fracture of the wrist
- •3) Patients 18 years or older and 75 years or younger at the time of obtaining consent (both male and female)
- •4) Patients for whom written consent has been obtained
排除标准
- •1) Patients who were diagnosed to be unsuitable for intra-articular corrective osteotomy due to deformity associated with severe crushing and complicated external joint fracture
- •2) Patients who have advanced to end-stage osteoarthritis in the target joint and are diagnosed not to be eligible for intra-articular corrective osteotomy
- •3) Patients who are not suitable for general anesthesia or regional transmission anesthesia
- •4) Patients with active malignancy
- •5) Patients with rheumatoid arthritis or related diseases
- •6) Patients who are pregnant or may be pregnant, and those who wish to become pregnant during this study participation period
- •7) Patients who are unable to restrict anticoagulant medication or anticoagulant therapy for the surgery
- •8) Patients who have a hemorrhagic diathesis and are difficult to apply for surgery.
- •9) Patients with systemic infection
- •10) Patients with hypersensitivity to custom surgical guides or their component materials
- •11) Patients who have difficulty in CT simulation due to reasons such as indwelling of metal implants in the surgical site
- •12) Patients who participated in other clinical trials or clinical studies within 1 month before signed the consent form for the clinical trial
- •13) Patients who are judged by the investigator or sub-investigator to be unable to correctly understand the significance of the clinical trial and to follow the compliance requirements due to mental illness, etc.
- •14) Other patients for whom the investigator or subinvestigator has judged participation in the study to be inappropriate
研究者
相似试验
招募中
Unknown
Physician-initiated clinical trial to evaluate the efficacy of intra-articular injection of platelet-rich plasma (PRP) for knee osteoarthritis: a multicenter, randomized, double-blind, comparative studyOsteoarthritis of the KneeJPRN-jRCT2032220677Sato Masato116
招募中
Unknown
Physician-led clinical trial for the development of PMS-2, a device to objectively monitor the efficacy of analgesic drugs for postoperative paiJPRN-jRCT1052230029akai Kunihiro30
已完成
不适用
Phase I/II clinical trial of verification for the safety and efficacy of Amitose-Bis-glyceryl ascorbate-containing cream in renal cell carcinoma patients treated by sunitinibRenal cell carcinomaJPRN-UMIN000027209Kobe University Hospital24
已完成
不适用
A clinical trial to determine the Efficacy and Safety of Succare in patients with diabetes mellitus (Type 1 and Type 2)CTRI/2014/01/004311atural Solutions30
招募中
不适用
Clinical trial to verify the efficacy and safety of improvement of lower extremity muscle function and balance therapy using Electric Orthopedic Exercise Device(WALK WELL™) in hemiplegic stroke patientsKCT0004558Chonbuk National University Hospital30