NCT02590731

Brief 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. 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
188

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2012

Typical duration for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2012

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2015

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

October 13, 2015

Completed
16 days until next milestone

First Posted

Study publicly available on registry

October 29, 2015

Completed
Last Updated

March 1, 2016

Status Verified

February 1, 2016

Enrollment Period

3.6 years

First QC Date

October 13, 2015

Last Update Submit

February 28, 2016

Conditions

Outcome Measures

Primary Outcomes (1)

  • Walking abilities

    At follow-up patients report whether they are walking or not by questionnaire

    2 years

Secondary Outcomes (4)

  • Harris hip score

    2 years

  • EQ-5D

    2 years

  • Reoperation

    2 years

  • Mortality

    2 years

Study Arms (2)

Control group

Pfeiffer test 6 or above. No or mild cognitive impairment

Cognitivt impaired

Pfeiffer test less than 6. Moderate to severe cognitive impairment.

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patient with displaced femoral neck fractures.

You may qualify if:

  • year or above
  • Displaced femoral neck fracture
  • Treated with a hemiarthroplasty

You may not qualify if:

  • Pathological fractures
  • Bilateral femoral neck fractures
  • Bed-ridden patients.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

    PMID: 23515127BACKGROUND

MeSH Terms

Conditions

Hip FracturesFemoral Neck Fractures

Condition Hierarchy (Ancestors)

Femoral FracturesFractures, BoneWounds and InjuriesHip InjuriesLeg Injuries

Study Officials

  • Sebastian Mukka, M.D, PhD

    Umeå University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 13, 2015

First Posted

October 29, 2015

Study Start

February 1, 2012

Primary Completion

September 1, 2015

Study Completion

October 1, 2015

Last Updated

March 1, 2016

Record last verified: 2016-02