Humeral FracturesNCT01087463
Intramedullary Fixation of Humerus Fractures Without Intramedullary Reaming
A study testing Quantum in people with Humeral Fractures and Pathological Fractures, run by N.M.B. Medical Applications Ltd at 1 site in Israel.
Trial summary
The purpose of the study is to evaluate the safety and efficacy of the composite Nail - the Quantum interlocking intramedullary nailing system in the reduction of humeral fractures. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Humeral Fractures, Pathological Fractures
- What is being tested?
- Quantum
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteIsrael
- Study dates
- Apr 2010to Apr 2012
- Phase
- Interventional
- 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 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Above 18 years old.
- Mid shaft diaphyseal fracture
- Acute fracture
Who cannot join
- Patients with metabolic or hormonal diseases that could affect bone healing such as diabetes.
- Ongoing infection in fracture site.
Trial locations and contacts
1 site in 1 country.
Israel1 site
Hilel Yafe Medical Center
Hadera, 38100
Gili Laufer, Orthopedic, +972503299680, michalla@netvision.net.il
Gili Laufer, Orthopedic
About this study
Official title: Composite Nailing System for the Intramedullary Fixation of Humerus Fractures Without Intramedullary Reaming
The purpose of the study is to evaluate the safety and efficacy of the composite Nail - the Quantum interlocking intramedullary nailing system in the reduction of humeral fractures.
Read the detailed description
The study will include 20 patients who have an acute mid shaft diaphyseal humeral fracture due to injury. The patients will undergo lateral and AP X- ray evaluation of the fracture. Following General anesthesia, closed reduction of the fracture will be performed. It will be followed by nail insertion, percutaneously, according to standard surgical techniques, with the help of the insertion handle and without preliminary reaming. Following insertion the nail will be locked both distally and proximally using interlocking screws. The nail and screws insertion will be monitored by fluoroscopy. Patients will remain under follow up for 6 months following the procedure. In the follow up sessions the fracture will be evaluated by fluoroscopy or X-ray for correct bone alignment, callus formation, and fracture union.
- Conditions
- Humeral Fractures, Pathological Fractures
- Being tested
- Quantum
- Medical subject headings
- Humeral Fractures, Fractures, Spontaneous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuantumDevice
Treatment of humerus fracture (according to the mentioned indications) with the Quantum Intramedullary Nailing System.
| Study group | Role | What they receive |
|---|---|---|
| single arm | Experimental | In this single arm study, the Quantum nailing system will be used in all patients. Receives: Device: Quantum |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bone union and callus formation,bone alignment, nail and screws resistance over time
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 posted16 Mar 2010 (estimated)
- Study startApr 2010
- Primary completionApr 2011 (estimated)
- Study completionApr 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Humeral 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- N.M.B. Medical Applications Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Gili Laufer, Orthopedic, Principal investigator, Hilel Yafe Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01087463
- Sponsor's protocol ID
- N.M.B. P_HY Q REV I 09.09
- Status last verified
- Feb 2010
- First submitted
- 14 Mar 2010
- Last updated
- 16 Mar 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Composite Nailing System for the Intramedullary Fixation of Humerus Fractures Without Intramedullary Reaming
- ClinicalTrials.gov ID
- NCT01087463
- Acronym / sponsor ID
- N.M.B. P_HY Q REV I 09.09
- Conditions
- Humeral Fractures, Pathological Fractures
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- N.M.B. Medical Applications LtdIndustry (pharma, biotech, devices)
- Study start
- Apr 2010
- Primary completion
- Apr 2011 (estimated)
- Study completion
- Apr 2012 (estimated)
- First posted
- 16 Mar 2010 (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.
The purpose of the study is to evaluate the safety and efficacy of the composite Nail - the Quantum interlocking intramedullary nailing system in the reduction of humeral fractures.
Detailed description
The study will include 20 patients who have an acute mid shaft diaphyseal humeral fracture due to injury. The patients will undergo lateral and AP X- ray evaluation of the fracture. Following General anesthesia, closed reduction of the fracture will be performed. It will be followed by nail insertion, percutaneously, according to standard surgical techniques, with the help of the insertion handle and without preliminary reaming. Following insertion the nail will be locked both distally and proximally using interlocking screws. The nail and screws insertion will be monitored by fluoroscopy. Patients will remain under follow up for 6 months following the procedure. In the follow up sessions the fracture will be evaluated by fluoroscopy or X-ray for correct bone alignment, callus formation, and fracture union.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| single arm | Experimental | Device: QuantumIn this single arm study, the Quantum nailing system will be used in all patients. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Above 18 years old.
- Mid shaft diaphyseal fracture
- Acute fracture
Key exclusion criteria (2 listed)
- Patients with metabolic or hormonal diseases that could affect bone healing such as diabetes.
- Ongoing infection in fracture site.
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 |
|---|---|---|
| QuantumTreatment of humerus fracture (according to the mentioned indications) with the Quantum Intramedullary Nailing System. | Device | single arm |
Primary outcome
Bone union and callus formation,bone alignment, nail and screws resistance over time
Time frame: up to 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2010.
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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.
Gili Laufer, Orthopedic principal investigator
Hilel Yafe Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Quantum in people with Humeral Fractures and Pathological Fractures, run by N.M.B. Medical Applications Ltd at 1 site in Israel.
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 3 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 16 Mar 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Gili Laufer, Orthopedic sergeon (+972503299680, michalla@netvision.net.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bone union and callus formation,bone alignment, nail and screws resistance over time (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 16 Mar 2010.