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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2011 by Oslo University Hospital.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborators:
Norwegian Foundation for Health and Rehabilitation
The Research Council of Norway
Information provided by:
Oslo University Hospital
ClinicalTrials.gov Identifier:
NCT00764153
First received: September 29, 2008
Last updated: July 22, 2011
Last verified: July 2011
  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:


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:

  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.

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
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:National Committee for Medical and Health Research Ethics
Norway: Data Protection Authority

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 August 28, 2014