Bone Mineral Changes Around Stemless and Stemmed Cementless Femoral Components

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. Identifier: NCT00957970
Recruitment Status : Completed
First Posted : August 13, 2009
Last Update Posted : August 13, 2009
Information provided by:
Ewha Womans University

July 21, 2009
August 13, 2009
August 13, 2009
July 2006
July 2007   (Final data collection date for primary outcome measure)
Bone mineral density of surrounding proximal femur according to Gruen zones [ Time Frame: At least 2years after surgery ]
Same as current
No Changes Posted
Harris hip score [ Time Frame: 2 years ]
Same as current
Not Provided
Not Provided
Bone Mineral Changes Around Stemless and Stemmed Cementless Femoral Components
Periprosthetic Bone Mineral Changes Around Stemless and Stemmed Cementless Femoral Components
The purpose of this study is to determine if there is a difference in stress shielding and bone resorption of the proximal femur in two anatomical stem total hip designs.
Stress shielding related bone resorption in the proximal femur after total hip arthroplasty continues to be a problem. The purpose of this prospective, randomized study was to evaluate which of the two anatomical stem designs achieved a more physiological load transfer by assessing bone mineral changes in the proximal femur after stem implantation.
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Osteoarthritis of Hip
  • Device: Stemless femoral component
    Total hip femoral component anatomically designed for a proximal fit without a stem
    Other Name: PROXIMA, DePuy stem,
  • Device: IPS, Depuy cementless femoral stem
    Anatomical proximal fitted cementless stemmed femoral component
    Other Name: IPS, Depuy anatomical proximal fit stemmed femoral component
  • Active Comparator: Stemless femoral component
    Stemless PROXIMA femoral component
    Intervention: Device: Stemless femoral component
  • Active Comparator: Stemmed femoral component
    IPS, proximal anatomical fit stemmed femoral component
    Intervention: Device: IPS, Depuy cementless femoral stem

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Same as current
July 2009
July 2007   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Osteoarthritis of hip joint requiring total hip arthroplasty

Exclusion Criteria:

  • Neurologic disorders affecting motor function of lower extremity
  • foot and ankle disorders limiting ambulation of the patient
  • Patients with bone metabolic disorders other than osteoporosis which prevents normal bone metabolism
  • Multi-systemic inflammatory arthritis which debilitates patients other than hip joint.
Sexes Eligible for Study: All
Child, Adult, Senior
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
Not Provided
Not Provided
Young-Hoo, Kim M.D., Ewha Womans University Mokdong Hospital Joint Replacement Center
Ewha Womans University
Not Provided
Study Director: Young-Hoo Kim, MD Korean Joint replacement Center
Ewha Womans University
August 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP