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Intramedullary Fixation of Humerus Fractures Without Intramedullary Reaming

Primary Purpose

Humeral Fractures, Pathological Fractures

Status
Unknown status
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Quantum
Sponsored by
N.M.B. Medical Applications Ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Humeral Fractures

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

  • Hilel Yafe Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

single arm

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

First Posted
March 14, 2010
Last Updated
March 14, 2010
Sponsor
N.M.B. Medical Applications Ltd
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1. Study Identification

Unique Protocol Identification Number
NCT01087463
Brief Title
Intramedullary Fixation of Humerus Fractures Without Intramedullary Reaming
Official Title
Composite Nailing System for the Intramedullary Fixation of Humerus Fractures Without Intramedullary Reaming
Study Type
Interventional

2. Study Status

Record Verification Date
February 2010
Overall Recruitment Status
Unknown status
Study Start Date
April 2010 (undefined)
Primary Completion Date
April 2011 (Anticipated)
Study Completion Date
April 2012 (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 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.

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
single arm
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,bone alignment, 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
Gili Laufer, Orthopedic sergeon
Phone
+972503299680
Email
michalla@netvision.net.il
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gili Laufer, Orthopedic
Organizational Affiliation
Hilel Yafe Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hilel Yafe Medical Center
City
Hadera
ZIP/Postal Code
38100
Country
Israel
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gili Laufer, Orthopedic
Phone
+972503299680
Email
michalla@netvision.net.il
First Name & Middle Initial & Last Name & Degree
Gili Laufer, Orthopedic

12. IPD Sharing Statement

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Intramedullary Fixation of Humerus Fractures Without Intramedullary Reaming

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