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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified February 2007 by Ullevaal University Hospital.
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00607516
First Posted: February 5, 2008
Last Update Posted: June 24, 2009
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.
Information provided by:
Ullevaal University Hospital
  Purpose

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


Condition Intervention
Femoral Neck Fractures Bone Density Acetabular Wear Hemiarthroplasty Procedure: Cemented primary bipolar hemiarthroplasty of the hip Procedure: Uncemented primary bipolar hemiarthroplasty of the hip

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Radiostereometric Analysis of Acetabular Wear and Periprosthetic Bone Mineral Density Changes in Cemented and Uncemented Hemiarthroplasties for Femoral Neck Fractures

Resource links provided by NLM:


Further study details as provided by Ullevaal University Hospital:

Primary Outcome Measures:
  • Acetabular wear in mm [ Time Frame: 1 year ]
  • Loss of bone mineral density (BMD) [ Time Frame: 1 year ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 22
Study Start Date: March 2006
Estimated Study Completion Date: January 2009
Estimated Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Cemented
Cemented primary bipolar hemiarthroplasty of the hip
Procedure: Cemented primary bipolar hemiarthroplasty of the hip
Cemented primary bipolar hemiarthroplasty of the hip
Other Name: Spectron, Smith & Nephew, Memphis, TN
Active Comparator: Uncemented
Uncemented primary bipolar hemiarthroplasty of the hip
Procedure: Uncemented primary bipolar hemiarthroplasty of the hip
Uncemented primary bipolar hemiarthroplasty of the hip
Other Name: Corail, DePuy/Johnson and Johnson, United Kingdom

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Cognitive dysfunction
  • Infection
  • Fracture caused by malignant disease
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00607516


Locations
Norway
Ullevål University Hospital
Oslo, Norway, 0407
Sponsors and Collaborators
Ullevaal University Hospital
Investigators
Study Director: Lars Nordsletten, Prof MD PhD Ullevål University Hospital, University of Oslo
  More Information

Responsible Party: Lars Nordsletten, Ulleval university hospital
ClinicalTrials.gov Identifier: NCT00607516     History of Changes
Other Study ID Numbers: HEMI-RSA-DEXA
REK I (Norway) 151-05-04061
First Submitted: January 22, 2008
First Posted: February 5, 2008
Last Update Posted: June 24, 2009
Last Verified: February 2007

Keywords provided by Ullevaal University Hospital:
fracture
arthroplasty
wear
osteoporosis
bone

Additional relevant MeSH terms:
Fractures, Bone
Femoral Neck Fractures
Wounds and Injuries
Hip Fractures
Femoral Fractures
Hip Injuries
Leg Injuries