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

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.

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Key information

Conditions

Hip Pain

Age range

21 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital for Special Surgery

New York, 10021, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Patients who will be undergoing a total hip replacement with a Stryker Trident II cup
Patients have signed an Institutional Review Board (IRB) approved consent form
Patient is 21-80
Patient has a diagnosis of Non-Inflammatory Degenerative Joint Disease
Patient is willing and able to comply with postoperative scheduled clinical evaluations.

Exclusion criteria

Patients who have not been consented as part of the Collaborative Orthopaedic Replacement Registry (CORRe) database
Patients with other joint replacements (shoulder/knee)
Patients with bilateral hip replacements
Prisoners
International Patients

Treatment and study plan

Blood levels drawn

Other

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.

Primary outcomes

Metal Ion levels before and 1 year after a total hip replacement with a Trident II Cup

Time frame: 1 year

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.

Sponsors and collaborators

Lead sponsor

Hospital for Special Surgery, New York

Other

Collaborators

Stryker Nordic

Registry information

Official study title

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

Important dates

Study start: 2018
Primary completion: 2024
Study completion: 2024
First posted: Feb 15, 2018
Registry last updated: Mar 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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