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CompletedNCT03433742Updated Mar 17, 2025

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

An interventional study of Blood levels drawn in Hip Pain, sponsored by Hospital for Special Surgery, New York. Completed at 1 site in United States. Open to participants aged 21 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-03-17.

Sponsored by Hospital for Special Surgery, New York · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Non-randomized
Ages
21 Years to 80 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Hip Pain

Keywords

  • metal ion levels, total hip replacement, Trident II cup.
03

Who can participate

Ages eligible
21 Years to 80 Years
Sexes eligible
All
Accepts 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

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
04

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
30 participants (actual)

Study arms

  • 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

  • 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

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.

05

What researchers measure

Primary outcomes

  1. 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

06

Study locations

1 site
  • Hospital for Special Surgery
    New York, New York 10021, United States
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03433742
Lead sponsor
Hospital for Special Surgery, New York
Collaborators
Stryker Nordic
Responsible party
Sponsor
First posted
Feb 15, 2018
Start date
Feb 22, 2018
Primary completion
Jan 11, 2024
Completion
Jan 11, 2024
Last update
Mar 17, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Nov 2024. You cannot join it, but the record below documents what was studied.

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