- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02590731
The Influence of Cognitive Status on Walking Abilities After Femoral Neck Fracture
The Influence of Cognitive Status on Walking Abilities After Hemiarthroplasty for Femoral Neck Fracture: a Prospective Cohort Study
Introduction: Femoral neck fracture is a devastating injury with serious medical and social consequences. One third of these patients have some degree of impaired cognitive status. Despite of this, a high proportion of hip fracture trials exclude patients with cognitive impairment. The investigators aimed to evaluate whether moderate to severe cognitive impairment could predict walking ability, quality of life, functional outcome, reoperations and mortality in elderly patients treated with hemiarthroplasty.
Methods: This cohort study included a consecutive series of 188 patients treated with hemiarthroplasty for an displaced femoral neck fracture. Patient were assessed for estimated preoperative and 1 year postoperatively with regard to walking abilities, cognitive status, quality of life with EQ-5D and hip function with Harris hip score.
Study Overview
Status
Conditions
Study Type
Enrollment (Actual)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- 65 year or above
- Displaced femoral neck fracture
- Treated with a hemiarthroplasty
Exclusion Criteria:
- Pathological fractures
- Bilateral femoral neck fractures
- Bed-ridden patients.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
---|
Control group
Pfeiffer test 6 or above.
No or mild cognitive impairment
|
Cognitivt impaired
Pfeiffer test less than 6.
Moderate to severe cognitive impairment.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Walking abilities
Time Frame: 2 years
|
At follow-up patients report whether they are walking or not by questionnaire
|
2 years
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Mortality
Time Frame: 2 years
|
2 years
|
Harris hip score
Time Frame: 2 years
|
2 years
|
EQ-5D
Time Frame: 2 years
|
2 years
|
Reoperation
Time Frame: 2 years
|
2 years
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SM_III
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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