Back to resultsTotal Hip Arthroplasty Compared to Internal Fixation for Displaced Intracapsular Fractures of the Femoral Neck
Primary Purpose
Femoral Neck Fracture
Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Internal fixation
Total hip arthroplasty
Sponsored by
About this trial
This is an interventional treatment trial for Femoral Neck Fracture focused on measuring femoral neck fracture, total hip arthroplasty, internal fixation
Eligibility Criteria
Inclusion Criteria:
- Acute displaced femoral neck fracture Garden III or IV,
- Age over 65 years,
- Admission from their own home,
- No concurrent joint disease or previous fracture in the lower extremities,
- Healthy or controlled medical conditions without significant systemic effects (ASA 1-2),
- Harris hip score of 100
- Acceptance from the patient to participate in the study.
Sites / Locations
- Danderyd Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Internal fixation
Total hip replacement
Arm Description
Displaced femoral neck fracture treated with internal fixation using two parallel cannulated screws.
Displaced femoral neck fracture treated with total hip replacement through a posterior approach.
Outcomes
Primary Outcome Measures
Harris hip score
HHS index score of 0 indicates the worst possible function of the hip and a value of 100 indicates full function.
Secondary Outcome Measures
Reoperations and complications
IF group: nonunion, osteonecrosis, deep infection or fracture in the vicinity of the screws. Protruding screws or extraction of the screws when the fracture was healed was not defined as a complication.
THR group: radiographic signs of loosening of the femoral- or acetabular component, dislocation, periprosthetic fracture or deep infection
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01344772
Brief Title
Total Hip Arthroplasty Compared to Internal Fixation for Displaced Intracapsular Fractures of the Femoral Neck
Official Title
Total Hip Arthroplasty Compared to Internal Fixation for Displaced Intracapsular Fractures of the Femoral Neck. A Randomized, Controlled Trial With a Seventeen Year Follow-up
Study Type
Interventional
2. Study Status
Record Verification Date
November 2012
Overall Recruitment Status
Completed
Study Start Date
February 1990 (undefined)
Primary Completion Date
June 2010 (Actual)
Study Completion Date
June 2011 (Actual)
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
The primary aim of this study was to determine the Harris hip score as an evaluation of hip function, in mentally competent elderly patients (>65 years old) treated with either THR or IF, after contracting a displaced femoral neck fracture. The secondary aim was to compare the rate of reoperations and complications between the two groups.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Femoral Neck Fracture
Keywords
femoral neck fracture, total hip arthroplasty, internal fixation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Internal fixation
Arm Type
Active Comparator
Arm Description
Displaced femoral neck fracture treated with internal fixation using two parallel cannulated screws.
Arm Title
Total hip replacement
Arm Type
Active Comparator
Arm Description
Displaced femoral neck fracture treated with total hip replacement through a posterior approach.
Intervention Type
Procedure
Intervention Name(s)
Internal fixation
Intervention Description
Two cannulated screws are placed under x-ray guidance
Intervention Type
Procedure
Intervention Name(s)
Total hip arthroplasty
Intervention Description
A total hip arthroplasty is performed through a standard posterior approach
Primary Outcome Measure Information:
Title
Harris hip score
Description
HHS index score of 0 indicates the worst possible function of the hip and a value of 100 indicates full function.
Time Frame
17 years
Secondary Outcome Measure Information:
Title
Reoperations and complications
Description
IF group: nonunion, osteonecrosis, deep infection or fracture in the vicinity of the screws. Protruding screws or extraction of the screws when the fracture was healed was not defined as a complication.
THR group: radiographic signs of loosening of the femoral- or acetabular component, dislocation, periprosthetic fracture or deep infection
Time Frame
17 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Acute displaced femoral neck fracture Garden III or IV,
Age over 65 years,
Admission from their own home,
No concurrent joint disease or previous fracture in the lower extremities,
Healthy or controlled medical conditions without significant systemic effects (ASA 1-2),
Harris hip score of 100
Acceptance from the patient to participate in the study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Olof Sköldenberg, MD, PhD
Organizational Affiliation
Danderyd Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Danderyd Hospital
City
Stockholm
ZIP/Postal Code
182 88
Country
Sweden
12. IPD Sharing Statement
Learn more about this trial
Total Hip Arthroplasty Compared to Internal Fixation for Displaced Intracapsular Fractures of the Femoral Neck
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