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Prospective Trial on Trochanteric Femur Fractures Treated With or Without a Trochanter Support Plate (TSP)

This study is currently recruiting participants.
Verified August 2012 by St. Olavs Hospital
Sponsor:
Information provided by (Responsible Party):
St. Olavs Hospital
ClinicalTrials.gov Identifier:
NCT00626470
First received: February 15, 2008
Last updated: August 1, 2012
Last verified: August 2012
History of Changes
  Purpose

Fractures just below the hip often are treated with a so called Gliding Screw and Plate (DHS). Recently a new additional plate called a Trochanter Support Plate (TSP) which attaches to the DHS has become available which is claimed to give extra support to the fracture. In a prospective randomised study we wish to test the hypothesis that the TSP does not give any additional stability to the fracture treated with the DHS.


Condition Intervention
Femoral Fractures
 Procedure: Addition of TSP to DHS

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Prospective Randomised Study of Unstable Trochanteric Femur Fractures Treated With Dynamic Hip Screw With and Without a Trochanter Support Plate

Resource links provided by NLM:

MedlinePlus related topics: Fractures
U.S. FDA Resources

Further study details as provided by St. Olavs Hospital:

Primary Outcome Measures:
  • Fracture movement postoperatively [ Time Frame: One year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Reoperation [ Time Frame: One year ] [ Designated as safety issue: Yes ]
  • Pain postoperatively [ Time Frame: one year ] [ Designated as safety issue: No ]
  • Hip function postoperatively [ Time Frame: one year ] [ Designated as safety issue: No ]
  • Fracture healing [ Time Frame: one year ] [ Designated as safety issue: Yes ]
  • complications postoperatively [ Time Frame: one year ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 100
Study Start Date: December 2008
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: -TSP
Patients operated without TSP
 Procedure: Addition of TSP to DHS
All patients operated with DHS. Of these two groups. One operated with TSP and one without.
Active Comparator: +TSP
Patients operated with TSP
 Procedure: Addition of TSP to DHS
All patients operated with DHS. Of these two groups. One operated with TSP and one without.

  Eligibility

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Clinical diagnosis of unstable trochanteric femur fracture.(Evans-Jensen class.3-5)
  • (can include; Patients with cognitive problems (ie. dementia etc)

Exclusion Criteria:

  • Patients with pathological fractures
  • Multitrauma patients
  • Patients not able to walk before the fracture
  • Under 19 years old.
  • Patients with fractures needing other treatments than gliding hip screws
  • Reverse oblique fractures.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00626470

Contacts
Contact: James WA Haddon, MD 06800 ext 3732 james.haddon@stolav.no
Contact: Robert Buciuto, PhD robert.buciuto@stolav.no

Locations
Norway
Ortopaedic Department, St.Olavs Hospital Recruiting
Trondheim, Norway, 7000
Contact: James Haddon, MD         james.haddon@stolav.no    
Principal Investigator: James Haddon, MD            
Sponsors and Collaborators
St. Olavs Hospital
Investigators
Principal Investigator: James Haddon, MD St. Olavs Hospital
  More Information

Publications:

Responsible Party: St. Olavs Hospital
ClinicalTrials.gov Identifier: NCT00626470     History of Changes
Other Study ID Numbers: TSP Study
Study First Received: February 15, 2008
Last Updated: August 1, 2012
Health Authority: Norway:National Committee for Medical and Health Research Ethics

Keywords provided by St. Olavs Hospital:
Trochanter
Femur
Fracture

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

ClinicalTrials.gov processed this record on May 16, 2013