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

Study Overview
=================
Brief Summary
-----------------
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.

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

Conditions
-----------------
Chronic Hip Pain

Intervention / Treatment
-----------------
* Diagnostic Test: MRI


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who had a primary total hip replacement with a Stryker Trident II acetabular cup that have one year or more follow up. Patients that are willing able able to have an MRI at their one year follow up visit. Patients entered into the CORRe database (our HSS institutional joint replacement registry). Exclusion Criteria: Patients who have not been consented as part of the CORRe database. Patients who are unable or refuse to have an MRI at their 1 year follow up.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Other
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 1 control group who have had been implanted with a Trident cup and have already had MRIs taken at their one year post-operative visit. This group's MRI's will be compared with MRI's from Tridend II patients who have had MRI's at 1 year post-operative visit.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Patients who have undergone THR with Trident Cup<br>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<br>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<br>* Patients who are part of Arm 2 will undergo an MRI at their 1 year post-operative visit.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | 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. |  | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Bone apposition, Stryker, MRI, Trident II, Total Hip Replacement