Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2012 by Spokane Joint Replacement Center
Information provided by (Responsible Party):
David F. Scott, MD, Spokane Joint Replacement Center Identifier:
First received: May 22, 2011
Last updated: December 12, 2012
Last verified: December 2012

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

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 Spokane Joint Replacement Center:

Primary Outcome Measures:
  • Femoral bone mineral density [ Time Frame: 5 years ] [ Designated as safety issue: No ]

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)
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.


Ages Eligible for Study:   up to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

Adult patients undergoing THA


Inclusion Criteria: see protocol


  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01359540

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

No publications provided

Responsible Party: David F. Scott, MD, Principle Investigator, Spokane Joint Replacement Center Identifier: NCT01359540     History of Changes
Other Study ID Numbers: SJRC-OMNI Hip
Study First Received: May 22, 2011
Last Updated: December 12, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Spokane Joint Replacement Center:
Total Hip Arthroplasty
Bone Loss
Femoral Remodeling

Additional relevant MeSH terms:
Osteoarthritis, Hip
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases processed this record on March 03, 2015