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

Sponsor:	Ullevaal University Hospital
Collaborators:	Norwegian Foundation for Health and Rehabilitation The Research Council of Norway
Information provided by:	Oslo University Hospital
ClinicalTrials.gov Identifier:	NCT00764153

Purpose

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.

Condition	Intervention
Femoral Neck Fractures	Procedure: Bipolar hemiarthroplasty Procedure: Internal fixation

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment
Official Title:	Hemiarthroplasty or Internal Fixation for Displaced Femoral Neck Fractures - 5 Years Follow up

Resource links provided by NLM:

MedlinePlus related topics: Fractures

U.S. FDA Resources

Further study details as provided by Oslo University Hospital:

Primary Outcome Measures:

Harris Hip Score [ Time Frame: 5-6 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Eq-5d [ Time Frame: 5-6 years ] [ Designated as safety issue: No ]
Barthel Index [ Time Frame: 5-6 years ] [ Designated as safety issue: No ]
Reoperations and complications [ Time Frame: 5-6 years ] [ Designated as safety issue: No ]

Enrollment:	222
Study Start Date:	October 2002
Estimated Study Completion Date:	December 2011
Estimated Primary Completion Date:	November 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Internal fixation Closed reduction and internal fixation with two parallel screws (Olmed)	Procedure: Internal fixation Fluoroscopic Control. Percutaneous. FWB. Two parallel screws (Olmed) Other Name: Olmed (DePuy)
Bipolar hemiarthroplasty Hemiarthroplasty with Charnley/ Hastings prosthesis	Procedure: Bipolar hemiarthroplasty Lateral approach. FWB. Other Name: Charnley/Hastings

Detailed 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:

Two parallel screws (Olmed).
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.

Eligibility

Ages Eligible for Study:	60 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00764153

Sponsors and Collaborators

Ullevaal University Hospital

Norwegian Foundation for Health and Rehabilitation

The Research Council of Norway

Investigators

Study Chair:

Jan Erik Madsen, MD PhD

Orthopedic Center, Ulleval University Hospital, Oslo, Norway

More Information

Publications:

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.

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. Epub 2008 Jul 25.

Responsible Party:	Frede Frihagen, Ulleval University Hospital
ClinicalTrials.gov Identifier:	NCT00764153 History of Changes
Other Study ID Numbers:	12-2005-OS-2
Study First Received:	September 29, 2008
Last Updated:	July 22, 2011
Health Authority:	Norway: The National Committees for Research Ethics in Norway; Norway: Data Inspectorate

Keywords provided by Oslo University Hospital:

Displaced Femoral Neck Fractures
Treatment
Function
Pain
Quality of life

Complications
Reoperations
Internal Fixation
Hemiarthroplasty
Activities of Daily Living

Additional relevant MeSH terms:

Femoral Neck Fractures
Fractures, Bone
Hip Fractures

Femoral Fractures
Wounds and Injuries
Leg Injuries

ClinicalTrials.gov processed this record on February 09, 2012