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Completed

NCT Number: NCT01359527

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

This study compares the change (loss) of bone mineral density (BMD) that occurs in the proximal femur after hip resurfacing and total hip replacement.

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Key information

Conditions

Osteoarthritis, Hip Arthritis Bone Diseases Bone Diseases, Metabolic Joint Diseases Metabolic Diseases Musculoskeletal Diseases Nutritional and Metabolic Diseases Osteoarthritis Rheumatic Diseases

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Spokane Joint Replacement Center

Spokane, Washington, 99218, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Hip Resurfacing

Device

Total hip arthroplasty

Device

Primary outcomes

  1. 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 outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Spokane Joint Replacement Center

Other

Registry information

Official study title

A Dual Energy X-Ray Absorptiometry Comparison Of Periprosthetic Bone Loss Between Patients Undergoing Hip Resurfacing Surgery And Total Hip Arthroplasty

Important dates

Study start
2008
Primary completion
2018
Study completion
2018
First posted
May 24, 2011
Registry last updated
Apr 26, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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