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

NCT03469817 | Completed

• 1 other identifier: 2017-1570
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Hip Pain

Keywords

Bone apposition; Stryker; MRI; Trident II; Total Hip Replacement

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Patients who have undergone THR with Trident Cup

NO INTERVENTION

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.

Patients who have undergone THR with Trident II Cup

OTHER

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

Interventions

MRI DIAGNOSTIC_TEST

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

Patients who have undergone THR with Trident II Cup

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital for Special Surgery, New York: lead
• Stryker Nordic: collaborator

Study Sites (1)

Hospital for Special Surgery

New York, New York, 10021, United States

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: February 9, 2018
• First Posted: March 19, 2018
• Study Start: February 26, 2018
• Primary Completion: May 26, 2021
• Study Completion: May 26, 2021
• Last Updated: August 23, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)