Prospective Randomized Comparison of Bipolar Hemiarthroplasty and Total Hip Arthroplasty With Large Femoral Heads for the Treatment of Displaced Intracapsular Femoral Neck Fractures in the Elderly

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

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-04-30

Study Completion Date

2013-12-31

Brief Summary

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The purpose of this study is to compare hemiarthroplasty (HAP) with total hip arthroplasty (THA), performed by trained arthroplasty surgeons with the use of large femoral heads for the treatment of displaced femoral neck fractures in mobile independent elderly patients, to determine the impact of these surgical options on the short term functional outcomes and complication rates, namely dislocation and the need for further surgery.

This is a single-blinded prospective randomized clinical trial comparing functional outcome and complication rates of 40 patients treated with all cemented THA to a control group of 40 patients treated with cemented bipolar HAP, in a 2 years followup.

The primary endpoint is the Oxford hip score (OHS) at last followup as a measure of functional outcome. Secondary endpoints include the SF-36 score, walking distance and rates of postoperative dislocation, component loosening, need for revision and postoperative mortality.

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Detailed Description

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Conditions

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Femoral Neck Fractures

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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THA

Total hip arthroplasty

Group Type EXPERIMENTAL

Total hip arthroplasty

Intervention Type PROCEDURE

All cemented THA

HAP

Bipolar Hemiarthroplasty

Group Type ACTIVE_COMPARATOR

Hemiarthroplasty

Intervention Type PROCEDURE

Cemented bipolar HAP

Interventions

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Total hip arthroplasty

All cemented THA

Intervention Type PROCEDURE

Hemiarthroplasty

Cemented bipolar HAP

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* 1\. Acute femoral neck fracture.
* 2\. Age between 70 and 90 years old.
* 3\. Independent community ambulator (more than 0.5km, without the aid of another person. The use of a cane is permitted) prior to fracture.
* 4\. Abbreviated mental test score \> 6 .

Exclusion Criteria

* 1\. Pathological fracture (excluding osteoporosis).
* 2\. Rheumatoid arthritis.
* 3\. Symptomatic arthrosis of the involved hip.
* 4\. Neurological disorder that may significantly influence walking ability and/or tendency to dislocate.
* 5\. Chronic corticosteroid use.
* 6\. Concomitant other fracture.
* 7\. Very high surgical risk.

Minimum Eligible Age

70 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No