Hand FracturesPhase 2NCT02456415
The Efficacy and Safety of Magnesium Alloy Screw as a Novel Bioabsorbable Material in Patients Due to Hand Fractures
A Phase 2 study testing K-MET™ Bioresorbable Bone screw in people with Hand Fractures, run by U&I Corporation.
Trial 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)). Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hand Fractures
- What is being tested?
- K-MET™ Bioresorbable Bone screw
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- No sites listed yet
- Study dates
- Jul 2013to Dec 2014
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
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- 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
About this study
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
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)).
Read the 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.
- Conditions
- Hand Fractures
- Being tested
- K-MET™ Bioresorbable Bone screw
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
K-MET™ Bioresorbable Bone screwDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: K-MET™ Bioresorbable Bone screw |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: up to 6 months
Secondary outcomes (5)
PROM(Passive Range of Motion)
This Passive Range of Motion(PROM) is measured by goniometer and is compared with the value of the normal hand that did not undergo surgery.
Measured: up to 6 months
TAM(Total Active Motion)
Total Active Motion(TAM) is measured by goniometer and is compared with the value of the normal hand that did not undergo surgery.
Measured: up to 6 months
Power(grip strength and pick-up power)
The Power was measured using a dynamometer and pick-up counter and is compared with the value of the hand that did not undergo surgery.
Measured: up to 6 months
DASH scale
This questionnaire evaluates the ability of the hand to perform certain activities before and after surgery. It was directly completed by subjects.
Measured: 3,6 months
Pain as measured by the NRS (1~10)
The NRS (1~10) was used to measure the level of pain and was compared before and after surgery.
Measured: up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2015 (estimated)
- Study startJul 2013
- Primary completionNov 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hand FracturesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- U&I Corporation
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gyeong-jin Han, professor, Principal investigator, Ajou Univ hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02456415
- Sponsor's protocol ID
- UNI-01
- Status last verified
- May 2015
- First submitted
- 15 May 2015
- Last updated
- 15 Sep 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02456415
- Acronym / sponsor ID
- UNI-01
- Conditions
- Hand Fractures
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- U&I CorporationUniversity, hospital or other
- Study start
- Jul 2013
- Primary completion
- Nov 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 28 May 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| K-MET™ Bioresorbable Bone screw | Experimental | Device: K-MET™ Bioresorbable Bone screwThe 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. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| K-MET™ Bioresorbable Bone screwThe 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. | Device | K-MET™ Bioresorbable Bone screw |
Primary outcome
Bone union
Time frame: up to 6 months
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.
5 secondary outcomes
PROM(Passive Range of Motion)
Time frame: up to 6 months
TAM(Total Active Motion)
Time frame: up to 6 months
Power(grip strength and pick-up power)
Time frame: up to 6 months
DASH scale
Time frame: 3,6 months
Pain as measured by the NRS (1~10)
Time frame: up to 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gyeong-jin Han, professor principal investigator
Ajou Univ hospital
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing K-MET™ Bioresorbable Bone screw in people with Hand Fractures, run by U&I Corporation.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bone union (time frame: up to 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2015.