Active — Not RecruitingNot Applicable

Radiographic Migration Analysis of the Insignia Hip Stem

Canada25 participantsStarted 2025-01-15

Plain-language 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.

Who can participate

Age range21 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Migration

Timeframe: Up to 2 years post-operative

Trial details

NCT IDNCT06696313

SponsorCanadian Radiostereometric Analysis Network

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-04

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