Hip FractureNCT02590731
The Influence of Cognitive Status on Walking Abilities After Femoral Neck Fracture
An observational study of Hip Fracture and Femoral Neck Fracture, run by Sundsvall Hospital.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Hip Fracture, Femoral Neck Fracture
- How many people
- 188 participants
- Where
- No sites listed yet
- Study dates
- Feb 2012to Oct 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: Patient with displaced femoral neck fractures.
Who may be able to join
- 65 year or above
- Displaced femoral neck fracture
- Treated with a hemiarthroplasty
Who cannot join
- Pathological fractures
- Bilateral femoral neck fractures
- Bed-ridden patients.
About this study
Official title: 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.
- Conditions
- Hip Fracture, Femoral Neck Fracture
- Medical subject headings
- Hip Fractures, Femoral Neck Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Walking abilities
At follow-up patients report whether they are walking or not by questionnaire
Measured: 2 years
Secondary outcomes (4)
Harris hip score
Measured: 2 years
EQ-5D
Measured: 2 years
Reoperation
Measured: 2 years
Mortality
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2015 (estimated)
- Study startFeb 2012
- Primary completionSep 2015
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hip FractureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 188 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sundsvall Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sebastian Mukka, M.D, PhD, Principal investigator, Umeå University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02590731
- Sponsor's protocol ID
- SM_III
- Status last verified
- Feb 2016
- First submitted
- 13 Oct 2015
- Last updated
- 1 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Hedbeck CJ, Inngul C, Blomfeldt R, Ponzer S, Tornkvist H, Enocson A. Internal fixation versus cemented hemiarthroplasty for displaced femoral neck fractures in patients with severe cognitive dysfunction: a randomized controlled trial. J Orthop Trauma. 2013 Dec;27(12):690-5. doi: 10.1097/BOT.0b013e318291f544.
PubMed 23515127
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of Cognitive Status on Walking Abilities After Hemiarthroplasty for Femoral Neck Fracture: a Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT02590731
- Acronym / sponsor ID
- SM_III
- Conditions
- Hip Fracture, Femoral Neck Fracture
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 188 participants (actual)
- Lead sponsor
- Sundsvall HospitalUniversity, hospital or other
- Study start
- Feb 2012
- Primary completion
- Sep 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 29 Oct 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | – | –Pfeiffer test 6 or above. No or mild cognitive impairment |
| Cognitivt impaired | – | –Pfeiffer test less than 6. Moderate to severe cognitive impairment. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Patient with displaced femoral neck fractures.
Key inclusion criteria (3 listed)
- 65 year or above
- Displaced femoral neck fracture
- Treated with a hemiarthroplasty
Key exclusion criteria (3 listed)
- Pathological fractures
- Bilateral femoral neck fractures
- Bed-ridden patients.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Walking abilities
Time frame: 2 years
At follow-up patients report whether they are walking or not by questionnaire
4 secondary outcomes
Harris hip score
Time frame: 2 years
EQ-5D
Time frame: 2 years
Reoperation
Time frame: 2 years
Mortality
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2016.
- Background: PubMed 23515127Hedbeck CJ, Inngul C, Blomfeldt R, Ponzer S, Tornkvist H, Enocson A. Internal fixation versus cemented hemiarthroplasty for displaced femoral neck fractures in patients with severe cognitive dysfunction: a randomized controlled trial. J Orthop Trauma. 2013 Dec;27(12):690-5. doi: 10.1097/BOT.0b013e318291f544.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sebastian Mukka, M.D, PhD principal investigator
Umeå University
Questions about this trial
What is this clinical trial studying?
An observational study of Hip Fracture and Femoral Neck Fracture, run by Sundsvall Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Walking abilities (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02590731, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Mar 2016.