Metal Ion Levels in Stryker Trident II Tritanium System With Modular Dual Mobility (MDM) Liner, Ceramic Head, and SecurFit Advanced Stems
| Status: | Enrolling by invitation |
|---|---|
| Healthy: | No |
| Age Range: | 21 - 80 |
| Updated: | 4/17/2018 |
| Start Date: | February 22, 2018 |
| End Date: | May 26, 2019 |
Metal Ion Levels in Stryker Trident II Tritanium System With 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.
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.
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
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