The Influence of Cognitive Status on Walking Abilities After Femoral Neck Fracture

Hip Fracture Clinical Trial

Official title:

The Influence of Cognitive Status on Walking Abilities After Hemiarthroplasty for Femoral Neck Fracture: a Prospective Cohort Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02590731
• Other study ID #: SM_III
• Status: Completed
• Phase: N/A
• First received: October 13, 2015
• Last updated: February 28, 2016
• Start date: February 2012
• Est. completion date: October 2015

Study information

• Verified date: February 2016
• Source: Sundsvall Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Regional Ethical Review Board
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 188
• Est. completion date: October 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 65 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Femoral Neck Fracture
• Femoral Neck Fractures
• Fractures, Bone
• Hip Fracture
• Hip Fractures

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Sundsvall Hospital

References & Publications (1)

Hedbeck CJ, Inngul C, Blomfeldt R, Ponzer S, Törnkvist 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Walking abilities	At follow-up patients report whether they are walking or not by questionnaire	2 years	No
Secondary	Harris hip score		2 years	No
Secondary	EQ-5D		2 years	No
Secondary	Reoperation		2 years	No
Secondary	Mortality		2 years	No