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A Prospective Randomised Multicenter Study Comparing the Sliding Hip Screw and the Intertan Nail in Trochanteric and Subtrochanteric Femoral Fractures

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00621088
First Posted: February 22, 2008
Last Update Posted: September 14, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Haukeland University Hospital
  Purpose

This is a study to compare the new nail "INTERTAN" with a Sliding Hip Screw in treating a specific group of hipfractures (trochanteric and subtrochanteric fractures).

Are there differences in terms of pain, early and late functional mobility and complications between the to implants (and methods of operation)?


Condition Intervention
Trochanteric and Subtrochanteric Hip Fractures Treatment With a New Nail or a Sliding Hip Screw Procedure: Intertan

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective Randomised Multicenter Study Comparing the Sliding Hip Screw and the Intertan Nail in Trochanteric and Subtrochanteric Femoral Fractures

Resource links provided by NLM:


Further study details as provided by Haukeland University Hospital:

Primary Outcome Measures:
  • Early postoperative pain (VAS)(and functional mobility (TUG-test)) [ Time Frame: 1 week postoperative ]

Secondary Outcome Measures:
  • Pain, functional mobility (TUG-test), Harris Hip Score, quality of life (EQ-5D) and complications at discharge from hospital,and at 6 weeks,3 and 12 months postop. [ Time Frame: 1 year follow up ]

Estimated Enrollment: 500
Study Start Date: February 2008
Study Completion Date: March 2010
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Intertan Procedure: Intertan
Operations performed either with a Sliding Hip Screw or a nail (Intertan)

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients older than 60 years with a trochanteric or subtrochanteric hip fracture.

Exclusion Criteria:

  • Patients with pathologic fractures, patients already included with a fracture on the opposite side.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00621088


Locations
Norway
Orthopaedic dep, Haukeland University Hospital
Bergen, Norway, 5021
Sponsors and Collaborators
Haukeland University Hospital
Investigators
Principal Investigator: Kjell Matre, MD Orthopaedic Department, Haukeland University Hospital
  More Information

Responsible Party: Kjell Matre, MD, Head of Orthopaedic trauma, Haukeland University Hospital, Department of Orthopaedics, Haukeland University Hospital
ClinicalTrials.gov Identifier: NCT00621088     History of Changes
Other Study ID Numbers: 17972
First Submitted: February 11, 2008
First Posted: February 22, 2008
Last Update Posted: September 14, 2010
Last Verified: September 2010

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