Bone Mineral Changes Around Stemless and Stemmed Cementless Femoral Components

This study has been completed.
Sponsor:
Information provided by:
Ewha Womans University
ClinicalTrials.gov Identifier:
NCT00957970
First received: July 21, 2009
Last updated: August 12, 2009
Last verified: August 2009

July 21, 2009
August 12, 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 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00957970 on ClinicalTrials.gov Archive Site
Harris hip score [ Time Frame: 2 years ] [ Designated as safety issue: No ]
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.

Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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 ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
120
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.
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
NCT00957970
2009-7-17
Yes
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