Prospective Randomized Comparison of Bipolar Hemiarthroplasty and Total Hip Arthroplasty With Large Femoral Heads for the Treatment of Displaced Intracapsular Femoral Neck Fractures in the Elderly
Primary Purpose
Femoral Neck Fractures
Status
Unknown status
Phase
Phase 1
Locations
Israel
Study Type
Interventional
Intervention
Total hip arthroplasty
Hemiarthroplasty
Sponsored by
About this trial
This is an interventional treatment trial for Femoral Neck Fractures focused on measuring Femoral neck fractures, Hip fractures, Elderly, Total hip arthroplasty, Bipolar hemiarthroplasty
Eligibility Criteria
Inclusion Criteria:
- 1. Acute femoral neck fracture.
- 2. Age between 70 and 90 years old.
- 3. Independent community ambulator (more than 0.5km, without the aid of another person. The use of a cane is permitted) prior to fracture.
- 4. Abbreviated mental test score > 6 .
Exclusion Criteria:
- 1. Pathological fracture (excluding osteoporosis).
- 2. Rheumatoid arthritis.
- 3. Symptomatic arthrosis of the involved hip.
- 4. Neurological disorder that may significantly influence walking ability and/or tendency to dislocate.
- 5. Chronic corticosteroid use.
- 6. Concomitant other fracture.
- 7. Very high surgical risk.
Sites / Locations
- Orthopaedic dept., E. Wolfson Medical centerRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
THA
HAP
Arm Description
Total hip arthroplasty
Bipolar Hemiarthroplasty
Outcomes
Primary Outcome Measures
Oxford hip score (OHS)
Secondary Outcome Measures
SF-36 score, walking distance
dislocation rate, mortality rate
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01109862
Brief Title
Prospective Randomized Comparison of Bipolar Hemiarthroplasty and Total Hip Arthroplasty With Large Femoral Heads for the Treatment of Displaced Intracapsular Femoral Neck Fractures in the Elderly
Official Title
Prospective Randomized Comparison of Bipolar Hemiarthroplasty and Total Hip Arthroplasty With Large Femoral Heads for the Treatment of Displaced Intracapsular Femoral Neck Fractures in the Elderly
Study Type
Interventional
2. Study Status
Record Verification Date
April 2010
Overall Recruitment Status
Unknown status
Study Start Date
April 2010 (undefined)
Primary Completion Date
June 2013 (Anticipated)
Study Completion Date
December 2013 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Wolfson Medical Center
4. Oversight
5. Study Description
Brief Summary
The purpose of this study is to compare hemiarthroplasty (HAP) with total hip arthroplasty (THA), performed by trained arthroplasty surgeons with the use of large femoral heads for the treatment of displaced femoral neck fractures in mobile independent elderly patients, to determine the impact of these surgical options on the short term functional outcomes and complication rates, namely dislocation and the need for further surgery.
This is a single-blinded prospective randomized clinical trial comparing functional outcome and complication rates of 40 patients treated with all cemented THA to a control group of 40 patients treated with cemented bipolar HAP, in a 2 years followup.
The primary endpoint is the Oxford hip score (OHS) at last followup as a measure of functional outcome. Secondary endpoints include the SF-36 score, walking distance and rates of postoperative dislocation, component loosening, need for revision and postoperative mortality.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Femoral Neck Fractures
Keywords
Femoral neck fractures, Hip fractures, Elderly, Total hip arthroplasty, Bipolar hemiarthroplasty
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
THA
Arm Type
Experimental
Arm Description
Total hip arthroplasty
Arm Title
HAP
Arm Type
Active Comparator
Arm Description
Bipolar Hemiarthroplasty
Intervention Type
Procedure
Intervention Name(s)
Total hip arthroplasty
Intervention Description
All cemented THA
Intervention Type
Procedure
Intervention Name(s)
Hemiarthroplasty
Intervention Description
Cemented bipolar HAP
Primary Outcome Measure Information:
Title
Oxford hip score (OHS)
Time Frame
last followup - 2 years
Secondary Outcome Measure Information:
Title
SF-36 score, walking distance
Time Frame
2 years followup
Title
dislocation rate, mortality rate
Time Frame
within follow up - 2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
70 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
1. Acute femoral neck fracture.
2. Age between 70 and 90 years old.
3. Independent community ambulator (more than 0.5km, without the aid of another person. The use of a cane is permitted) prior to fracture.
4. Abbreviated mental test score > 6 .
Exclusion Criteria:
1. Pathological fracture (excluding osteoporosis).
2. Rheumatoid arthritis.
3. Symptomatic arthrosis of the involved hip.
4. Neurological disorder that may significantly influence walking ability and/or tendency to dislocate.
5. Chronic corticosteroid use.
6. Concomitant other fracture.
7. Very high surgical risk.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dror Lakstein, MD
Phone
++972-3-5028383
Email
drorale@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dror Lakstein, MD
Organizational Affiliation
E. Wolfson medical center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Orthopaedic dept., E. Wolfson Medical center
City
Holon
ZIP/Postal Code
58100
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dror Lakstein, MD
Phone
++972-3-5028383
Email
drorale@gmail.com
12. IPD Sharing Statement
Learn more about this trial
Prospective Randomized Comparison of Bipolar Hemiarthroplasty and Total Hip Arthroplasty With Large Femoral Heads for the Treatment of Displaced Intracapsular Femoral Neck Fractures in the Elderly
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