Intramedullary Fixation of Humerus Fractures
Primary Purpose
Humeral Fractures, Pathological Fractures
Status
Unknown status
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Quantum
Sponsored by
About this trial
This is an interventional treatment trial for Humeral Fractures
Eligibility Criteria
Inclusion Criteria:
- Above 18 years old.
- Mid shaft diaphyseal fracture
- Acute fracture
Exclusion Criteria:
- Patients with metabolic or hormonal diseases that could affect bone healing such as diabetes.
- Ongoing infection in fracture site.
Sites / Locations
- Rabin Medical Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Quantum
Arm Description
In this single arm study, the Quantum nailing system will be used in all patients.
Outcomes
Primary Outcome Measures
Bone union and callus formation
Bone alignment
Nail and screws resistance over time
Secondary Outcome Measures
Full Information
NCT ID
NCT01017289
First Posted
November 19, 2009
Last Updated
November 19, 2009
Sponsor
N.M.B. Medical Applications Ltd
1. Study Identification
Unique Protocol Identification Number
NCT01017289
Brief Title
Intramedullary Fixation of Humerus Fractures
Official Title
A Study Evaluating the Quantum - Composite Nailing System for Intramedullary Fixation of Humerus Fractures
Study Type
Interventional
2. Study Status
Record Verification Date
November 2009
Overall Recruitment Status
Unknown status
Study Start Date
December 2009 (undefined)
Primary Completion Date
December 2010 (Anticipated)
Study Completion Date
December 2011 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
N.M.B. Medical Applications Ltd
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
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. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Humeral Fractures, Pathological Fractures
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Quantum
Arm Type
Experimental
Arm Description
In this single arm study, the Quantum nailing system will be used in all patients.
Intervention Type
Device
Intervention Name(s)
Quantum
Intervention Description
Treatment of humerus fracture (according to the mentioned indications) with the Quantum Intramedullary Nailing System.
Primary Outcome Measure Information:
Title
Bone union and callus formation
Time Frame
up to 6 months
Title
Bone alignment
Time Frame
up to 6 months
Title
Nail and screws resistance over time
Time Frame
up to 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Above 18 years old.
Mid shaft diaphyseal fracture
Acute fracture
Exclusion Criteria:
Patients with metabolic or hormonal diseases that could affect bone healing such as diabetes.
Ongoing infection in fracture site.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Michael Bernstein, Orthopedic
Phone
+972 50 544 0966
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Berenstein, md
Organizational Affiliation
Rabin hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rabin Medical Center
City
Petah Tikva
ZIP/Postal Code
49100
Country
Israel
12. IPD Sharing Statement
Learn more about this trial
Intramedullary Fixation of Humerus Fractures
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