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

Osteoarthritis, Hip Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01359540
• Other study ID #: SJRC-OMNH
• Status: Completed
• Start date: November 2009
• Est. completion date: April 2018

Study information

• Verified date: April 2019
• Source: Spokane Joint Replacement Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 73
• Est. completion date: April 2018
• Est. primary completion date: April 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis, Hip

Intervention

Device:
• OMNI Apex Modular™ Hip Device

• OMNI Apex ARC™ Hip Device

Locations

Country	Name	City	State
United States	Spokane Joint Replacement Center	Spokane	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Spokane Joint Replacement Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Femoral bone mineral density	Change in bone mineral density (BMD) as measured by DXA imaging.	Baseline, 6 weeks, 6 months, 1, 2, 3, 4, and 5 years post-operative
Secondary	Harris Hip Score (HHS)	Hip functional outcomes will be assessed using the Harris Hip Score.	Pre-operative, 6 weeks, 6 months, 1, 2, 3, 4, and 5 years post-operative