Status:
UNKNOWN
A Prospective RSA and Clinical Evaluation of the Trident II Acetabular Cup
Lead Sponsor:
Midwest Orthopaedics at Rush
Conditions:
Total Hip Arthroplasty
Acetabular Cup
Eligibility:
All Genders
18-85 years
Phase:
NA
Brief Summary
The objective of this study is to use radiostereometric analysis (RSA) and clinical outcome measures to evaluate early post-operative implant stability and the clinical performance of Stryker's Triden...
Detailed Description
The proposed study is a prospective evaluation of data from patients undergoing primary total hip arthroplasty using the Trident II acetabular cup. Fifty patients will be recruited for this study. All...
Eligibility Criteria
Inclusion
- Symptomatic arthritis of the hip indicating surgical intervention
- Scheduled to undergo a primary total hip arthroplasty
- Patient is a candidate for the Trident II acetabular cup in accordance with product labeling -
Exclusion
- Patients less than 18 years of age, or older than 85 years of age.
- Severe hip dysplasia (Crowe Type III or IV) in the affected hip
- History of congenital dislocation
- Prior arthroplasty of the affected hip
- Active or prior infection of the affected hip
- Morbid obesity (BMI \> 40)
- Medical condition precluding major surgery
- Severe osteoporosis
- Neuromuscular impairment
- Patients with known allergy to metals
- Pregnancy
- Patients on dialysis or creatinine \> 2.0
- Patient is immuno-suppressed -
Key Trial Info
Start Date :
June 9 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 9 2022
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT03261986
Start Date
June 9 2017
End Date
February 9 2022
Last Update
March 17 2020
Active Locations (1)
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1
Midwest Orthopaedics at Rush
Naperville, Illinois, United States, 60563