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
  Purpose

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 (Subject, 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Harris hip score [ Time Frame: 2 years ] [ Designated as safety issue: No ]

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.

  Eligibility

Genders Eligible for Study:   Both
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00957970

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

Additional Information:
Publications:
Responsible Party: Young-Hoo, Kim M.D., Ewha Womans University Mokdong Hospital Joint Replacement Center
ClinicalTrials.gov Identifier: NCT00957970     History of Changes
Other Study ID Numbers: 2009-7-17
Study First Received: July 21, 2009
Last Updated: August 12, 2009
Health Authority: Korea: Food and Drug Administration

Keywords provided by Ewha Womans University:
Stress shielding
Bone mineral density
stemless femoral component

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Hip
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on April 22, 2014