Anterolateral Versus Posterolateral Approach to the Fractured Hip Arthroplasty (APAF)

July 31, 2017 updated by: Sundsvall Hospital

Anterolateral Versus Posterolateral Approach to the Fractured Hip Arthroplasty - a Change in Approach at Sundsvall Hospital.

The purpose of this study is to determine whether the anterolateral in comparison to posterolateral approach to the hip arthroplasty gives an equal or better clinical results.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The purpose of this study is to compare the anterolateral- to posterolateral approaches in patients suffering a displaced femoral neck fracture operated with an hip arthroplasty. Our hypothesis is that the anterolateral approach gives equal or better clinical function, health related quality of life and less complication and reoperations.

Study Type

Interventional

Enrollment (Anticipated)

160

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Sundsvall, Sweden, 851 86
        • Department of orthopedic surgery Sundsvall Hospital
    • Västernorrlands län
      • Sundsvall, Västernorrlands län, Sweden, 851 86
        • Sundsvall Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age > 65 years
  • Displaced femoral neck fracture

Exclusion Criteria:

  • Pathologic fracture
  • Not Swedish speaker
  • Not living in Västernorrlands county

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Anterolateral approach

Patients with a displaced femoral neck fracture operated through the anterolateral approach to the hip arthroplasty.

Lubinus total hip arthroplasty or varikopf hemiarthroplasty.
Procedure: Anterolateral approach
Anterolateral approach acording to Gammer for hip arthroplasty.
Other Names:
  • Anterolateral approach according to Gammer.
  • Lubinus total hip arthroplasty or varikopf hemiarthroplasty.
NO_INTERVENTION: Posterolateral approach

Patients with a displaced femoral neck fracture operated through the posterolateral approach to the hip arthroplasty.

Lubinus total hip arthroplasty or varikopf hemiarthroplasty.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Womac
Time Frame: 1 year postoperatively
1 year postoperatively

Secondary Outcome Measures

Outcome Measure
Time Frame
EQ5D
Time Frame: 1 year postoperatively
1 year postoperatively
Harris Hip Score
Time Frame: 1 year postoperatively
1 year postoperatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sundsvall Hospital

Investigators

  • Principal Investigator: Arkan S Sayed-Noor, Umeå University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2012

Primary Completion (ACTUAL)

June 1, 2015

Study Completion (ACTUAL)

June 1, 2015

Study Registration Dates

First Submitted

December 2, 2011

First Submitted That Met QC Criteria

December 5, 2011

First Posted (ESTIMATE)

December 6, 2011

Study Record Updates

Last Update Posted (ACTUAL)

August 2, 2017

Last Update Submitted That Met QC Criteria

July 31, 2017

Last Verified

April 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Sebastian-12

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Publication in an international peer-review journal.

IPD Sharing Time Frame

Publishing resultat in 2017

IPD Sharing Access Criteria

Open Access

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Femoral Neck Fracture

Clinical Trials on Anterolateral approach

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Ecuador

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe