Radiographic Migration Analysis of the Insignia Hip Stem

NCT ID: NCT06696313

Last Updated: 2025-12-10

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-01-15
• Study Completion Date: 2027-12-31

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.

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Insignia

Total hip replacement CT-RSA vs gold standard RSA

Group Type: OTHER

Insignia

Intervention Type: DEVICE

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

Interventions

Insignia

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

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 21 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Canadian Radiostereometric Analysis Network

OTHER

Sponsor Role: lead

Orthopaedic Innovation Centre

OTHER

Sponsor Role: collaborator

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Eric R Bohm, MD

Role: PRINCIPAL_INVESTIGATOR

Orthopaedic Innovation Centre

Locations

Concordia Hip & Knee Institute

Winnipeg, Manitoba, Canada

Countries

Canada

Other Identifiers

B2024:118

Identifier Type: -

Identifier Source: org_study_id