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Clinical Trials/NCT02247791
NCT02247791
Active, Not Recruiting
N/A

Study of Prosthesis Choice in Older Patients With a Dislocated Femoral Neck Fracture of the Hip

Danderyd Hospital1 site in 1 country140 target enrollmentSeptember 2009
ConditionsHip Fractures

Overview

Phase
N/A
Intervention
Not specified
Conditions
Hip Fractures
Sponsor
Danderyd Hospital
Enrollment
140
Locations
1
Primary Endpoint
Hip related complication rate
Status
Active, Not Recruiting
Last Updated
10 years ago

Overview

Brief Summary

The purpose of this study is to evaluate whether an uncemented hip prosthesis is as safe as an cemented hip prosthesis for patients undergoing total hip arthroplasty surgery following a displaced femoral neck fracture.

Detailed Description

The study will randomize patients between an uncemented and cemented stem

Registry
clinicaltrials.gov
Start Date
September 2009
End Date
September 2024
Last Updated
10 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Danderyd Hospital
Responsible Party
Principal Investigator
Principal Investigator

Olof Skoldenberg

Director of research, Orthopaedic dept

Danderyd Hospital

Eligibility Criteria

Inclusion Criteria

  • Acute Displaced femoral neck fracture
  • Subject is aged between 65-79 years
  • Independent walker with or without walking aides
  • Subject is able and capable of providing consent to participate in the study

Exclusion Criteria

  • Patients with Rheumatoid Arthritis
  • Patients with an impaired cognitive dysfunction
  • Patients with Pathological fractures
  • Patients with substance abuse
  • Patients with fracture older than 36-hours on arrival at the A\&E
  • Patients suffering from cancer
  • Patients determined by principal investigator to be unsuitable for inclusion

Outcomes

Primary Outcomes

Hip related complication rate

Time Frame: 2 years

All hip-related complications

Health-related Quality of Life

Time Frame: 2 years

Health related quality of life

Secondary Outcomes

  • Intraoperative bleeding(2 years)
  • Duration of surgery(2 years)
  • Hip function(2 years)

Study Sites (1)

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