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Radiostereometric Analysis of Acetabular Wear and Periprosthetic Bone Mineral Density Changes in Hemiarthroplasties (HEMI-RSADEXA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00607516
Recruitment Status : Unknown
Verified February 2007 by Ullevaal University Hospital.
Recruitment status was:  Active, not recruiting
First Posted : February 5, 2008
Last Update Posted : June 24, 2009
Sponsor:
Information provided by:
Ullevaal University Hospital

Tracking Information
First Submitted Date  ICMJE January 22, 2008
First Posted Date  ICMJE February 5, 2008
Last Update Posted Date June 24, 2009
Study Start Date  ICMJE March 2006
Estimated Primary Completion Date January 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 22, 2008)
  • Acetabular wear in mm [ Time Frame: 1 year ]
  • Loss of bone mineral density (BMD) [ Time Frame: 1 year ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 22, 2008)
  • Functional outcome including pain (Harris Hip Score) [ Time Frame: 1 year ]
  • Activities Of Daily Living (Barthels ADL-Index) [ Time Frame: 1 year ]
  • Quality Of Life (EQ-5D) [ Time Frame: 1 year ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Radiostereometric Analysis of Acetabular Wear and Periprosthetic Bone Mineral Density Changes in Hemiarthroplasties
Official Title  ICMJE Radiostereometric Analysis of Acetabular Wear and Periprosthetic Bone Mineral Density Changes in Cemented and Uncemented Hemiarthroplasties for Femoral Neck Fractures
Brief 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

Detailed 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Femoral Neck Fractures
  • Bone Density
  • Acetabular Wear
  • Hemiarthroplasty
Intervention  ICMJE
  • Procedure: Cemented primary bipolar hemiarthroplasty of the hip
    Cemented primary bipolar hemiarthroplasty of the hip
    Other Name: Spectron, Smith & Nephew, Memphis, TN
  • Procedure: Uncemented primary bipolar hemiarthroplasty of the hip
    Uncemented primary bipolar hemiarthroplasty of the hip
    Other Name: Corail, DePuy/Johnson and Johnson, United Kingdom
Study Arms  ICMJE
  • Active Comparator: Cemented
    Cemented primary bipolar hemiarthroplasty of the hip
    Intervention: Procedure: Cemented primary bipolar hemiarthroplasty of the hip
  • Active Comparator: Uncemented
    Uncemented primary bipolar hemiarthroplasty of the hip
    Intervention: Procedure: Uncemented primary bipolar hemiarthroplasty of the hip
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Actual Enrollment  ICMJE
 (submitted: January 22, 2008)
22
Original Actual Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 2009
Estimated Primary Completion Date January 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Femoral neck fracture
  • 65 years or older
  • Able to walk independently

Exclusion Criteria:

  • Cognitive dysfunction
  • Infection
  • Fracture caused by malignant disease
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 65 Years and older   (Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Norway
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00607516
Other Study ID Numbers  ICMJE HEMI-RSA-DEXA
REK I (Norway) 151-05-04061
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Lars Nordsletten, Ulleval university hospital
Study Sponsor  ICMJE Ullevaal University Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Lars Nordsletten, Prof MD PhD Ullevål University Hospital, University of Oslo
PRS Account Ullevaal University Hospital
Verification Date February 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP