Hemiarthroplasty or Internal Fixation for Displaced Femoral Neck Fractures

Femoral Neck Fractures Clinical Trial

Official title:

The Management of Intracapsular Fractures of the Proximal Femur. A Prospective, Randomized Trial of Two Parallel Screws and Hemiarthroplasty

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00464230
• Other study ID #: 12-2005-OS
• Status: Completed
• Phase: Phase 4
• First received: April 20, 2007
• Last updated: June 30, 2011
• Start date: September 2002
• Est. completion date: March 2006

Study information

• Verified date: April 2007
• Source: Oslo University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway:National Committee for Medical and Health Research Ethics
• Study type: Interventional

Clinical Trial Summary

An estimated 1.6 million patients sustain a hip fracture every year, about half of these are intracapsular femoral neck fractures. A femoral neck fracture is a life changing event for any patient, and the risk of disability, increased dependence and death is substantial. The main treatment options for displaced femoral neck fractures are internal fixation and arthroplasty. It is established that there are more complications and reoperations after internal fixation, but there is no consensus about which procedure that gives best functional results.

Description:

We plan to include patients with displaced intracapsular femoral neck fractures. The patients will be randomized by means of closed numbered envelopes to operation groups:

1. Two parallel screws (Olmed).

2. Hemiarthroplasty with Charnley/ Hastings prosthesis. A priori one would expect that there would be less morbidity and mortality with the less extensive and quicker operation with parallel screw and that a faster and better rehabilitation would be achieved with hemiarthroplasty.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 220
• Est. completion date: March 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 60 Years and older

Eligibility

Inclusion Criteria:

• Displaced femoral neck fracture

• Age 60 or above

• Able to walk (any aids allowed)

Exclusion Criteria:

• Anesthesiologically unfit for arthroplasty surgery

• Previous symptomatic hip pathology (i.e. arthritis)

• Pathological fracture

• Delay of more than 96 hours from injury to treatment

• Not living in hospital area

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Femoral Neck Fractures
• Fractures, Bone

Intervention

Procedure:
• Bipolar hemiarthroplasty (Charnley/Hastings)

• Internal fixation with two parallel screws (Olmed)

Locations

Country	Name	City	State
Norway	Orthopedic Center, Ulleval University Hospital	Oslo

Sponsors (1)

Lead Sponsor	Collaborator
Ullevaal University Hospital

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Harris Hip Score at 4, 12 and 24 months
Primary	Barthel ADL Index at 4, 12 and 24 months
Primary	Eq-5d (Euroqol) at 4, 12 and 24 months
Secondary	Mortality
Secondary	Re-operations
Secondary	Complications
Secondary	Morbidity