Unipolar or Bipolar Hemiarthroplasty in the Treatment of Displaced Femoral Neck Fractures.

Unipolar or Bipolar Hemiarthroplasty in the Treatment of Displaced Femoral Neck Fractures. A Randomized Trial of RSA Measurements of Acetabular Wear.

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00746876

Acronym

HEMIUNIBIPOL

Enrollment

Registered

2008-09-04

Start date

2009-09-30

Completion date

2015-12-31

Last updated

2016-04-19

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

Conditions

Hip Fractures

Keywords

Hip, Fracture, Femoral neck, Hemiarthroplasty, Bipolar, Unipolar, Displaced femoral neck fractures

Brief summary

Hemiarthroplasty of the hip is standard treatment of femoral neck fractures (hip fractures). Hemiarthroplasty means replacing the hip joint with a metal prosthesis. Unipolar prostheses has a one-piece design where the hip movement occurs between the prosthesis and the acetabulum (hip socket). A bipolar prosthesis has an additional artificial joint between the two components of the prosthesis. Both treatments are clinically proven and common around the world. No clinical trial has proven benefits of one or the other prosthesis design. The investigators want to measure the differences in acetabular wear using these two prostheses, using radiostereometric measurements.

Detailed description

Patients 70 years or older presenting to our hospital with an acute femoral neck fracture are eligible for inclusion. 15 patients in each group will be recruited. One group receives a unipolar hemiarthroplasty and 15 receives a bipolar arthroplasty. Tantalum markers are placed around the acetabulum during surgery. Follow-up intervals are at 3, 12 and 24 months with radiostereometric evaluation (radiographs) and clinical evaluation.

Interventions

DEVICEUnipolar hip hemiarthroplasty

Unipolar hip hemiarthroplasty for the treatment of femoral neck fractures

DEVICEBipolar hip hemiarthroplasty

Bipolar hip hemiarthroplasty for the treatment of femoral neck fractures

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

70 Years to No maximum

Healthy volunteers

Inclusion criteria

* Displaced femoral neck fracture * 70 years or older * Ambulatory status: No walking aids * No mental illness or impaired cognitive function

Exclusion criteria

* Pathological fracture (malignant disease) * Ongoing systemic or local infection * Radiologically presence of acetabular wear (osteoarthrosis)

Design outcomes

Primary

Measure	Time frame
Acetabular wear measured with radiostereometry	24 months

Secondary

Measure	Time frame
Harris hip score	24 months
Health-related quality of life (eq-5d)	24 months

Countries

Norway

Outcome results

None listed

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