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



Status:Active, not recruiting
Conditions:Arthritis, Osteoarthritis (OA)
Therapuetic Areas:Rheumatology
Healthy:No
Age Range:20 - 80
Updated:12/15/2017
Start Date:November 2009
End Date:November 2019

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Trial Summary
Trial Overview
Inclusion Criteria

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.


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
We found this trial at
1
site
Spokane Joint Replacement Center
Spokane, Washington 99218
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from
Spokane, WA
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