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Bone Mineral Changes Around Stemless and Stemmed Cementless Femoral Components

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

Condition Intervention Phase
Osteoarthritis of Hip
Device: Stemless femoral component
Device: IPS, Depuy cementless femoral stem
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Periprosthetic Bone Mineral Changes Around Stemless and Stemmed Cementless Femoral Components

Resource links provided by NLM:

Further study details as provided by Ewha Womans University:

Primary Outcome Measures:
  • Bone mineral density of surrounding proximal femur according to Gruen zones [ Time Frame: At least 2years after surgery ]

Secondary Outcome Measures:
  • Harris hip score [ Time Frame: 2 years ]

Enrollment: 120
Study Start Date: July 2006
Study Completion Date: July 2009
Primary Completion Date: July 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Stemless femoral component
Stemless PROXIMA femoral component
Device: Stemless femoral component
Total hip femoral component anatomically designed for a proximal fit without a stem
Other Name: PROXIMA, DePuy stem,
Active Comparator: Stemmed femoral component
IPS, proximal anatomical fit stemmed femoral component
Device: IPS, Depuy cementless femoral stem
Anatomical proximal fitted cementless stemmed femoral component
Other Name: IPS, Depuy anatomical proximal fit stemmed femoral component

Detailed Description:
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.

Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.
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Please refer to this study by its identifier: NCT00957970

Korea, Republic of
Ewha Womans University Mokdong Hospital
Seoul, Korea, Republic of
Sponsors and Collaborators
Ewha Womans University
Study Director: Young-Hoo Kim, MD Korean Joint replacement Center
  More Information