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

Spokane Joint Replacement Center

Status: Completed

Conditions: Osteoarthritis, Hip

Treatments: Device: OMNI Apex Modular™ Hip Device; Device: OMNI Apex ARC™ Hip Device

Study type: Observational

Funder types: Other

Identifiers

NCT01359540

SJRC-OMNH

Details and patient eligibility

About

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

Enrollment: 73 patients

Sex: All

Ages: 20 to 80 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

73 participants in 2 patient groups

APEX Modular

Description:

APEX Modular Stem group

Treatment:

Device: OMNI Apex Modular™ Hip Device

ARC Stem

Description:

ARC Stem group

Treatment:

Device: OMNI Apex ARC™ Hip Device