Hip Pain
Conditions
Keywords
metal ion levels, total hip replacement, Trident II cup.
Brief 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.
Interventions
OTHERBlood 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.
Sponsors
Stryker Nordic
Hospital for Special Surgery, New York
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to 80 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Metal Ion levels before and 1 year after a total hip replacement with a Trident II Cup | 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. |
Countries
United States
Outcome results
None listed