臨床研究等提出・公開システム

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

MF-001 trial

Mishima Hajime

University of Tsukuba Hospital

2-1-1, Amakubo, Tsukuba, Ibaraki

hmishima@tsukuba-seikei.jp

Noguchi Hiroshi

University of Tsukuba Hospital

2-1-1, Amakubo, Tsukuba, Ibaraki

+81-29-853-3219

noguhiro0164@tsukuba-seikei.jp

Recruiting

Sept. 29, 2023

Interventional

single arm study

open(masking not used)

uncontrolled control

single assignment

treatment purpose

(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 80 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.

Both

Fracture of forearm or hand

Treatment of this study is performed using a bioabsorbable headless compression screw made of a new magnesium alloy from Japan.

Radius and ulna fractures, carpal fractures, phalangeal fractures, metacarpal fractures

Magnesium alloy screws, bioabsorbable metal implants, headless compression screws

All adverse events and failures associated with this study (surgical treatment with this product)

<Safety endpoints>
Presence or absence of dislocation of the fracture repair site
Semi-quantitative evaluation of periscrew translucency
Magnesium blood level

<Efficacy endpoints:>
Bone fusion achievement rate (3 months and 6 months postoperatively)
Functional assessment (3 months and 6 months postoperatively)
All patients;
Patient-assisted functional assessments (QuickDASH score, Hand20)
Forearm and carpal fracture cases;
Mayo wrist score (4-item evaluation of pain, function, joint range of motion, and grip strength)
Metacarpal and phalanx fracture case;
%TAM (percentage of total range of motion of MP/PIP/DIP joints compared to the healthy side)
TPD (tip palm distance)

+81-29-853-3914

Sept. 26, 2023

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