Total Hip Arthroplasty Compared to Internal Fixation for Displaced Intracapsular Fractures of the Femoral Neck

NCT ID: NCT01344772

Last Updated: 2012-11-27

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

1990-02-28

Study Completion Date

2011-06-30

Brief Summary

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The primary aim of this study was to determine the Harris hip score as an evaluation of hip function, in mentally competent elderly patients (\>65 years old) treated with either THR or IF, after contracting a displaced femoral neck fracture. The secondary aim was to compare the rate of reoperations and complications between the two groups.

Detailed Description

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Conditions

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Femoral Neck Fracture

Keywords

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femoral neck fracture total hip arthroplasty internal fixation

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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Internal fixation

Displaced femoral neck fracture treated with internal fixation using two parallel cannulated screws.

Group Type ACTIVE_COMPARATOR

Internal fixation

Intervention Type PROCEDURE

Two cannulated screws are placed under x-ray guidance

Total hip replacement

Displaced femoral neck fracture treated with total hip replacement through a posterior approach.

Group Type ACTIVE_COMPARATOR

Total hip arthroplasty

Intervention Type PROCEDURE

A total hip arthroplasty is performed through a standard posterior approach

Interventions

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Internal fixation

Two cannulated screws are placed under x-ray guidance

Intervention Type PROCEDURE

Total hip arthroplasty

A total hip arthroplasty is performed through a standard posterior approach

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Acute displaced femoral neck fracture Garden III or IV,
* Age over 65 years,
* Admission from their own home,
* No concurrent joint disease or previous fracture in the lower extremities,
* Healthy or controlled medical conditions without significant systemic effects (ASA 1-2),
* Harris hip score of 100
* Acceptance from the patient to participate in the study.
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Danderyd Hospital

OTHER

Sponsor Role lead

Responsible Party

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Olof Skoldenberg

Consulatant Orthopaedic Surgeon, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Olof Sköldenberg, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Danderyd Hospital

Locations

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Danderyd Hospital

Stockholm, , Sweden

Site Status

Countries

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Sweden

Other Identifiers

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19902010

Identifier Type: -

Identifier Source: org_study_id