NCT01087463

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2010

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 14, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 16, 2010

Completed
16 days until next milestone

Study Start

First participant enrolled

April 1, 2010

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2011

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2012

Completed
Last Updated

March 16, 2010

Status Verified

February 1, 2010

Enrollment Period

1 year

First QC Date

March 14, 2010

Last Update Submit

March 14, 2010

Conditions

Humeral FracturesPathological Fractures

Outcome Measures

Primary Outcomes (1)

  • Bone union and callus formation,bone alignment, nail and screws resistance over time

    up to 6 months

Study Arms (1)

single arm

EXPERIMENTAL

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

Device: Quantum

Interventions

QuantumDEVICE

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

single arm

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Above 18 years old.
  • Mid shaft diaphyseal fracture
  • Acute fracture

You may not qualify if:

  • Patients with metabolic or hormonal diseases that could affect bone healing such as diabetes.
  • Ongoing infection in fracture site.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hilel Yafe Medical Center

Hadera, 38100, Israel

Location

MeSH Terms

Conditions

Humeral FracturesFractures, Spontaneous

Condition Hierarchy (Ancestors)

Arm InjuriesWounds and InjuriesFractures, Bone

Study Officials

  • Gili Laufer, Orthopedic

    Hilel Yafe Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Gili Laufer, Orthopedic sergeon

CONTACT

+972503299680michalla@netvision.net.il

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

March 14, 2010

First Posted

March 16, 2010

Study Start

April 1, 2010

Primary Completion

April 1, 2011

Study Completion

April 1, 2012

Last Updated

March 16, 2010

Record last verified: 2010-02

Locations

IL(1)