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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

73 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-11-30

Study Completion Date

2018-04-30

Brief Summary

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

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Detailed Description

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Conditions

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Osteoarthritis, Hip

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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APEX Modular

APEX Modular Stem group

OMNI Apex Modular™ Hip Device

Intervention Type DEVICE

ARC Stem

ARC Stem group

OMNI Apex ARC™ Hip Device

Intervention Type DEVICE

Interventions

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OMNI Apex Modular™ Hip Device

Intervention Type DEVICE

OMNI Apex ARC™ Hip Device

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes