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

Chronic Hip Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03469817
• Other study ID #: 2017-1570
• Status: Completed
• Phase: N/A
• Start date: February 26, 2018
• Est. completion date: May 26, 2021

Study information

• Verified date: August 2021
• Source: Hospital for Special Surgery, New York
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: May 26, 2021
• Est. primary completion date: May 26, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Hip Pain

Intervention

Diagnostic Test:
• MRI
Patients who are part of "Arm 2" will undergo an MRI at their 1 year post-operative visit.

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	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