Radiographic Migration Analysis of the Insignia Hip Stem

Canadian Radiostereometric Analysis Network

Status: Active, not recruiting

Conditions: Migration of Implant; Hip Implant; Hip Replacement in Osteoarthritis Patients

Treatments: Device: Insignia

Study type: Interventional

Funder types: Other

Identifiers

NCT06696313

B2024:118

Details and patient eligibility

About

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.

Full 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.

Enrollment: 25 estimated patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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25 participants in 1 patient group

Insignia

Other group

Description:

Total hip replacement CT-RSA vs gold standard RSA

Treatment:

Device: Insignia