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Direct Anterior Approach Versus Mini Posterior Approach Versous Lateral Approach for Displaced Femoral Neck Fractures

NCT ID: NCT04618549

Last Updated: 2020-11-06

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

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-11-01

Study Completion Date

2022-03-30

Brief Summary

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In general, hip fractures in the elderly are associated with a high one year-mortality up to 36 %. Apart from choosing the proper treatment, optimizing the surgical technique itself offers options to improve the outcome. Early mobilization after hip hemi¬arthroplasty correlates with improved ambulation, reduced need for assisted transfers, and less use of extended care facilities after hospital discharge.

Nowadays, in order to reduce soft tissue damage and gain quicker postoperative recovery and faster rehabilitation, various MIS techniques have been proposed. Two of these techniques are the mini posterior approach and the mini direct anterior approach. The direct anterior approach was developed as a true internervous and intermuscular surgical approach with proposed benefits of faster recovery, quicker return to function, and less pain. In theory, the direct anterior approach should cause less tissue damage than mini posterior approach, as it is performed through a plane between neurlogical tissue and intermuscular plane without muscle transection.

The aim of this study is to evaluate the clinical and radiological outcomes of the direct anterior approach for bipolar head endoprosthetic hemiarthroplasty in patients with displaced femoral neck fractures in comparison with the mini posterior approach and the traditional lateral approach, for the treatment of the same fractures. The investigators hypothesized that patients undergoing the direct anterior approach would have better clinical and radiological results in comparison with the mini posterior and lateral approach.

Detailed Description

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Conditions

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Hip Fractures Femoral Neck Fractures

Keywords

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hip fractures surgical approach outcome bleeding

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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Direct anterior approach

Patients with a femoral neck fracture, treated by hemiarthroplasty by direct anterior approach, using a regular OR table, without hip hyperextension.

Group Type ACTIVE_COMPARATOR

Direct Anterior Approach Hemiarthroplasty

Intervention Type PROCEDURE

Hemiarthroplasty to elderly patients with femoral neck fracture through a direct anterior approach

Mini Posterior Approach

Patients with a femoral neck fracture, treated by hemiarthroplasty by a mini posterior approach.

Group Type ACTIVE_COMPARATOR

Mini Posterior Approach

Intervention Type PROCEDURE

Hemiarthroplasty to elderly patients with femoral neck fracture through a mini posterior approach

Lateral approach

Patients with a femoral neck fracture, treated by hemiarthroplasty by a lateral (Hardinge) approach.

Group Type ACTIVE_COMPARATOR

Lateral approach

Intervention Type PROCEDURE

Hemiarthroplasty to elderly patients with femoral neck fracture through a lateral approach (Hardinge)

Interventions

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Direct Anterior Approach Hemiarthroplasty

Hemiarthroplasty to elderly patients with femoral neck fracture through a direct anterior approach

Intervention Type PROCEDURE

Mini Posterior Approach

Hemiarthroplasty to elderly patients with femoral neck fracture through a mini posterior approach

Intervention Type PROCEDURE

Lateral approach

Hemiarthroplasty to elderly patients with femoral neck fracture through a lateral approach (Hardinge)

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Consecutive patients undergoing hip fracture surgery for displaced femoral neck fractures (Garden 3 and 4 fractures) and treated by cemented hemiarthroplasty will be included in the study. Patients must have the ability to give informed consent or a legal guardian is available.
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National and Kapodistrian University of Athens

OTHER

Sponsor Role lead

Responsible Party

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Vasileios S. Nikolaou

Associate Professor of Orthopaedics

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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Vasileios S Nikolaou, MD, PhD, MSc

Role: CONTACT

Phone: +306932543400

Email: [email protected]

Other Identifiers

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5

Identifier Type: -

Identifier Source: org_study_id