A Prospective RSA and Clinical Evaluation of the Trident II Acetabular Cup

Status unconfirmed · Not applicable

Conditions studied: Total Hip Arthroplasty, Acetabular Cup

In brief

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 Trident II Acetabular Cup.

Key facts

Study ID

NCT03261986

Run by

Midwest Orthopaedics at Rush

People needed

50

Starts

2017-06-09

Expected to finish

2022-02-09

Last updated by the study team

2020-03-17

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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 -

You may not qualify if…

• 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 -

Where it is running

• Midwest Orthopaedics at Rush — Naperville, Illinois, United States

Full record on ClinicalTrials.gov

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