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

NCT01109862 | Unknown Phase 1

• 1 other identifier: 0019-10-WOMC
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Femoral Neck Fractures

Keywords

Femoral neck fractures; Hip fractures; Elderly; Total hip arthroplasty; Bipolar hemiarthroplasty

Outcome Measures

Primary Outcomes (1)

• Oxford hip score (OHS)

  last followup - 2 years

Secondary Outcomes (2)

• SF-36 score, walking distance

  2 years followup

• dislocation rate, mortality rate

  within follow up - 2 years

Study Arms (2)

THA

EXPERIMENTAL

Total hip arthroplasty

Procedure: Total hip arthroplasty

HAP

ACTIVE COMPARATOR

Bipolar Hemiarthroplasty

Procedure: Hemiarthroplasty

Interventions

Total hip arthroplasty PROCEDURE

All cemented THA

THA

Hemiarthroplasty PROCEDURE

Cemented bipolar HAP

HAP

Eligibility Criteria

• Age: 70 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• \. Pathological fracture (excluding osteoporosis).
• \. Rheumatoid arthritis.
• \. Symptomatic arthrosis of the involved hip.
• \. Neurological disorder that may significantly influence walking ability and/or tendency to dislocate.
• \. Chronic corticosteroid use.
• \. Concomitant other fracture.
• \. Very high surgical risk.

Sponsors & Collaborators

• Wolfson Medical Center: lead

Study Sites (1)

Orthopaedic dept., E. Wolfson Medical center

Holon, 58100, Israel

RECRUITING

Related Links

• Institutional web site

MeSH Terms

Conditions

Femoral Neck Fractures; Hip Fractures

Interventions

Arthroplasty, Replacement, Hip; Hemiarthroplasty

Condition Hierarchy (Ancestors)

Femoral Fractures; Fractures, Bone; Wounds and Injuries; Hip Injuries; Leg Injuries

Intervention Hierarchy (Ancestors)

Arthroplasty, Replacement; Arthroplasty; Orthopedic Procedures; Surgical Procedures, Operative; Plastic Surgery Procedures; Prosthesis Implantation

Study Officials

• Dror Lakstein, MD

  E. Wolfson medical center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dror Lakstein, MD

CONTACT

++972-3-5028383; drorale@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV

Study Record Dates

• First Submitted: April 22, 2010
• First Posted: April 23, 2010
• Study Start: April 1, 2010
• Primary Completion: June 1, 2013
• Study Completion: December 1, 2013
• Last Updated: June 17, 2011

Record last verified: 2010-04

Locations

IL (1)