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

Femoral Fractures Clinical Trial

— TSP  

Official title:

A Prospective Randomised Study of Unstable Trochanteric Femur Fractures Treated With Dynamic Hip Screw With and Without a Trochanter Support Plate

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00626470
• Other study ID #: TSP Study
• Status: Completed
• Phase: N/A
• First received: February 15, 2008
• Last updated: September 28, 2017
• Start date: December 2008
• Est. completion date: December 2014

Study information

• Verified date: September 2017
• Source: St. Olavs Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: December 2014
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Femoral Fractures
• Fractures, Bone

Intervention

Procedure:
• Addition of TSP to DHS
All patients operated with DHS. Of these two groups. One operated with TSP and one without.

Locations

Country	Name	City	State
Norway	Ortopaedic Department, St.Olavs Hospital	Trondheim

Sponsors (1)

Lead Sponsor	Collaborator
St. Olavs Hospital

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fracture movement postoperatively		One year
Secondary	Reoperation		One year
Secondary	Pain postoperatively		one year
Secondary	Hip function postoperatively		one year
Secondary	Fracture healing		one year
Secondary	complications postoperatively		one year