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The Efficacy and Safety of Magnesium Alloy Screw as a Novel Bioabsorbable Material in Patients Due to Hand Fractures

NCT02456415 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2015-09-15

No results posted yet for this study

Summary

This study evaluates the safety and efficacy of biodegradable magnesium alloy screw, in patients with hand fractures who require internal fixation (to obtain a product license from the Ministry of Food and Drug Safety in Korea (MFDS)).

Conditions

  • Hand Fractures

Interventions

DEVICE

K-MET™ Bioresorbable Bone screw

The biodegradable screw inserted into bone with an appropriate driver is slowly degraded and is completely degraded after completion of bone union and absorbed into the body. The screw is indicated for fixing damaged bone.

Sponsors & Collaborators

  • U&I Corporation

    lead OTHER

Principal Investigators

  • Gyeong-jin Han, professor · Ajou Univ hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-07-31
Primary Completion
2014-11-30
Completion
2014-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02456415 on ClinicalTrials.gov