The primary objective is to establish the mean superior cup migration of the PINNACLE® Dual Mobility Construct using model-based RSA over the first two years post-implantation. The primary endpoint is the mean vertical subsidence (Y translation, also known as superior cup migration) at 2 years as measured with RSA. Additionally, the data from this study will be compared to historical PINNACLE® data obtained in study DSJ\_2018\_02.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
11
Pinnacle acetabular shells used with PINNACLE DM Metal liner and BIMENTUM ALTRX PE liner with DePuy metal or ceramic heads and DePuy femoral prostheses
Pinnacle acetabular shells used with Pinnacle DM Metal liner and BIMENTUM ALTRX PE liner with DePuy metal or ceramic heads and DePuy femoral prostheses
Concordia Joint Replacement Group, Concordia Hip and Knee Institute & University of Manitoba
Winnipeg, Manitoba, Canada
QEII Health Sciences Centre & Dalhousie University
Halifax, Nova Scotia, Canada
London Health Sciences Centre
London, Ontario, Canada
Superior Cup Migration
Radiostereometric analysis (RSA) measured mean superior cup migration (Y translation in MM)
Time frame: 2 years
Harris Hip Score
The Harris Hip Score (HHS) has 10 items with four subscales comprising a minimum of 0 points and a maximum of 100 points with higher scores representing better function and outcomes. The four subscales include: pain severity, activities of daily living, absence of deformity and range of motion. Scoring is done according to the following: 90-100 = excellent, 80-89 = good, 70-79 = fair, 60-69 = poor, and below 60 is a failed result
Time frame: 6 weeks post operative
HOOS Jr Score
Hip Disability and Osteoarthritis Outcome Score, Joint Replacement (HOOS, JR) assesses patient pain (2 items), and functions of daily living (4 items). Scores range from 0 to 100 with a score of 0 indicating total hip disability and 100 indicating perfect hip health. This is a patient reported joint-specific score designed to evaluate outcomes after total hip arthroplasty
Time frame: 6 weeks
FJS-12
The Forgotten Joint Score (FJS-12) is a patient-reported outcome measure intended to determine a patient's ability to "forget" about their affected joint after surgery or treatment. The Forgotten Joint Score consists of 12 questions and is scored on a 0-100 scale. The higher the score, the less the patient is aware of their affected joint when performing daily activities which suggests a better outcome
Time frame: 6 weeks
Linear Head Penetration
Femoral head penetration into the polyethylene liner component will be determined and measured radiographically
Time frame: 6 weeks, 1 year, 2 years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
RSA Measured Subsidence (Superior Cup Migration)
Superior migration of the acetabular cup will be measured using RSA
Time frame: 3 months, 6 months and 1 year
Additional RSA Measurements
Additional RSA measurements (X and Z translations in mm, X, Y, and Z rotations in degrees, and maximal total point motion in mm) at all time points
Time frame: 6 weeks, 3 months, 6 months, 1 year and 2 years