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A Prospective RSA and Clinical Evaluation of the Trident II Acetabular Cup

NCT03261986 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2020-03-17

No results posted yet for this study

Summary

The objective of this study is to use radiostereometric analysis (RSA) and clinical outcome measures to evaluate early post-operative implant stability and the clinical performance of Stryker's Trident II Acetabular Cup.

Conditions

  • Total Hip Arthroplasty
  • Acetabular Cup

Interventions

RADIATION

Radiostereometric Analysis

RSA exams of the operative hip are received post-op day 1, and at 6 weeks, 3 months, 6 months, 1 year and 2 years following surgery

PROCEDURE

total hip arthroplasty with RSA bead implantation

Patients receive RSA beads inserted into the bone surrounding the Trident II implant.

Sponsors & Collaborators

  • Midwest Orthopaedics at Rush

    lead OTHER

Principal Investigators

  • Scott Sporer, MD · Midwest Orthopaedics at Rush

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-06-09
Primary Completion
2020-10-09
Completion
2022-02-09
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03261986 on ClinicalTrials.gov