Radiographic Migration Analysis of the Insignia Hip Stem

N/AActive Not RecruitingNCT06696313

Canadian Radiostereometric Analysis Network25 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Hip Implant Hip Replacement in Osteoarthritis Patients

Eligibility

Sex: ALLMin age: 21 Years

Medical Language ↔ Plain English

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