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

April 25, 2019 updated by: David F. Scott, MD, Spokane Joint Replacement Center

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

73

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Washington
      • Spokane, Washington, United States, 99218
        • Spokane Joint Replacement Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Adult patients undergoing elective total hip arthroplasty

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
APEX Modular
APEX Modular Stem group
Device: OMNI Apex Modular™ Hip Device
ARC Stem
ARC Stem group
Device: OMNI Apex ARC™ Hip Device

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline, 6 weeks, 6 months, 1, 2, 3, 4, and 5 years post-operative

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Pre-operative, 6 weeks, 6 months, 1, 2, 3, 4, and 5 years post-operative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Spokane Joint Replacement Center

Investigators

  • Principal Investigator: David F Scott, MD, Spokane Joint Replacement Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2009

Primary Completion (Actual)

April 1, 2018

Study Completion (Actual)

April 1, 2018

Study Registration Dates

First Submitted

May 22, 2011

First Submitted That Met QC Criteria

May 23, 2011

First Posted (Estimate)

May 24, 2011

Study Record Updates

Last Update Posted (Actual)

April 26, 2019

Last Update Submitted That Met QC Criteria

April 25, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SJRC-OMNH

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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