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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:
Information provided by:
Haukeland University Hospital
ClinicalTrials.gov Identifier:
NCT00621088
First received: February 11, 2008
Last updated: September 12, 2010
Last verified: September 2010
History of Changes
  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: 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:

U.S. FDA Resources

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 ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   60 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: February 11, 2008
Last Updated: September 12, 2010
Health Authority: Norway:Social Science Data Services

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

ClinicalTrials.gov processed this record on June 18, 2013