NCT03433742

Metal Ion Levels in Stryker Trident II Tritanium System with Modular Dual Mobility (MDM) Liner, Ceramic Head, and SecurFit Advanced Stems

Metal Ion Levels in Stryker Trident II Tritanium System with MDM Liner, Ceramic Head, and SecurFit Advanced Stems

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Hospital for Special Surgery, New York · Academic / Other
• Sex: All
• Age: 21 Years – 80 Years
• Healthy volunteers: Accepted

Summary

Metal Ions levels of cobalt, chromium, and titanium in 40 patients preoperatively and at least 1 year status post total hip replacement with the Trident II Tritatnium system using an MDM liner and ceramic head. Are cobalt, chromium, and titanium levels in patients who undergo a total hip replacement with a Trident II Tritanium system, MDM liner, and ceramic head normal one year after surgery? Investigators expect to find normal levels of metal ions (cobalt, chromium, and titanium) after total hip replacement using Trident II Tritanium cups with an MDM liner and a ceramic head. The primary outcome (PO) is blood metal ion levels of cobalt, chromium, and titanium (concentration of metal ions in blood). Blood will be drawn in the 3rd Floor West of the Main Building, and then tested for metal ions in the Hospital for Special Surgery laboratory. The bloods will be drawn at a preoperative visit and at a one year visit.

Conditions

• Hip Pain

Interventions

Type	Name	Description
OTHER	Blood levels drawn	The patients will have their bloods drawn at the Hospital for Special Surgery during their regular, standard of care visit. The laboratory at the Hospital for Special Surgery will then test their bloods to determine the metal ion levels.

Timeline

• Start date: 2018-02-22
• Primary completion: 2024-01-11
• Completion: 2024-01-11
• First posted: 2018-02-15
• Last updated: 2025-03-17

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study