Hemiarthroplasty Compared to Total Hip Arthroplasty for Displaced Femoral Neck Fractures in the Elderly-elderly (HOPE)
Primary Purpose
Femoral Neck Fractures
Status
Unknown status
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Cemented total hip arthroplasty
Cemented hemiarthroplasty
Sponsored by
About this trial
This is an interventional treatment trial for Femoral Neck Fractures
Eligibility Criteria
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
Sites / Locations
- Orthopaedic department, Danderyd Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Control group
Treatment group
Arm Description
Hemiarthroplasty
Total hip arthroplasty
Outcomes
Primary Outcome Measures
Harris hip score
The hip specific outcome score Harris hip score at 2 years will be the main outcome variable
Secondary Outcome Measures
EQ-5D
Health-related quality of life at 2 years
EQ-5D
Health-related quality of life at 4 years
EQ-5D
Health-related quality of life at 6 years
EQ-5D
Health-related quality of life at 10 years
Adverse events
All hip related adverse events at 2 years
Adverse events
All hip related adverse events at 4 years
Adverse events
All hip related adverse events at 6 years
Adverse events
All hip related adverse events at 10 years
Harris hip score
Harris hip score at 4 years
Harris hip score
Harris hip score at 6 years
Harris hip score
Harris hip score at 10 years
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02246335
Brief Title
Hemiarthroplasty Compared to Total Hip Arthroplasty for Displaced Femoral Neck Fractures in the Elderly-elderly
Acronym
HOPE
Official Title
Hemiarthroplasty Compared to Total Hip Arthroplasty for Displaced Femoral Neck Fractures in the Elderly-elderly. A Randomized Controlled Trial.
Study Type
Interventional
2. Study Status
Record Verification Date
August 2016
Overall Recruitment Status
Unknown status
Study Start Date
October 2009 (undefined)
Primary Completion Date
October 2016 (Anticipated)
Study Completion Date
October 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Danderyd Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Total Hip Arthroplasty is equal to or better than Hemiarthroplasty in the treatment of displaced femoral neck fractures in the elderly-elderly
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Femoral Neck Fractures
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
120 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
Hemiarthroplasty
Arm Title
Treatment group
Arm Type
Active Comparator
Arm Description
Total hip arthroplasty
Intervention Type
Device
Intervention Name(s)
Cemented total hip arthroplasty
Intervention Type
Device
Intervention Name(s)
Cemented hemiarthroplasty
Primary Outcome Measure Information:
Title
Harris hip score
Description
The hip specific outcome score Harris hip score at 2 years will be the main outcome variable
Time Frame
2 years
Secondary Outcome Measure Information:
Title
EQ-5D
Description
Health-related quality of life at 2 years
Time Frame
2 years
Title
EQ-5D
Description
Health-related quality of life at 4 years
Time Frame
4 years
Title
EQ-5D
Description
Health-related quality of life at 6 years
Time Frame
6 years
Title
EQ-5D
Description
Health-related quality of life at 10 years
Time Frame
10 years
Title
Adverse events
Description
All hip related adverse events at 2 years
Time Frame
2 years
Title
Adverse events
Description
All hip related adverse events at 4 years
Time Frame
4 years
Title
Adverse events
Description
All hip related adverse events at 6 years
Time Frame
6 years
Title
Adverse events
Description
All hip related adverse events at 10 years
Time Frame
10 years
Title
Harris hip score
Description
Harris hip score at 4 years
Time Frame
4 years
Title
Harris hip score
Description
Harris hip score at 6 years
Time Frame
6 years
Title
Harris hip score
Description
Harris hip score at 10 years
Time Frame
10 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Orthopaedic department, Danderyd Hospital
City
Stockholm
ZIP/Postal Code
18288
Country
Sweden
12. IPD Sharing Statement
Citations:
PubMed Identifier
26480938
Citation
Skoldenberg O, Chammout G, Mukka S, Muren O, Nasell H, Hedbeck CJ, Salemyr M. HOPE-trial: hemiarthroplasty compared to total hip arthroplasty for displaced femoral neck fractures in the elderly-elderly, a randomized controlled trial. BMC Musculoskelet Disord. 2015 Oct 19;16:307. doi: 10.1186/s12891-015-0763-3.
Results Reference
derived
Learn more about this trial
Hemiarthroplasty Compared to Total Hip Arthroplasty for Displaced Femoral Neck Fractures in the Elderly-elderly
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