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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01359540

Enrollment

Registered

2011-05-24

Start date

2009-11-30

Completion date

2018-04-30

Last updated

2019-04-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteoarthritis, Hip

Keywords

Total Hip Arthroplasty, Bone Loss, Femoral Remodeling, Bone mineral density, THA, DXA, DEXA, Dual Energy X-Ray Absorptiometry

Brief summary

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

Interventions

DEVICEOMNI Apex Modular™ Hip Device

DEVICEOMNI Apex ARC™ Hip Device

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

20 Years to 80 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Femoral bone mineral density	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

Measure	Time frame	Description
Harris Hip Score (HHS)	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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026