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

Sykehuset Asker og Baerum

Status: Completed

Conditions: Hip Fractures

Treatments: Device: Unipolar hip hemiarthroplasty; Device: Bipolar hip hemiarthroplasty

Study type: Interventional

Funder types: Other

Identifiers

NCT00746876

HEMI-UNI-BIPOL

Details and patient eligibility

About

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.

Full 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.

Enrollment: 28 patients

Sex: All

Ages: 70+ years old

Volunteers: No 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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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28 participants in 2 patient groups

Unipolar

Active Comparator group

Description:

15 patients randomized for treatment with a unipolar hip hemiarthroplasty

Treatment:

Device: Unipolar hip hemiarthroplasty

Bipolar

Active Comparator group

Description:

15 patients randomized for treatment with a bipolar hip hemiarthroplasty

Treatment:

Device: Bipolar hip hemiarthroplasty