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Femoral Remodeling Following Total Hip Arthroplasty With Omni Apex Modular™, OMNI Apex ARC™ Stem, and Omni Apex "Conical Stem" Compared to Competitive Designs

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified December 2012 by David F. Scott, MD, Spokane Joint Replacement Center.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01359540
First Posted: May 24, 2011
Last Update Posted: December 13, 2012
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.
Information provided by (Responsible Party):
David F. Scott, MD, Spokane Joint Replacement Center
  Purpose
This study compares the change in bone density which occurs after hip replacement with different femoral stem devices.

Condition
Osteoarthritis of the Hip

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: A Dual Energy X-Ray Absorptiometry (Dxa) Evaluation Of Bone Density Changes After Hip Replacement Performance Of The Omni Apex Modulartm Hip Stem And The Omni Apex Arctm Hip Stem In Primary Total Hip Arthroplasty, Five-Year Clinical And Dxa Analysis

Resource links provided by NLM:


Further study details as provided by David F. Scott, MD, Spokane Joint Replacement Center:

Primary Outcome Measures:
  • Femoral bone mineral density [ Time Frame: 5 years ]

Estimated Enrollment: 75
Study Start Date: November 2009
Estimated Study Completion Date: November 2016
Estimated Primary Completion Date: November 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts
APEX Modular
APEX Modular Stem group
ARC Stem
ARC Stem group
Conical Stem
Conical Stem group

Detailed Description:
This study compares the change in bone density which occurs after hip replacement with different femoral stem devices.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   up to 80 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Adult patients undergoing THA
Criteria

Inclusion Criteria: see protocol

  Contacts and Locations
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): NCT01359540


Locations
United States, Washington
Spokane Joint Replacement Center Recruiting
Spokane, Washington, United States, 99218
Contact: David F Scott, MD    509-466-6393    dfscott@orthospecialtyclinic.com   
Principal Investigator: David F Scott, MD         
Sponsors and Collaborators
Spokane Joint Replacement Center
  More Information

Responsible Party: David F. Scott, MD, Principle Investigator, Spokane Joint Replacement Center
ClinicalTrials.gov Identifier: NCT01359540     History of Changes
Other Study ID Numbers: SJRC-OMNI Hip
First Submitted: May 22, 2011
First Posted: May 24, 2011
Last Update Posted: December 13, 2012
Last Verified: December 2012

Keywords provided by David F. Scott, MD, Spokane Joint Replacement Center:
Total Hip Arthroplasty
Bone Loss
Femoral Remodeling

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