Maveric Magnetic Resonance Imaging Used to Study Detailed Bone Apposition and Fixation of the Stryker Trident II Tritanium System

August 20, 2021 updated by: Hospital for Special Surgery, New York
The study aims to describe bone apposition and fixation of the Trident and Trident II Tritatnium acetabular system in patients 1 year status post total hip replacement. We will be studying this by comparing magnetic resonance imaging (MRI)s taken 1 year s/p total hip replacement with a Trident II cup with MRI's taken of patients with the Trident Cup who had MRIs done at 1 year post-op.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Patients who had a primary total hip replacement with a Stryker Trident II acetabular cup that have one year or more follow up.
  2. Patients that are willing able able to have an MRI at their one year follow up visit.
  3. Patients entered into the CORRe database (our HSS institutional joint replacement registry).

Exclusion Criteria:

  1. Patients who have not been consented as part of the CORRe database.
  2. Patients who are unable or refuse to have an MRI at their 1 year follow up.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Patients who have undergone THR with Trident Cup
Patients who have had THR with Trident Cups and have previously had an MRI taken at the Hospital for Special Surgery at 1 year post-op.
Other: Patients who have undergone THR with Trident II Cup
Patients who have had THR with Trident II Cups and will have an MRI taken at their one year post-operative visit.
Diagnostic test: MRI
Patients who are part of "Arm 2" will undergo an MRI at their 1 year post-operative visit.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Comparison of bone apposition and fixation in patients with the Trident II Tritanium hip system with bone apposition and fixation in patients with Trident cups.
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital for Special Surgery, New York

Collaborators

Stryker Nordic

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 26, 2018

Primary Completion (Actual)

May 26, 2021

Study Completion (Actual)

May 26, 2021

Study Registration Dates

First Submitted

February 9, 2018

First Submitted That Met QC Criteria

March 12, 2018

First Posted (Actual)

March 19, 2018

Study Record Updates

Last Update Posted (Actual)

August 23, 2021

Last Update Submitted That Met QC Criteria

August 20, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2017-1570

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

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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