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

This study is currently recruiting participants.

Verified by Haukeland University Hospital, February 2009

First Received: February 11, 2008 Last Updated: February 24, 2009 History of Changes

Sponsored by:	Haukeland University Hospital
Information provided by:	Haukeland University Hospital
ClinicalTrials.gov Identifier:	NCT00621088

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

MedlinePlus related topics: Fractures Hip Injuries and Disorders Hip Replacement

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Parallel Assignment
Official Title:	A Prospective Randomised Multicenter Study Comparing the Sliding Hip Screw and the Intertan Nail in Trochanteric and Subtrochanteric Femoral Fractures

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
Estimated Study Completion Date:	March 2010
Estimated Primary Completion Date:	March 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Intertan: Active Comparator	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

Contacts

Contact: Kjell Matre, MD	55975690 ext 0047	kjell.matre@helse-bergen.no
Contact: Jonas Fevang, MD, PhD	55975670 ext 0047	jmfe@helse-bergen.no

Locations

Norway
Orthopaedic dep, Haukeland University Hospital	Recruiting
Bergen, Norway, 5021
Contact: Kjell Matre, MD 55975690 ext 0047 kjell.matre@helse-bergen.no
Contact: Jonas Fevang, MD,PhD 55975670 ext 0047 jmfe@helse-bergen.no

Sponsors and Collaborators

Haukeland University Hospital

Investigators

Principal Investigator:

Kjell Matre, MD

Orthopaedic Department, Haukeland University Hospital

More Information

No publications provided

Responsible Party:	Department of Orthopaedics, Haukeland University Hospital ( Kjell Matre, MD, Head of Orthopaedic trauma, Haukeland University Hospital )
Study ID Numbers:	17972
Study First Received:	February 11, 2008
Last Updated:	February 24, 2009
ClinicalTrials.gov Identifier:	NCT00621088 History of Changes
Health Authority:	Norway:Social Science Data Services

Study placed in the following topic categories:

Hip Fractures
Femoral Fractures
Fractures, Bone

Wounds and Injuries
Disorders of Environmental Origin
Leg Injuries

Additional relevant MeSH terms:

Hip Fractures
Femoral Fractures
Fractures, Bone
Wounds and Injuries

Disorders of Environmental Origin
Leg Injuries
Hip Injuries

ClinicalTrials.gov processed this record on May 06, 2009