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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

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ClinicalTrials.gov Identifier: NCT01109862
Recruitment Status : Unknown
Verified April 2010 by Wolfson Medical Center.
Recruitment status was:  Recruiting
First Posted : April 23, 2010
Last Update Posted : June 17, 2011
Sponsor:
Information provided by:
Wolfson Medical Center

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Femoral Neck Fractures Procedure: Total hip arthroplasty Procedure: Hemiarthroplasty Phase 1

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : April 2010
Estimated Primary Completion Date : June 2013
Estimated Study Completion Date : December 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: THA
Total hip arthroplasty
Procedure: Total hip arthroplasty
All cemented THA
Active Comparator: HAP
Bipolar Hemiarthroplasty
Procedure: Hemiarthroplasty
Cemented bipolar HAP



Primary Outcome Measures :
  1. Oxford hip score (OHS) [ Time Frame: last followup - 2 years ]

Secondary Outcome Measures :
  1. SF-36 score, walking distance [ Time Frame: 2 years followup ]
  2. dislocation rate, mortality rate [ Time Frame: within follow up - 2 years ]


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Ages Eligible for Study:   70 Years to 90 Years   (Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01109862


Contacts
Contact: Dror Lakstein, MD ++972-3-5028383 drorale@gmail.com

Locations
Israel
Orthopaedic dept., E. Wolfson Medical center Recruiting
Holon, Israel, 58100
Contact: Dror Lakstein, MD    ++972-3-5028383    drorale@gmail.com   
Sponsors and Collaborators
Wolfson Medical Center
Investigators
Principal Investigator: Dror Lakstein, MD E. Wolfson medical center

Additional Information:
Responsible Party: Dror Lakstein, MD, Orthopaedic dept, E.Wolfson medical center
ClinicalTrials.gov Identifier: NCT01109862     History of Changes
Other Study ID Numbers: 0019-10-WOMC
First Posted: April 23, 2010    Key Record Dates
Last Update Posted: June 17, 2011
Last Verified: April 2010

Keywords provided by Wolfson Medical Center:
Femoral neck fractures
Hip fractures
Elderly
Total hip arthroplasty
Bipolar hemiarthroplasty

Additional relevant MeSH terms:
Fractures, Bone
Femoral Neck Fractures
Wounds and Injuries
Hip Fractures
Femoral Fractures
Hip Injuries
Leg Injuries