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 recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2010 by Wolfson Medical Center.
Recruitment status was  Recruiting
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
  Purpose

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 Intervention Phase
Femoral Neck Fractures
Procedure: Total hip arthroplasty
Procedure: Hemiarthroplasty
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (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

Resource links provided by NLM:


Further study details as provided by Wolfson Medical Center:

Primary Outcome Measures:
  • Oxford hip score (OHS) [ Time Frame: last followup - 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 80
Study Start Date: April 2010
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: THA
Total hip arthroplasty
Procedure: Total hip arthroplasty
All cemented THA
Active Comparator: HAP
Bipolar Hemiarthroplasty
Procedure: Hemiarthroplasty
Cemented bipolar HAP

  Eligibility

Ages Eligible for Study:   70 Years to 90 Years
Genders Eligible for Study:   Both
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.
  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: 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
  More Information

Additional Information:
No publications provided

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
Study First Received: April 22, 2010
Last Updated: June 16, 2011
Health Authority: Israel: Ministry of Health

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

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