Prospective Randomized Comparison of Bipolar Hemiarthroplasty and Total Hip Arthroplasty With Large Femoral Heads for the Treatment of Displaced Intracapsular Femoral Neck Fractures in the Elderly

This study is currently recruiting participants.
Verified April 2010 by Wolfson Medical Center
Sponsor:
Information provided by:
Wolfson Medical Center
ClinicalTrials.gov Identifier:
NCT01109862
First received: April 22, 2010
Last updated: June 16, 2011
Last verified: April 2010

April 22, 2010
June 16, 2011
April 2010
June 2013   (final data collection date for primary outcome measure)
Oxford hip score (OHS) [ Time Frame: last followup - 2 years ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01109862 on ClinicalTrials.gov Archive Site
  • SF-36 score, walking distance [ Time Frame: 2 years followup ] [ Designated as safety issue: No ]
  • dislocation rate, mortality rate [ Time Frame: within follow up - 2 years ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Prospective Randomized Comparison of Bipolar Hemiarthroplasty and Total Hip Arthroplasty With Large Femoral Heads for the Treatment of Displaced Intracapsular Femoral Neck Fractures in the Elderly
Prospective Randomized Comparison of Bipolar Hemiarthroplasty and Total Hip Arthroplasty With Large Femoral Heads for the Treatment of Displaced Intracapsular Femoral Neck Fractures in the Elderly

The purpose of this study is to compare hemiarthroplasty (HAP) with total hip arthroplasty (THA), performed by trained arthroplasty surgeons with the use of large femoral heads for the treatment of displaced femoral neck fractures in mobile independent elderly patients, to determine the impact of these surgical options on the short term functional outcomes and complication rates, namely dislocation and the need for further surgery.

This is a single-blinded prospective randomized clinical trial comparing functional outcome and complication rates of 40 patients treated with all cemented THA to a control group of 40 patients treated with cemented bipolar HAP, in a 2 years followup.

The primary endpoint is the Oxford hip score (OHS) at last followup as a measure of functional outcome. Secondary endpoints include the SF-36 score, walking distance and rates of postoperative dislocation, component loosening, need for revision and postoperative mortality.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Femoral Neck Fractures
  • Procedure: Total hip arthroplasty
    All cemented THA
  • Procedure: Hemiarthroplasty
    Cemented bipolar HAP
  • Experimental: THA
    Total hip arthroplasty
    Intervention: Procedure: Total hip arthroplasty
  • Active Comparator: HAP
    Bipolar Hemiarthroplasty
    Intervention: Procedure: Hemiarthroplasty
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
80
December 2013
June 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • 1. Acute femoral neck fracture.
  • 2. Age between 70 and 90 years old.
  • 3. Independent community ambulator (more than 0.5km, without the aid of another person. The use of a cane is permitted) prior to fracture.
  • 4. Abbreviated mental test score > 6 .

Exclusion Criteria:

  • 1. Pathological fracture (excluding osteoporosis).
  • 2. Rheumatoid arthritis.
  • 3. Symptomatic arthrosis of the involved hip.
  • 4. Neurological disorder that may significantly influence walking ability and/or tendency to dislocate.
  • 5. Chronic corticosteroid use.
  • 6. Concomitant other fracture.
  • 7. Very high surgical risk.
Both
70 Years to 90 Years
No
Contact: Dror Lakstein, MD ++972-3-5028383 drorale@gmail.com
Israel
 
NCT01109862
0019-10-WOMC
Not Provided
Dror Lakstein, MD, Orthopaedic dept, E.Wolfson medical center
Wolfson Medical Center
Not Provided
Principal Investigator: Dror Lakstein, MD E. Wolfson medical center
Wolfson Medical Center
April 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP