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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
St. Olavs Hospital
ClinicalTrials.gov Identifier:
NCT00626470
First received: February 15, 2008
Last updated: August 18, 2014
Last verified: August 2014

February 15, 2008
August 18, 2014
December 2008
December 2013   (final data collection date for primary outcome measure)
Fracture movement postoperatively [ Time Frame: One year ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00626470 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Prospective Trial on Trochanteric Femur Fractures Treated With or Without a Trochanter Support Plate
A Prospective Randomised Study of Unstable Trochanteric Femur Fractures Treated With Dynamic Hip Screw With and Without a Trochanter Support Plate

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Femoral Fractures
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 without TSP
    Intervention: Procedure: Addition of TSP to DHS
  • Active Comparator: +TSP
    Patients operated with TSP
    Intervention: Procedure: Addition of TSP to DHS

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
100
December 2014
December 2013   (final data collection date for primary outcome measure)

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.
Both
19 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Norway
 
NCT00626470
TSP Study
No
St. Olavs Hospital
St. Olavs Hospital
Not Provided
Principal Investigator: James Haddon, MD St. Olavs Hospital
St. Olavs Hospital
August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP