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

Status

UNKNOWN

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01109862

Enrollment

Registered

2010-04-23

Start date

2010-04-30

Completion date

2013-12-31

Last updated

2011-06-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Femoral Neck Fractures

Keywords

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

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.

Interventions

PROCEDURETotal hip arthroplasty

All cemented THA

PROCEDUREHemiarthroplasty

Cemented bipolar HAP

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

70 Years to 90 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
Oxford hip score (OHS)	last followup - 2 years

Secondary

Measure	Time frame
SF-36 score, walking distance	2 years followup
dislocation rate, mortality rate	within follow up - 2 years

Countries

Israel

Contacts

Primary ContactDror Lakstein, MD

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026