This study is designed as a prospective, multi-centre, non-randomized, non-controlled study. This study does not limit the procedures involved in the treatment of the subject as long as the protocol specified products are utilized. The primary objective is to establish the mean superior cup migration of the Emphasys Shell and the mean inferior stem migration of the Emphasys Stem using model-based RSA over the first two years post-implantation. Additionally, the data from this study will be compared to historical Pinnacle Acetabular Shell data obtained in study DSJ\_2018\_02.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Emphasys Acetabular Shell, Emphasys AOX Polyethylene Liner, Articul/eze 12/14 metal head and Emphasys fem. stem
Orthopaedic Innovation Centre
Winnipeg, Manitoba, Canada
RECRUITINGMigration - Shell
The mean vertical subsidence (Y translation, also known as superior shell migration) at 2 years as measured with RSA.
Time frame: 2 Years
Migration - Stem
The mean vertical subsidence (Y translation, also known as inferior stem migration) at 2 years as measured with RSA.
Time frame: 2 Years
Subsidence - Emphasys Shell
RSA measured subsidence of the Emphasys Shell at 6 months and 1 year and to compare it to historical Pinnacle Shell data
Time frame: 6 months, 1 Year
Subsidence - Emphasys Stem
RSA measured subsidence of the Emphasys Stemat 6 months and 1 year
Time frame: 6 months, 1 Year
Other RSA measurements - Emphasys Shell
Other RSA measurements of the Emphasys Shell (X and Z translations in mm, X, Y, and Z rotations in degrees, and maximal total point motion in mm) at all time points. These endpoints will be compared to historical Pinnacle Shell data.
Time frame: 6 Weeks, 6 months, 1 year and 2 years
Other RSA measurements - Emphasys Stem
Other RSA measurements of the Emphasys Stem (X and Z translations in mm, X, Y, and Z rotations in degrees, and maximal total point motion in mm) at all time points. These endpoints will be compared to historical Pinnacle Shell data.
Time frame: 6 Weeks, 6 months, 1 year and 2 years
Head Penetration (in mm)
Linear head penetration (in mm) at 1 year and 2 years. This endpoint will be compared to historical Pinnacle data.
Time frame: 1 year and 2 years
HOOS Jr.
Functional and health status will be measured with HOOS Jr. This is a patient-reported outcome measure for which scores range from 0 to 100; a score of 0 indicating total hip disability and 100 indicating optimal hip health.These endpoints will be compared to historical Pinnacle data.
Time frame: Pre-op, 6 weeks, 6 months, 1 year and 2 years
Harris Hip Score
Functional score will be measured with Harris Hip Score. The score has a maximum of 100 points (best possible outcome) covering pain (1 item, 0-44 points), function (7 items, 0-47 points), absence of deformity (1 item, 4 points), and range of motion (2 items, 5 points). These endpoints will be compared to historical Pinnacle data.
Time frame: Pre-op, 6 weeks, 6 months, 1 year and 2 years
Forgotten Joint Score (FJS-12)
Functional and health status will be measured with the Forgotten Joint Score (FJS-12). The FJS total score range is 0-100, higher scores indicating the patient is able to forget the joint daily lower degree of joint awareness. These endpoints will be compared to historical Pinnacle data.
Time frame: Pre-op, 6 weeks, 6 months, 1 year and 2 years
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