NCT01359540
Completed
N/A
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
Spokane Joint Replacement Center1 site in 1 country73 target enrollmentNovember 2009
ConditionsOsteoarthritis, Hip
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Osteoarthritis, Hip
- Sponsor
- Spokane Joint Replacement Center
- Enrollment
- 73
- Locations
- 1
- Primary Endpoint
- Femoral bone mineral density
- Status
- Completed
- Last Updated
- 7 years ago
Overview
Brief Summary
This study compares the change in bone density which occurs after hip replacement with different femoral stem devices.
Investigators
David F. Scott, MD
Principle Investigator
Spokane Joint Replacement Center
Eligibility Criteria
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
Outcomes
Primary Outcomes
Femoral bone mineral density
Time Frame: 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 Outcomes
- Harris Hip Score (HHS)(Pre-operative, 6 weeks, 6 months, 1, 2, 3, 4, and 5 years post-operative)
Study Sites (1)
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