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

NCT02456415 | Completed Phase 2 DMC

• 1 other identifier: UNI-01
• Study Type: interventional
• Target: 28
• Locations: 0 countries
• Sites: N/A

Brief 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

Outcome Measures

Primary Outcomes (1)

• Bone union

  Bone union was evaluated at 6-month after surgery according to the following definition.Definition of bone union is when simple X-ray findings reveal that bone trabeculae or cortical bone exceeds the fracture site. Non-union is defined as no union at 3-month post-surgery.

  up to 6 months

Secondary Outcomes (5)

• PROM(Passive Range of Motion)

  up to 6 months

• TAM(Total Active Motion)

  up to 6 months

• Power(grip strength and pick-up power)

  up to 6 months

• DASH scale

  3,6 months

• Pain as measured by the NRS (1~10)

  up to 6 months

Study Arms (1)

K-MET™ Bioresorbable Bone screw

EXPERIMENTAL

The K-MET™ Bioresorbable Bone Screw, intended to be used for trauma therapy, consists of Cortex screws, Cannulated headless screws. For Headless screw and Cannulated headless screws, the design is similar to normal headless compression screws but the compression function was achieved by using different lengths for the front and rear pitches. These screws are dynamic and allow therewith the fracture at the Carpal, metacarpal, and small hand bone.

Device: K-MET™ Bioresorbable Bone screw

Interventions

K-MET™ Bioresorbable Bone screw DEVICE

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.

K-MET™ Bioresorbable Bone screw

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female patients aged 20 years or older
• Patients who require internal fixation using screws in the hand
• The clinical features of hand fractures are oblique and spiral fractures
• Patients who voluntarily submitted a written informed consent and are willing to and able to follow the clinical study protocol.

You may not qualify if:

• Infections around the fracture site or soft-tissue injury greater than Grade III
• Fracture patterns such as open, transverse or comminuted fracture with greater than type II
• Fractures that require the use of wires, pins or plates for fixation
• Patients with re-fracture
• Patients with critical systemic diseases
• Patients with renal failure showing plasma creatinine level exceed 1.4 at the screening
• Pregnant, lactating women
• Patients who have a history of allergy to magnesium alloy
• Patients with presence of past illness or taking a drug that may affect bone union
• Patients who have participated in other clinical study and treated with medication or other medical device within past 3 months
• Patients who are judged not to be appropriate for study enrollment in the opinion of the investigator

Sponsors & Collaborators

• U&I Corporation: lead

Study Officials

• Gyeong-jin Han, professor

  Ajou Univ hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 15, 2015
• First Posted: May 28, 2015
• Study Start: July 1, 2013
• Primary Completion: November 1, 2014
• Study Completion: December 1, 2014
• Last Updated: September 15, 2015

Record last verified: 2015-05