NCT06696313

Radiographic Migration Analysis of the Insignia Hip Stem

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 25 (estimated)
• Sponsor: Canadian Radiostereometric Analysis Network · Academic / Other
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is a single-centre, non-randomized, non-controlled trial of patients undergoing primary total hip arthroplasty using the Insignia hip stem. Patients will undergo RSA and CT-RSA imaging and analyses to identify migration of the femoral stem with respect to the adjuvant bone during the first 2 post-operative years. The primary outcome of this study is to determine if femoral stem stability is achieved between 6-12 month and 12-24 month post-operative intervals.

Conditions

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

Interventions

Type	Name	Description
DEVICE	Insignia	* Insignia hip stem * Trident hemispherical shell * X3 polyethylene liner * Metal or ceramic head

Timeline

• Start date: 2025-01-15
• Primary completion: 2027-04-01
• Completion: 2027-12-01
• First posted: 2024-11-20
• Last updated: 2025-12-10

Locations

1 site across 1 country: Canada

Regulatory

• FDA-regulated device study