Specified Clinical Study of Bioabsorbable Headless Compression Screw MF-001 made of Magnesium Alloy

Mishima Hajime0 个研究点目标入组 15 人开始时间: 2023年9月29日最近更新: 2024年4月1日

试验速览

暂无简介。

•(1) Patients with fractures in the following areas as indicated by simple X-ray, CT and MRI images and who are indicated for fracture surgery using a headless compression screw
•(a) Forearm: radius and ulna
•(b) Hand: carpal bone (navicular bone, etc.), metacarpal bone, phalanges
•(2) Age at the time of consent is between 18 and 60 years old.
•3) Informed consent has been obtained and sufficient understanding of the study has been obtained.

•1 Patients with a history of previous surgery, infection, or tumor at the surgical site
•2 Patients who have participated in clinical studies of other investigational drugs or devices within 3 months of enrollment in this clinical study
•3 Patients with serious hepatic or renal disease (AST (GOT) or ALT (GPT) over 200 U, serum creatinine over 2.0 mg/dL)
•4 Patients with poorly controlled diabetes mellitus (HbA1c over 8%)
•5 Patients with underlying diseases that clearly reduce bone formation capacity (osteoporosis, other bone metabolism diseases, dialysis, etc.)
•6 Patients at high risk of infection during the perioperative period (rheumatoid arthritis patients on biologic agents, collagen disease patients taking steroids at a dose of 10 mg/day or more, etc.)
•7 Women who are pregnant or suspected to be pregnant, or who are breastfeeding
•8 Patients with a foreign body reaction or allergy to transplants, foreign bodies in the body (plastic cosmetic implants, metals, etc.), etc.
•9 Patients who do not have the capacity to give voluntary consent or who are unable to give written consent
•10 Other patients who are judged to be unsuitable as subjects by the investigators responsible for the study.

发起方

Mishima Hajime