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Hemiarthroplasty or Internal Fixation for Displaced Femoral Neck Fractures

Primary Purpose

Femoral Neck Fractures

Status
Completed
Phase
Phase 4
Locations
Norway
Study Type
Interventional
Intervention
Bipolar hemiarthroplasty (Charnley/Hastings)
Internal fixation with two parallel screws (Olmed)
Sponsored by
Ullevaal University Hospital
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Femoral Neck Fractures focused on measuring Displaced Femoral Neck Fractures, Treatment, Function, Pain, Quality of life, Complications, Reoperations, Internal Fixation, Hemiarthroplasty, Activities of Daily Living

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Orthopedic Center, Ulleval University Hospital

Outcomes

Primary Outcome Measures

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 Outcome Measures

Mortality
Re-operations
Complications
Morbidity

Full Information

First Posted
April 20, 2007
Last Updated
June 30, 2011
Sponsor
Ullevaal University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT00464230
Brief Title
Hemiarthroplasty or Internal Fixation for Displaced Femoral Neck Fractures
Official Title
The Management of Intracapsular Fractures of the Proximal Femur. A Prospective, Randomized Trial of Two Parallel Screws and Hemiarthroplasty
Study Type
Interventional

2. Study Status

Record Verification Date
April 2007
Overall Recruitment Status
Completed
Study Start Date
September 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
March 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Ullevaal University Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
Detailed 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: 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Femoral Neck Fractures
Keywords
Displaced Femoral Neck Fractures, Treatment, Function, Pain, Quality of life, Complications, Reoperations, Internal Fixation, Hemiarthroplasty, Activities of Daily Living

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Single
Allocation
Randomized
Enrollment
220 (false)

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
Bipolar hemiarthroplasty (Charnley/Hastings)
Intervention Type
Procedure
Intervention Name(s)
Internal fixation with two parallel screws (Olmed)
Primary Outcome Measure Information:
Title
Harris Hip Score at 4, 12 and 24 months
Title
Barthel ADL Index at 4, 12 and 24 months
Title
Eq-5d (Euroqol) at 4, 12 and 24 months
Secondary Outcome Measure Information:
Title
Mortality
Title
Re-operations
Title
Complications
Title
Morbidity

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jan Erik Madsen, MD, PhD
Organizational Affiliation
Orthopedic Center, Ulleval University Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Orthopedic Center, Ulleval University Hospital
City
Oslo
ZIP/Postal Code
0408
Country
Norway

12. IPD Sharing Statement

Citations:
PubMed Identifier
21997224
Citation
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.
Results Reference
derived
PubMed Identifier
18056740
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. doi: 10.1136/bmj.39399.456551.25. Epub 2007 Dec 4.
Results Reference
derived

Learn more about this trial

Hemiarthroplasty or Internal Fixation for Displaced Femoral Neck Fractures

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