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
Sponsor:
Information provided by (Responsible Party):
David F. Scott, MD, Spokane Joint Replacement Center
ClinicalTrials.gov Identifier:
NCT01359540
First received: May 22, 2011
Last updated: December 12, 2012
Last verified: December 2012
  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 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)
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

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

Criteria

Inclusion Criteria: see protocol

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  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 ClinicalTrials.gov identifier: 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

No publications provided

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
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
Osteoarthritis, Hip
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on July 23, 2014