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

Brief Summary:
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 or disease Intervention/treatment Phase
Osteoarthritis of Hip Device: Stemless femoral component Device: IPS, Depuy cementless femoral stem Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Periprosthetic Bone Mineral Changes Around Stemless and Stemmed Cementless Femoral Components
Study Start Date : July 2006
Actual Primary Completion Date : July 2007
Actual Study Completion Date : July 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Minerals

Arm Intervention/treatment
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




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

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


Information from the National Library of Medicine

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

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.

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): NCT00957970


Locations
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Korea, Republic of
Ewha Womans University Mokdong Hospital
Seoul, Korea, Republic of
Sponsors and Collaborators
Ewha Womans University
Investigators
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Study Director: Young-Hoo Kim, MD Korean Joint replacement Center
Publications:
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Responsible Party: Young-Hoo, Kim M.D., Ewha Womans University Mokdong Hospital Joint Replacement Center
ClinicalTrials.gov Identifier: NCT00957970    
Other Study ID Numbers: 2009-7-17
First Posted: August 13, 2009    Key Record Dates
Last Update Posted: August 13, 2009
Last Verified: August 2009
Keywords provided by Ewha Womans University:
Stress shielding
Bone mineral density
stemless femoral component
Additional relevant MeSH terms:
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Osteoarthritis, Hip
Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases