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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Hip Pain
• Intervention / Treatment: Other: Blood levels drawn

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10021
      • Hospital for Special Surgery

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Preoperative Group; 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; 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.
Other: 1 year Postoperative Group; 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; 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Hospital for Special Surgery, New York
• Collaborators: Stryker Nordic

Study record dates

Study Major Dates

• Study Start (Actual): February 22, 2018
• Primary Completion (Estimated): January 11, 2024
• Study Completion (Estimated): January 11, 2024

Study Registration Dates

• First Submitted: February 8, 2018
• First Submitted That Met QC Criteria: February 14, 2018
• First Posted (Actual): February 15, 2018

Study Record Updates

• Last Update Posted (Actual): July 3, 2023
• Last Update Submitted That Met QC Criteria: June 29, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: metal ion levels, total hip replacement, Trident II cup.
• Other Study ID Numbers: 2017-1567

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No