Hemiarthroplasty Compared to Total Hip Arthroplasty for Displaced Femoral Neck Fractures in the Elderly-elderly (HOPE)

August 29, 2016 updated by: Olof Skoldenberg, Danderyd Hospital

Hemiarthroplasty Compared to Total Hip Arthroplasty for Displaced Femoral Neck Fractures in the Elderly-elderly. A Randomized Controlled Trial.

Total Hip Arthroplasty is equal to or better than Hemiarthroplasty in the treatment of displaced femoral neck fractures in the elderly-elderly

Study Overview

Detailed Description

Total Hip Arthroplasty is equal to or better alternative to Hemiarthroplasty in the treatment of displaced femoral neck fractures in the elderly-elderly (patients 80 years and over).

Study Type

Interventional

Enrollment (Actual)

120

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

      • Stockholm, Sweden, 18288
        • Orthopaedic department, Danderyd 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

80 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Acute displaced femoral neck fracture of hip (Garden classification 3-4)
  • Independent walker with or without walking aides
  • Patient willing to participate in the study and give written consent.

Exclusion Criteria:

  • Fracture older than 36 hours before admission
  • Osteoarthritis in the fractured hip
  • Rheumatoid arthritis in the fractured hip
  • Pathological fractures
  • Contraindication for hip arthroplasty surgery
  • Not suitable for inclusion for other reasons e.g. substance abuse

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: Control group
Hemiarthroplasty
Active Comparator: Treatment group
Total hip arthroplasty

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Harris hip score
Time Frame: 2 years
The hip specific outcome score Harris hip score at 2 years will be the main outcome variable
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
EQ-5D
Time Frame: 2 years
Health-related quality of life at 2 years
2 years
EQ-5D
Time Frame: 4 years
Health-related quality of life at 4 years
4 years
EQ-5D
Time Frame: 6 years
Health-related quality of life at 6 years
6 years
EQ-5D
Time Frame: 10 years
Health-related quality of life at 10 years
10 years
Adverse events
Time Frame: 2 years
All hip related adverse events at 2 years
2 years
Adverse events
Time Frame: 4 years
All hip related adverse events at 4 years
4 years
Adverse events
Time Frame: 6 years
All hip related adverse events at 6 years
6 years
Adverse events
Time Frame: 10 years
All hip related adverse events at 10 years
10 years
Harris hip score
Time Frame: 4 years
Harris hip score at 4 years
4 years
Harris hip score
Time Frame: 6 years
Harris hip score at 6 years
6 years
Harris hip score
Time Frame: 10 years
Harris hip score at 10 years
10 years

Collaborators and Investigators

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

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.

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

October 1, 2009

Primary Completion (Anticipated)

October 1, 2016

Study Completion (Anticipated)

October 1, 2020

Study Registration Dates

First Submitted

September 18, 2014

First Submitted That Met QC Criteria

September 19, 2014

First Posted (Estimate)

September 22, 2014

Study Record Updates

Last Update Posted (Estimate)

August 30, 2016

Last Update Submitted That Met QC Criteria

August 29, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

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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