- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02246335
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
Status
Unknown
Conditions
Intervention / Treatment
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.
Sponsor
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- HOPE
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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-
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