Hemiarthroplasty or Internal Fixation for Displaced Femoral Neck Fractures - 5 Years Follow up

Femoral Neck Fractures Clinical Trial

Official title:

Hemiarthroplasty or Internal Fixation for Displaced Femoral Neck Fractures - 5 Years Follow up

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00764153
• Other study ID #: 12-2005-OS-2
• Status: Completed
• Phase: N/A
• First received: September 29, 2008
• Last updated: October 22, 2014
• Start date: October 2002
• Est. completion date: December 2011

Study information

• Verified date: October 2014
• Source: Oslo University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway:National Committee for Medical and Health Research EthicsNorway: Data Protection Authority
• 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, and better short term clinical results with arthroplasty, but knowledge about long term results is lacking.

Description:

Patients were included from 2002-2004. Two years follow up was finished by 2006. Patients with displaced intracapsular femoral neck fractures were included and 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: 222
• Est. completion date: December 2011
• Est. primary completion date: November 2011
• 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 (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Femoral Neck Fractures
• Fractures, Bone

Intervention

Procedure:
• Bipolar hemiarthroplasty
Lateral approach. FWB.
• Internal fixation
Fluoroscopic Control. Percutaneous. FWB. Two parallel screws (Olmed)

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Ullevaal University Hospital	Norwegian Foundation for Health and Rehabilitation, The Research Council of Norway

References & Publications (3)

Frihagen F, Grotle M, Madsen JE, Wyller TB, Mowinckel P, Nordsletten L. Outcome after femoral neck fractures: a comparison of Harris Hip Score, Eq-5d and Barthel Index. Injury. 2008 Oct;39(10):1147-56. doi: 10.1016/j.injury.2008.03.027. Epub 2008 Jul 25. — View Citation

Frihagen F, Nordsletten L, Madsen JE. Hemiarthroplasty or internal fixation for intracapsular displaced femoral neck fractures: randomised controlled trial. BMJ. 2007 Dec 15;335(7632):1251-4. Epub 2007 Dec 4. — View Citation

Støen RØ, Lofthus CM, Nordsletten L, Madsen JE, Frihagen F. Randomized trial of hemiarthroplasty versus internal fixation for femoral neck fractures: no differences at 6 years. Clin Orthop Relat Res. 2014 Jan;472(1):360-7. doi: 10.1007/s11999-013-3245-7. Epub 2013 Aug 24. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Harris Hip Score		5-6 years	No
Secondary	Eq-5d		5-6 years	No
Secondary	Barthel Index		5-6 years	No
Secondary	Reoperations and complications		5-6 years	No