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Clinical Trials/NCT03469817
NCT03469817CompletedNot Applicable

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

Hospital for Special Surgery, New York1 site in 1 country20 target enrollmentStarted: February 26, 2018Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
20
Locations
1
Primary Endpoint
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.

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.

Study Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Parallel
Primary Purpose
Other
Masking
None

Eligibility Criteria

Ages
18 Years to 80 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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.

Arms & Interventions

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.

Intervention: MRI (Diagnostic Test)

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.

Outcomes

Primary Outcomes

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

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Hospital for Special Surgery, New York
Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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