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

Study Overview
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Brief Summary
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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.

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

Conditions
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Hip Pain

Intervention / Treatment
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* Other: Blood levels drawn


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Preoperative Group<br>This is a group of 30 patients who will be undergoing a total hip replacement with a Trident II shell. This group of patients will have their bloods drawn and tested for metal ion levels at a preoperative visit. | Other: Blood levels drawn<br>* 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.<br>|
| Other: 1 year Postoperative Group<br>This is the same group of 30 patients who are now one year post op after having a total hip replacement with a Trident II shell. This group of patients will have their bloods drawn and tested for metal ion levels at their one year visit. | Other: Blood levels drawn<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Metal Ion levels before and 1 year after a total hip replacement with a Trident II Cup | 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. | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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metal ion levels, total hip replacement, Trident II cup.