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Intramedullary Fixation of Humerus Fractures

NCT ID: NCT01017289

Last Updated: 2009-11-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-12-31

Study Completion Date

2011-12-31

Brief Summary

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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

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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.

Conditions

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Humeral Fractures Pathological Fractures

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Quantum

In this single arm study, the Quantum nailing system will be used in all patients.

Group Type EXPERIMENTAL

Quantum

Intervention Type DEVICE

Treatment of humerus fracture (according to the mentioned indications) with the Quantum Intramedullary Nailing System.

Interventions

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Quantum

Treatment of humerus fracture (according to the mentioned indications) with the Quantum Intramedullary Nailing System.

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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N.M.B. Medical Applications Ltd

INDUSTRY

Sponsor Role lead

Responsible Party

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Rabin Medical Center

Principal Investigators

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Michael Berenstein, md

Role: PRINCIPAL_INVESTIGATOR

Rabin hospital

Locations

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Rabin Medical Center

Petah Tikva, , Israel

Site Status

Countries

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Israel

Central Contacts

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Michael Bernstein, Orthopedic

Role: CONTACT

Phone: +972 50 544 0966

Other Identifiers

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N.M.B. P Q REV I 03.09

Identifier Type: -

Identifier Source: org_study_id