Hemiarthroplasty or Internal Fixation for Displaced Femoral Neck Fractures

NCT00464230 | Completed Phase 4

• 1 other identifier: 12-2005-OS
• Study Type: interventional
• Target: 220
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Femoral Neck Fractures

Keywords

Displaced Femoral Neck Fractures; Treatment; Function; Pain; Quality of life; Complications; Reoperations; Internal Fixation; Hemiarthroplasty; Activities of Daily Living

Outcome Measures

Primary Outcomes (3)

• Harris Hip Score at 4, 12 and 24 months

• Barthel ADL Index at 4, 12 and 24 months

• Eq-5d (Euroqol) at 4, 12 and 24 months

Secondary Outcomes (4)

• Mortality

• Re-operations

• Complications

• Morbidity

Interventions

Bipolar hemiarthroplasty (Charnley/Hastings) PROCEDURE

Internal fixation with two parallel screws (Olmed) PROCEDURE

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Displaced femoral neck fracture
• Age 60 or above
• Able to walk (any aids allowed)

You may not qualify if:

• 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

Sponsors & Collaborators

• Ullevaal University Hospital: lead

Study Sites (1)

Orthopedic Center, Ulleval University Hospital

Oslo, 0408, Norway

Location

Related Publications (2)

• Waaler Bjornelv GM, Frihagen F, Madsen JE, Nordsletten L, Aas E. Hemiarthroplasty compared to internal fixation with percutaneous cannulated screws as treatment of displaced femoral neck fractures in the elderly: cost-utility analysis performed alongside a randomized, controlled trial. Osteoporos Int. 2012 Jun;23(6):1711-9. doi: 10.1007/s00198-011-1772-1. Epub 2011 Oct 14.

  PMID: 21997224 DERIVED

• 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. doi: 10.1136/bmj.39399.456551.25. Epub 2007 Dec 4.

  PMID: 18056740 DERIVED

MeSH Terms

Conditions

Femoral Neck Fractures; Pain

Interventions

Fracture Fixation, Internal

Condition Hierarchy (Ancestors)

Hip Fractures; Femoral Fractures; Fractures, Bone; Wounds and Injuries; Hip Injuries; Leg Injuries; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Fracture Fixation; Orthopedic Procedures; Therapeutics; Surgical Procedures, Operative

Study Officials

• Jan Erik Madsen, MD, PhD

  Orthopedic Center, Ulleval University Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: April 20, 2007
• First Posted: April 23, 2007
• Study Start: September 1, 2002
• Study Completion: March 1, 2006
• Last Updated: July 1, 2011

Record last verified: 2007-04

Locations

NO (1)