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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 because the information has not been verified recently.
Verified February 2007 by Ullevaal University Hospital.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Ullevaal University Hospital
ClinicalTrials.gov Identifier:
NCT00607516
First received: January 22, 2008
Last updated: June 23, 2009
Last verified: February 2007
History of Changes
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (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:

U.S. FDA Resources

Further study details as provided by Ullevaal University Hospital:

Primary Outcome Measures:
  • Acetabular wear in mm [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Loss of bone mineral density (BMD) [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Functional outcome including pain (Harris Hip Score) [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Activities Of Daily Living (Barthels ADL-Index) [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Quality Of Life (EQ-5D) [ Time Frame: 1 year ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: January 22, 2008
Last Updated: June 23, 2009
Health Authority: Norway:National Committee for Medical and Health Research Ethics

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

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

ClinicalTrials.gov processed this record on May 19, 2013