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

Hospital for Special Surgery, New York30 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Hip Pain

Interventions

Eligibility

Sex: ALLMin age: 21 YearsMax age: 80 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: 1. Patients who will be undergoing a total hip replacement with a Stryker Trident II cup 2. Patients have signed an Institutional Review Board (IRB) approved consent form 3. Patient is 21-80 4. Patient has a diagnosis of Non-Inflammatory Degenerative Joint Disease 5. Patient is willing and able to comply with postoperative scheduled clinical evaluations. Exclusion Criteria: 1. Patients who have not been consented as part of the Collaborative Orthopaedic Replacement Registry (CORRe) database 2. Patients with other joint replacements (shoulder/knee) 3. Patients with bilateral hip replacements 4. Prisoners 5. International Patients

Outcomes

Primary Outcomes

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.

Time frame: 1 year