Total Hip Arthroplasty Compared to Internal Fixation for Displaced Intracapsular Fractures of the Femoral Neck
1 other identifier
interventional
100
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Feb 1990
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 1990
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2010
CompletedFirst Submitted
Initial submission to the registry
April 28, 2011
CompletedFirst Posted
Study publicly available on registry
April 29, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2011
CompletedNovember 27, 2012
November 1, 2012
20.3 years
April 28, 2011
November 23, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Harris hip score
HHS index score of 0 indicates the worst possible function of the hip and a value of 100 indicates full function.
17 years
Secondary Outcomes (1)
Reoperations and complications
17 years
Study Arms (2)
Internal fixation
ACTIVE COMPARATORDisplaced femoral neck fracture treated with internal fixation using two parallel cannulated screws.
Total hip replacement
ACTIVE COMPARATORDisplaced femoral neck fracture treated with total hip replacement through a posterior approach.
Interventions
A total hip arthroplasty is performed through a standard posterior approach
Eligibility Criteria
You may qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Danderyd Hospital
Stockholm, 182 88, Sweden
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Olof Sköldenberg, MD, PhD
Danderyd Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Consulatant Orthopaedic Surgeon, PhD
Study Record Dates
First Submitted
April 28, 2011
First Posted
April 29, 2011
Study Start
February 1, 1990
Primary Completion
June 1, 2010
Study Completion
June 1, 2011
Last Updated
November 27, 2012
Record last verified: 2012-11