Comparison Between Gamma 3 Nail and ACE Trochanteric Nail

This study is currently recruiting participants. (see Contacts and Locations)
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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
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 October 19, 2014