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

Primary Purpose

Femoral Fractures

Status

Completed

Phase

Not Applicable

Locations

Norway

Study Type

Interventional

Intervention

Addition of TSP to DHS

About this trial

This is an interventional treatment trial for Femoral Fractures focused on measuring Trochanter, Femur, Fracture

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Ortopaedic Department, St.Olavs Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

-TSP

+TSP

Arm Description

Patients operated without TSP

Patients operated with TSP

Outcomes

Primary Outcome Measures

Fracture movement postoperatively

Secondary Outcome Measures

Reoperation

Pain postoperatively

Hip function postoperatively

Fracture healing

complications postoperatively

Full Information

NCT ID

NCT00626470

First Posted

February 15, 2008

Last Updated

September 28, 2017

Sponsor

St. Olavs Hospital

1. Study Identification

Unique Protocol Identification Number

NCT00626470

Brief Title

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

Acronym

TSP

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2017

Overall Recruitment Status

Completed

Study Start Date

December 2008 (Actual)

Primary Completion Date

December 2013 (Actual)

Study Completion Date

December 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

St. Olavs Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Femoral Fractures

Keywords

Trochanter, Femur, Fracture

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

100 (Actual)

8. Arms, Groups, and Interventions

Arm Title

-TSP

Arm Type

Active Comparator

Arm Description

Patients operated without TSP

Arm Title

+TSP

Arm Type

Active Comparator

Arm Description

Patients operated with TSP

Intervention Type

Procedure

Intervention Name(s)

Addition of TSP to DHS

Intervention Description

All patients operated with DHS. Of these two groups. One operated with TSP and one without.

Primary Outcome Measure Information:

Title

Fracture movement postoperatively

Time Frame

One year

Secondary Outcome Measure Information:

Title

Reoperation

Time Frame

One year

Title

Pain postoperatively

Time Frame

one year

Title

Hip function postoperatively

Time Frame

one year

Title

Fracture healing

Time Frame

one year

Title

complications postoperatively

Time Frame

one year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

19 Years

Accepts Healthy Volunteers

Eligibility 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

James Haddon, MD

Organizational Affiliation

St. Olavs Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Ortopaedic Department, St.Olavs Hospital

City

Trondheim

ZIP/Postal Code

7000

Country

Norway

12. IPD Sharing Statement

Learn more about this trial

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

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