Radiographic Migration Analysis of the Insignia Hip Stem

NCT06696313 | Active Not Recruiting FDA Device

• 1 other identifier: B2024:118
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Insignia; RSA; Total hip replacement

Outcome Measures

Primary Outcomes (1)

• Migration

  Quantify migration of the Insignia stem using RSA and CT-RSA

  Up to 2 years post-operative

Secondary Outcomes (5)

• Validation

  Up to 2 years post-operative

• Early migration

  Up to 2 years post-operative

• Changes in Oxford-12 Hip Score from baseline(pre-op) to 6-month, 1-year and 2-year

  Up to 2 years post-operative

• Changes in EQ-5D-5L from baseline(pre-op) to 6-month, 1-year and 2-year

  Up to 2 years post-operative

• Changes in Patient Satisfaction (VAS) from baseline(pre-op) to 6-month, 1-year and 2-year

  Up to 2 years post-operative

Study Arms (1)

Insignia

OTHER

Total hip replacement CT-RSA vs gold standard RSA

Device: Insignia

Interventions

Insignia DEVICE

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

Insignia

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Symptomatic osteoarthritis of the hip indicating primary total hip arthroplasty - Aged 21 years or older
• Patients willing and able to comply with follow-up requirements and self-evaluations
• Ability to give informed consent

You may not qualify if:

• Active or prior infection
• Medical condition precluding major surgery
• Medical condition with less than 2 years life expectancy
• Overhanging pannus (direct anterior approach)
• Prior surgery of the hip involving implantation of hardware (i.e., hemiarthroplasty, internal fixation, pelvic reconstruction near the acetabulum requiring removal)
• Skin condition on the area of incision
• Multi-level lumbar spine fusion
• Ankylosing spondylolithesis
• Shortening osteotomy through the femur

Sponsors & Collaborators

• Canadian Radiostereometric Analysis Network: lead
• Orthopaedic Innovation Centre: collaborator

Study Sites (1)

Concordia Hip & Knee Institute

Winnipeg, Manitoba, R2K 2M9, Canada

Location

Study Officials

• Eric R Bohm, MD

  Orthopaedic Innovation Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 14, 2024
• First Posted: November 20, 2024
• Study Start: January 15, 2025
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: December 10, 2025

Record last verified: 2025-12

Locations

CA (1)