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Radiographic Migration Analysis of the Insignia Hip Stem

NCT06696313 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2025-12-10

No results posted yet for this study

Summary

The purpose of this study is to assess the migration pattern of the Insignia hip stem using radiostereometric analysis (RSA for short) and computed tomography (CT). Only patients with degenerative joint disease requiring primary total hip replacement will be asked to participate. The other purpose is to assess if there are any differences between the gold-standard RSA-measured migration and CT-RSA-measured migration. The clinical outcomes will be measured using joint function and patient satisfaction questionnaires. Approximately thirty patients will be enrolled onto the study.

Conditions

  • Hip Implant
  • Hip Replacement in Osteoarthritis Patients
  • Migration of Implant

Interventions

DEVICE

Insignia

* Insignia hip stem * Trident hemispherical shell * X3 polyethylene liner * Metal or ceramic head

Sponsors & Collaborators

  • Orthopaedic Innovation Centre

    collaborator OTHER

  • Canadian Radiostereometric Analysis Network

    lead OTHER

Principal Investigators

  • Eric R Bohm, MD · Orthopaedic Innovation Centre

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-01-15
Primary Completion
2027-04-30
Completion
2027-12-31
FDA Device
Yes

Countries

  • Canada

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 NCT06696313 on ClinicalTrials.gov