Clinical trial NCT02456415: The Efficacy and Safety of Magnesium Alloy Screw as a Novel Bioabsorbable Material in Patients Due to Hand Fractures
Official title: A Prospective, Single Center, Single Group, Open-label Study to Evaluate the Efficacy and Safety of Magnesium Alloy Screw as a Novel Bioabsorbable Material in Patients Requiring Internal Fixation Due to Hand Fractures
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hand Fractures
Lead sponsor: U&I Corporation
Sponsor class: OTHER
First posted: 2015-05-28
Enrollment: 28
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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)).

Detailed description: Rationale: Hand fractures including intra- and extra-articular phalanges and metacarpal are common and account for approximately 40% of upper extremity fractures and lead to functional loss of the hand.Fractures can be treated conservatively with a nonsurgical approach(Closed reduction) by placing the damaged figure in a splint; this may results in displacement, rotation, angulation and/or instability, therefore require surgery. Surgical techniques for treatment of hand fractures include internal fixation with metal plate or screws after Open reduction and external fixation with insertion of percutaneous pins or screws. Percutaneous external fixation is one of the widely used methods, but is difficult to maintained when accompanied by unstable fractures and soft tissue injuries or there are severely comminuted fractures and sometimes results in restricted motion of adjacent joints due to prolonged fixation. In comparison, internal fixation is an operation using internal fixators such as plates, wires, screws etc. solely or concurrently depending on the location and severity of hand fracture. With the recent advancement of implant design and fixation techniques, a variety of screws are widely used for fixation of small-bone fractures.

The present study was designed to evaluate the efficacy and safety of magnesium alloy screw as a novel bioabsorbable and biodegradable material.

Study Duration: After an approval of clinical protocol from MFDS in Korea, total 20 months were required including 14 months for subject enrollment and 6 months of follow-up. An additional 1 month was required after completion of the study for handling of data, statistical analysis and preparation of study report.

Target Subjects: Patients who require internal fixation using screws due to hand fractures

Investigational Device: K-MET™ Bioresorbable Bone screw (manufactured by U\&I) This device divided into two type,Cortex screw and Headless compression screw.

Number of Subjects: A total of 34 cases of bone fractures in 28 subjects.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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

Primary outcomes:
measure: Bone union
timeFrame: up to 6 months
Secondary outcomes:
measure: PROM(Passive Range of Motion)
timeFrame: up to 6 months
measure: TAM(Total Active Motion)
timeFrame: up to 6 months
measure: Power(grip strength and pick-up power)
timeFrame: up to 6 months
measure: DASH scale
timeFrame: 3,6 months
measure: Pain as measured by the NRS (1~10)
timeFrame: up to 6 months
Other outcomes:
Locations:
Study officials:
affiliation: Ajou Univ hospital
name: Gyeong-jin Han, professor
role: PRINCIPAL_INVESTIGATOR
References: