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

Completed

• Conditions: Osteoarthritis, Hip
• Interventions: Device: OMNI Apex Modular™ Hip Device; Device: OMNI Apex ARC™ Hip Device

• Registration Number: NCT01359540
• Lead Sponsor: Spokane Joint Replacement Center

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2009-11
• Study First Submitted: 2011-05-22
• Study First Submitted QC: 2011-05-23
• Study First Posted: 2011-05-24
• Primary Completion: 2018-04
• Study Completion: 2018-04
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-25
• Last Update Posted: 2019-04-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 73

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
APEX Modular	OMNI Apex Modular™ Hip Device	APEX Modular Stem group
ARC Stem	OMNI Apex ARC™ Hip Device	ARC Stem group

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Spokane Joint Replacement Center; 🇺🇸 Spokane, Washington, United States