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Active Not Recruiting NCT02999009

Trident II Tritanium Acetabular Shell Outcomes Study

Conditions: Arthroplasty, Replacement, Hip

Sex: All
Ages: 18 Years – 80 Years
Healthy volunteers: No
Phase: NA
Enrollment: 383
Sponsor: Stryker Orthopaedics

Location: Tucson Orthopaedic Institute Tucson Arizona

Summary

The purpose of this study is to review the performance and success rate of an FDA approved cementless hip replacement part called the Trident II Tritanium Acetabular Shell. The study will specifically look at the need to revise the hip replacement after 5 years. This will be compared to how much this happens in patients who have hip replacement with similar cementless acetabular shells.

Eligibility Criteria

Inclusion Criteria: A. Patient has signed an Institutional Review Board (IRB) approved, study specific Informed Patient Consent Form. B. Patient is a male or non-pregnant female age 18-80 years of age at the time of study device implantation. C. Patient has primary diagnosis of Non-Inflammatory Degenerative Joint Disease. D. Patient is a candidate for a primary cementless total hip replacement. E. Patient is willing and able to comply with postoperative scheduled clinical and radiographic evaluations. Exclusion Criteria: F. Patient has a Body Mass Index (BMI) ≥ 40. G. Patient is diagnosed with Inflammatory Arthritis. H. Patient has an active or suspected latent infection in or about the affected hip joint at time of study device implantation. I. Patient has a neuromuscular or neurosensory deficiency, which limits the ability to evaluate the safety and efficacy of the device. J. Patient is diagnosed with a systemic disease (e.g. Lupus Erythematosus) or a metabolic disorder (e.g. Paget's Disease) leading to progressive bone deterioration. K. Patient is immunologically suppressed or receiving steroids in excess of normal physiological requirements (e.g. \> 30 days). L. Patient requires revision surgery of a previously implanted total hip replacement or hip fusion to the affected joint. M. Patient has had previous open surgery to the affected joint, not including arthroscopy. N. Patient requires implantation of a constrained liner. O. Patient has a known sensitivity to device materials. P. Patient is a prisoner.

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT02999009). StuddyBuddy aggregates publicly available trial information.