Radiostereometric Analysis of Acetabular Wear and Periprosthetic Bone Mineral Density Changes in Hemiarthroplasties

Femoral Neck Fractures Clinical Trial

— HEMI-RSADEXA  

Official title:

Radiostereometric Analysis of Acetabular Wear and Periprosthetic Bone Mineral Density Changes in Cemented and Uncemented Hemiarthroplasties for Femoral Neck Fractures

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00607516
• Other study ID #: HEMI-RSA-DEXA
• Secondary ID: REK I (Norway) 1
• Status: Active, not recruiting
• Phase: N/A
• First received: January 22, 2008
• Last updated: June 23, 2009
• Start date: March 2006
• Est. completion date: January 2009

Study information

• Verified date: February 2007
• Source: Ullevaal University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway:National Committee for Medical and Health Research Ethics
• Study type: Interventional

Clinical Trial Summary

Substudy and continuation of HEMI-SAB-UUS (NCT00491673)

Study on radiostereometric measurements of acetabular wear in bipolar hemiarthroplasties and measurements of periprosthetic bone mineral density in cemented and uncemented hemiarthroplasties in patients with femoral neck fractures.

Null hypothesis: No difference in acetabular wear or in bone mineral density changes between cemented and uncemented hemiarthroplasties

Description:

Patients are randomised to treatment with cemented or uncemented bipolar hemiarthroplasty. 1mm tantalum markers are inserted in the pelvis during surgery. RSA X-rays and DEXA measurements conducted postoperatively, after 3 and 12 months. Follow-up visits and clinical examination at 3 and 12 months.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 22
• Est. completion date: January 2009
• Est. primary completion date: January 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 65 Years and older

Eligibility

Inclusion Criteria:

• Femoral neck fracture

• 65 years or older

• Able to walk independently

Exclusion Criteria:

• Cognitive dysfunction

• Infection

• Fracture caused by malignant disease

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acetabular Wear
• Bone Density
• Femoral Neck Fractures
• Hemiarthroplasty

Intervention

Procedure:
• Cemented primary bipolar hemiarthroplasty of the hip
Cemented primary bipolar hemiarthroplasty of the hip
• Uncemented primary bipolar hemiarthroplasty of the hip
Uncemented primary bipolar hemiarthroplasty of the hip

Locations

Country	Name	City	State
Norway	Ullevål University Hospital	Oslo

Sponsors (1)

Lead Sponsor	Collaborator
Ullevaal University Hospital

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Acetabular wear in mm		1 year	No
Primary	Loss of bone mineral density (BMD)		1 year	No
Secondary	Functional outcome including pain (Harris Hip Score)		1 year	No
Secondary	Activities Of Daily Living (Barthels ADL-Index)		1 year	No
Secondary	Quality Of Life (EQ-5D)		1 year	No