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

Hip Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03433742
• Other study ID #: 2017-1567
• Status: Active, not recruiting
• Phase: N/A
• Start date: February 22, 2018
• Est. completion date: January 11, 2024

Study information

• Verified date: June 2023
• Source: Hospital for Special Surgery, New York
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 30
• Est. completion date: January 11, 2024
• Est. primary completion date: January 11, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Hip Pain

Intervention

Other:
• Blood 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.

Locations

Country	Name	City	State
United States	Hospital for Special Surgery	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Hospital for Special Surgery, New York	Stryker Nordic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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