Text Size

Comparison Between Gamma 3 Nail and ACE Trochanteric Nail

This study is currently recruiting participants.
Verified January 2013 by University Hospital, Ghent
Sponsor:
Information provided by (Responsible Party):
University Hospital, Ghent
ClinicalTrials.gov Identifier:
NCT00367406
First received: August 21, 2006
Last updated: January 29, 2013
Last verified: January 2013
History of Changes
  Purpose

Pertrochanteric and subtrochanteric femur fractures will be treated with a Gamma 3 nail or an ACE Trochanteric nail.

Following topics will be assessed: fracture consolidation, mobility, pain, walking power, agility.


Condition Intervention
Pertrochanteric and Subtrochanteric Femur Fractures
 Device: Gamma 3 nail versus ACE trochanteric nail

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Comparison Between Gamma 3 Nail and ACE Trochanteric Nail

Resource links provided by NLM:

MedlinePlus related topics: Fractures
U.S. FDA Resources

Further study details as provided by University Hospital, Ghent:

Primary Outcome Measures:
  • Consolidation of the fracture [ Time Frame: From surgery untill healing ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: November 2006
Estimated Study Completion Date: July 2013
Estimated Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment with a Gamma 3 nail. Device: Gamma 3 nail versus ACE trochanteric nail
Comparing Gamma 3 nail versus ACE trochanteric nail

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Pertrochanteric or subtrochanteric femur fracture
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00367406

Contacts
Contact: René Verdonk, MD, PhD + 32 9 332.22.64 rene.verdonk@ugent.be

Locations
Belgium
University Hospital Ghent Recruiting
Ghent, Belgium, 9000
Contact: René Verdonk, MD, PhD     + 32 9 332.22.64     rene.verdonk@ugent.be    
Principal Investigator: René Verdonk, MD, PhD            
Sponsors and Collaborators
University Hospital, Ghent
Investigators
Principal Investigator: René Verdonk, MD, PhD University Hospital, Ghent
  More Information

Additional Information:
Website University Hospital Ghent  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: University Hospital, Ghent
ClinicalTrials.gov Identifier: NCT00367406     History of Changes
Other Study ID Numbers: 2006/280
Study First Received: August 21, 2006
Last Updated: January 29, 2013
Health Authority: Belgium: Institutional Review Board

Additional relevant MeSH terms:
Femoral Fractures
Fractures, Bone
Wounds and Injuries
Leg Injuries

ClinicalTrials.gov processed this record on May 23, 2013