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
1 other identifier
observational
73
1 country
1
Brief Summary
This study compares the change in bone density which occurs after hip replacement with different femoral stem devices.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Nov 2009
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2009
CompletedFirst Submitted
Initial submission to the registry
May 22, 2011
CompletedFirst Posted
Study publicly available on registry
May 24, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2018
CompletedApril 26, 2019
April 1, 2019
8.4 years
May 22, 2011
April 25, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Harris Hip Score (HHS)
Pre-operative, 6 weeks, 6 months, 1, 2, 3, 4, and 5 years post-operative
Study Arms (2)
APEX Modular
APEX Modular Stem group
ARC Stem
ARC Stem group
Interventions
Eligibility Criteria
Adult patients undergoing elective total hip arthroplasty
You may qualify if:
- Minimum age 20 years, maximum age 80 years
- Osteoarthritis of the hip
- Elective THA
- Signed Informed Consent
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Spokane Joint Replacement Center
Spokane, Washington, 99218, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
David F Scott, MD
Spokane Joint Replacement Center
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principle Investigator
Study Record Dates
First Submitted
May 22, 2011
First Posted
May 24, 2011
Study Start
November 1, 2009
Primary Completion
April 1, 2018
Study Completion
April 1, 2018
Last Updated
April 26, 2019
Record last verified: 2019-04