Anterolateral Watson Jones Approach Versus Transgluteal Approach for Uncemented Hemi- Arthroplasty in Displaced Femoral Neck Fracture

November 9, 2022 updated by: Sorlandet Hospital HF
Hemiarthroplasty is a well established treatment of Femoral Neck Fractures in the Elderly. During the last decade the use of Minimal Invasive Surgical( MIS) approaches have been increasing. Our hypothesis is that Patients with a Femoral Neck Fracture may benefit from a MIS approach.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The study's main objective: The purpose of the study is to test the following hypothesis. Patients 70 to 90 years with a displaced femoral neck fracture, operated with a hemiarthroplasty through an anterolateral approach, have less pain and better patient satisfaction as measured by PROMs than patients operated through the lateral approach.

The study's subsidiary objectives. We aim to shed light on the following subsidiary hypotheses.

  1. A hemiarthroplasty inserted through an anterolateral approach gives less bone resorption, as measured by DEXA around the stem, than a hemiarthroplasty inserted via a direct lateral approach.
  2. A hemiarthroplasty inserted through an anterolateral approach causes lesser degree of muscle damage, as measured by CK, than a direct lateral approach

Study Type

Interventional

Enrollment (Anticipated)

150

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

  • Norway
      • Kristiansand, Norway, 4604
        • Sorlandet 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

70 years to 90 years (Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria: Patients 70- 85 Years of Age -

Exclusion Criteria:

Dementia, Infection Not Suitable for Hemiarthroplasty

-

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Anterolateral Approach
Patient Operated with Watson Jones Approach
Procedure: hemiarthroplasty
Active Comparator: Trans-gluteal Approach
Patient operated with Trans-gluteal Hardinge Approach
Procedure: hemiarthroplasty

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Visual Analogue Scale Pain and Patient Satisfaction
Time Frame: Pre and postoperative, 3 and 12 Months
Pre and postoperative, 3 and 12 Months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Timed up and go
Time Frame: postoperative, 3 and 12 Monthes
TUG test- Timed up and Go
postoperative, 3 and 12 Monthes
Harris Hip Score
Time Frame: Pre / Postoperative, 3 and 12 Months
Pre / Postoperative, 3 and 12 Months
Hip Osteoarthritis Disability Score
Time Frame: Postoperative, 3 and 12 Months
Postoperative, 3 and 12 Months
EuroQol
Time Frame: Postoperative, 3 and 12 Months
Postoperative, 3 and 12 Months

Collaborators and Investigators

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

Sponsor

Sorlandet Hospital HF

Investigators

  • Principal Investigator: Lars Nordsletten, Professor, University of Oslo Ullevål

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, 2014

Primary Completion (Actual)

March 1, 2018

Study Completion (Actual)

March 11, 2022

Study Registration Dates

First Submitted

January 3, 2014

First Submitted That Met QC Criteria

January 3, 2014

First Posted (Estimate)

January 7, 2014

Study Record Updates

Last Update Posted (Actual)

November 10, 2022

Last Update Submitted That Met QC Criteria

November 9, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 811419

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.

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