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

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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

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


Condition or disease Intervention/treatment Phase
Femoral Neck Fractures Bone Density Acetabular Wear Hemiarthroplasty Procedure: Cemented primary bipolar hemiarthroplasty of the hip Procedure: Uncemented primary bipolar hemiarthroplasty of the hip Not Applicable

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 : Interventional  (Clinical Trial)
Actual Enrollment : 22 participants
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
Study Start Date : March 2006
Estimated Primary Completion Date : January 2009
Estimated Study Completion Date : January 2009

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




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

Secondary Outcome Measures :
  1. Functional outcome including pain (Harris Hip Score) [ Time Frame: 1 year ]
  2. Activities Of Daily Living (Barthels ADL-Index) [ Time Frame: 1 year ]
  3. Quality Of Life (EQ-5D) [ Time Frame: 1 year ]


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Ages Eligible for Study:   65 Years and older   (Older Adult)
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

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

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 Posted: February 5, 2008    Key Record Dates
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