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

September 28, 2017 updated by: St. Olavs Hospital

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
      • Trondheim, Norway, 7000
        • Ortopaedic Department, St.Olavs Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Fracture movement postoperatively
Time Frame: One year
One year

Secondary Outcome Measures

Outcome Measure
Time Frame
Reoperation
Time Frame: One year
One year
Pain postoperatively
Time Frame: one year
one year
Hip function postoperatively
Time Frame: one year
one year
Fracture healing
Time Frame: one year
one year
complications postoperatively
Time Frame: one year
one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

St. Olavs Hospital

Investigators

  • Principal Investigator: James Haddon, MD, St. Olavs Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

December 1, 2008

Primary Completion (ACTUAL)

December 1, 2013

Study Completion (ACTUAL)

December 1, 2014

Study Registration Dates

First Submitted

February 15, 2008

First Submitted That Met QC Criteria

February 28, 2008

First Posted (ESTIMATE)

February 29, 2008

Study Record Updates

Last Update Posted (ACTUAL)

October 2, 2017

Last Update Submitted That Met QC Criteria

September 28, 2017

Last Verified

September 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TSP Study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Femoral Fractures

Clinical Trials on Addition of TSP to DHS

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Egypt

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe