NCT01017289

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 Dec 2009

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

November 19, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 20, 2009

Completed
11 days until next milestone

Study Start

First participant enrolled

December 1, 2009

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
Last Updated

November 20, 2009

Status Verified

November 1, 2009

Enrollment Period

1 year

First QC Date

November 19, 2009

Last Update Submit

November 19, 2009

Conditions

Humeral FracturesPathological Fractures

Outcome Measures

Primary Outcomes (3)

  • Bone union and callus formation

    up to 6 months

  • Bone alignment

    up to 6 months

  • Nail and screws resistance over time

    up to 6 months

Study Arms (1)

Quantum

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.

Quantum

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)

Rabin Medical Center

Petah Tikva, 49100, Israel

Location

MeSH Terms

Conditions

Humeral FracturesFractures, Spontaneous

Condition Hierarchy (Ancestors)

Arm InjuriesWounds and InjuriesFractures, Bone

Study Officials

  • Michael Berenstein, md

    Rabin hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Michael Bernstein, Orthopedic

CONTACT

+972 50 544 0966

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

November 19, 2009

First Posted

November 20, 2009

Study Start

December 1, 2009

Primary Completion

December 1, 2010

Study Completion

December 1, 2011

Last Updated

November 20, 2009

Record last verified: 2009-11

Locations

IL(1)