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

NCT ID: NCT00626470

Last Updated: 2017-10-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-12-31

Study Completion Date

2014-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Femoral Fractures

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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-TSP

Patients operated without TSP

Group Type ACTIVE_COMPARATOR

Addition of TSP to DHS

Intervention Type PROCEDURE

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

+TSP

Patients operated with TSP

Group Type ACTIVE_COMPARATOR

Addition of TSP to DHS

Intervention Type PROCEDURE

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

Interventions

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Addition of TSP to DHS

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

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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St. Olavs Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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James Haddon, MD

Role: PRINCIPAL_INVESTIGATOR

St. Olavs Hospital

Locations

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Ortopaedic Department, St.Olavs Hospital

Trondheim, , Norway

Site Status

Countries

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Norway

Other Identifiers

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TSP Study

Identifier Type: -

Identifier Source: org_study_id