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

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01359540
First Posted: May 24, 2011
Last Update Posted: December 13, 2017
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 Intervention
Osteoarthritis, Hip Device: OMNI Apex Modular™ Hip Device Device: OMNI Apex ARC™ Hip Device

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 Modular™ Hip Stem And The OMNI Apex ARC™ 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: Baseline, 6 weeks, 6 months, 1, 2, 3, 4, and 5 years post-operative ]
    Change in bone mineral density (BMD) as measured by DXA imaging.


Secondary Outcome Measures:
  • Harris Hip Score (HHS) [ Time Frame: Pre-operative, 6 weeks, 6 months, 1, 2, 3, 4, and 5 years post-operative ]
    Hip functional outcomes will be assessed using the Harris Hip Score.


Enrollment: 73
Actual Study Start Date: November 2009
Estimated Study Completion Date: November 2019
Estimated Primary Completion Date: November 2019 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
APEX Modular
APEX Modular Stem group
Device: OMNI Apex Modular™ Hip Device
ARC Stem
ARC Stem group
Device: OMNI Apex ARC™ Hip Device

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Adult patients undergoing elective total hip arthroplasty
Criteria

Inclusion Criteria:

  • Minimum age 20 years, maximum age 80 years
  • Osteoarthritis of the hip
  • Elective THA
  • Signed Informed Consent

Exclusion Criteria:

  • Osteoporosis
  • Revisions
  • Clinically obese (>40 body mass index [BMI])
  • Femoral dysplasia
  • Trochanteric osteotomy
  • Inflammatory arthritis
  • Breast-feeding, pregnancy, or women of childbearing potential without documentation of a negative pregnancy test and not utilizing contraception
  • Patients with a history of having taken or currently taking bisphosphonates, PTH, fluoride therapy or strontium ranelate or patients taking other chronic medications that in the investigator's opinion are known to affect bone mineral density in a substantial way
  • Patients with severe medical condition(s) that in the view of the investigator prohibits participation in the study
  • Use of other investigational agent in the last 30 days
  • Unable to sign Informed Consent
  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
Spokane, Washington, United States, 99218
Sponsors and Collaborators
Spokane Joint Replacement Center
Investigators
Principal Investigator: David F Scott, MD 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-OMNH
First Submitted: May 22, 2011
First Posted: May 24, 2011
Last Update Posted: December 13, 2017
Last Verified: December 2017

Keywords provided by David F. Scott, MD, Spokane Joint Replacement Center:
Total Hip Arthroplasty
Bone Loss
Femoral Remodeling
Bone mineral density
THA
DXA
DEXA
Dual Energy X-Ray Absorptiometry

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