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

NCT ID: NCT03469817

Last Updated: 2021-08-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-02-26

Study Completion Date

2021-05-26

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Chronic Hip Pain

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

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.

Group Type OTHER

MRI

Intervention Type DIAGNOSTIC_TEST

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

MRI

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Stryker Nordic

INDUSTRY

Sponsor Role collaborator

Hospital for Special Surgery, New York

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Hospital for Special Surgery

New York, New York, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2017-1570

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Twins MR Imaging Study
NCT06014567 ENROLLING_BY_INVITATION
Imaging Techniques in MRI
NCT01130545 RECRUITING
Testing New Method of Analyzing MR Images
NCT00630318 TERMINATED PHASE1
Precise Image for Musculoskeletal CT
NCT07317453 NOT_YET_RECRUITING