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Dual Energy X-ray Absorptiometry (DXA) Comparison Hip Resurfacing Versus Total Hip Arthroplasty (THA)

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01359527
First Posted: May 24, 2011
Last Update Posted: December 13, 2017
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 (Responsible Party):
David F. Scott, MD, Spokane Joint Replacement Center
  Purpose
This study compares the change (loss) of bone mineral density (BMD) that occurs in the proximal femur after hip resurfacing and total hip replacement.

Condition Intervention
Osteoarthritis, Hip Device: Hip Resurfacing Device: Total Hip Arthroplasty

Study Type: Observational
Study Design: Observational Model: Case-Control
Time Perspective: Prospective
Official Title: A Dual Energy X-Ray Absorptiometry Comparison Of Periprosthetic Bone Loss Between Patients Undergoing Hip Resurfacing Surgery And Total Hip Arthroplasty

Resource links provided by NLM:


Further study details as provided by David F. Scott, MD, Spokane Joint Replacement Center:

Primary Outcome Measures:
  • Bone Mineral Density [ Time Frame: Baseline, 6 weeks, 6 months, 1, 2, 3, 4, and 5 years post-operative ]
    To evaluate the bone loss in the proximal femur resulting from hip resurfacing surgery and to compare this to the bone loss in the proximal femur resulting from total hip arthroplasty.


Secondary Outcome Measures:
  • Harris Hip Score [ Time Frame: Pre-operative, 6 weeks, 6 months, 1, 2, 3, 4, and 5 years post-operative ]
    Hip functional outcomes will be assessed using the Harris Hip Score


Enrollment: 31
Study Start Date: December 2008
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: December 2018 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Hip Resurfacing Device: Hip Resurfacing
Total Hip Arthroplasty Device: Total Hip Arthroplasty

Detailed Description:
This study compares the change (loss) of bone mineral density (BMD) that occurs in the proximal femur after hip resurfacing and total hip replacement. The goal is to evaluate the bone loss in the proximal femur resulting from hip resurfacing surgery and to compare this to the bone loss in the proximal femur resulting from total hip arthroplasty.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Adult patients undergoing hip replacement or resurfacing for osteoarthritis
Criteria

Inclusion Criteria:

  • Age of at least 20 years
  • Osteoarthritis
  • Elective Total Hip Arthroplasty / Resurfacing
  • Signed Informed Consent

Exclusion Criteria:

  • Osteoporosis
  • Revisions
  • Femoral dysplasia
  • Trochanteric osteotomy
  • Inflammatory arthritis
  • Breast-feeding, pregnancy, or women of child-bearing potential without documentation of a negative pregnancy test and not utilizing contraception
  • Patients with a history of having taken or currently taking PTH, fluoride therapy or strontium ranelate or patients taking other chronic medications that in the Investigator's opinion are known to affect bone mineral density in a substantial way
  • Patients with severe medical condition(s) that in the view of the Investigator prohibits participation in the study
  • Use of any other investigational agent in the last 30 days
  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): NCT01359527


Locations
United States, Washington
Spokane Joint Replacement Center
Spokane, Washington, United States, 99218
Sponsors and Collaborators
Spokane Joint Replacement Center
Investigators
Principal Investigator: David Scott, MD Spokane Joint Replacement Center
  More Information

Responsible Party: David F. Scott, MD, PI, Spokane Joint Replacement Center
ClinicalTrials.gov Identifier: NCT01359527     History of Changes
Other Study ID Numbers: SJRC-RSRF
First Submitted: May 22, 2011
First Posted: May 24, 2011
Last Update Posted: December 13, 2017
Last Verified: December 2017

Keywords provided by David F. Scott, MD, Spokane Joint Replacement Center:
Total Hip Replacement
Hip Resurfacing
Femoral Remodeling
Bone Loss
Bone Mineral Density
BMD
DXA
DEXA
THA

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Hip
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases