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

Hip Fractures Clinical Trial

— HEMIUNIBIPOL  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00746876
• Other study ID #: HEMI-UNI-BIPOL
• Status: Completed
• Phase: N/A
• First received: September 3, 2008
• Last updated: April 18, 2016
• Start date: September 2009
• Est. completion date: December 2015

Study information

• Verified date: April 2016
• Source: Sykehuset Asker og Baerum
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway: Norwegian Institute of Public HealthNorway: Directorate of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: December 2015
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 70 Years and older

Eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Femoral Neck Fractures
• Fractures, Bone
• Hip Fractures

Intervention

Device:
• Unipolar hip hemiarthroplasty
Unipolar hip hemiarthroplasty for the treatment of femoral neck fractures
• Bipolar hip hemiarthroplasty
Bipolar hip hemiarthroplasty for the treatment of femoral neck fractures

Locations

Country	Name	City	State
Norway	Asker and Baerum Hospital	Baerum	Rud

Sponsors (2)

Lead Sponsor	Collaborator
Sykehuset Asker og Baerum	Ullevaal University Hospital

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Acetabular wear measured with radiostereometry		24 months	No
Secondary	Harris hip score		24 months	No
Secondary	Health-related quality of life (eq-5d)		24 months	No