Multi-Centre Study in patients undergoing Total Hip Arthroplasty with the Smith+Nephew CATALYSTEM™ Primary Hip System. The primary objective is to establish the mean inferior stem migration (subsidence) of the CATALYSTEM™ stem using CT-RSA over the first two postoperative years.
This study is designed as a prospective, multi-center, non-controlled study of subjects implanted with the CATALYSTEM™ Primary Hip System for primary Total Hip Arthroplasty (THA). Subjects will be enrolled and followed for 2 years post-operatively. Radiostereometric analysis (RSA) is a tool to measure implant migration, originally developed in the 1970s. It is now well-established that early migration (micromotion) of implants with respect to bone is a predictor for later aseptic loosening. Traditional RSA used dual x-ray to estimate implant migration and has been standardized. CT-based methods (CT-RSA), which do not require metal reference beads have been developed since, and have been validated with equivalent results. International guidelines have since been updated to reflect this move to CT-RSA. The primary objective is to establish the mean inferior stem migration (subsidence) of the CATALYSTEM™ stem using CT-RSA over the first two postoperative years.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
CATALYSTEM Cementless Primary Hip System for participants with Total Hip Arthroplasty
Orthopaedic Innovation Centre
Winnipeg, Manitoba, Canada
Migration - CATALYSTEM Stem
CT-RSA software (V3MA, Leiden, Netherlands) will be used for the analysis of CT images based on extracted 3-dimensional computer models of the Catalystem stem and surrounding bone from the images to represent the respective rigid bodies.
Time frame: 2 Years
Subsidence - CATALYSTEM Stem
RSA measured subsidence of the CATALYSTEM stem at 6 months and 1 year and to compared to literature values of other stems, using t-test where appropriate.
Time frame: 6 months and 1 Year
Other RSA measurements - CATALYSTEM 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 literature values of other stems, using t-test where appropriate.
Time frame: 6 Weeks, 6 Months, 1 Year and 2 Years
Oxford Hip Score
The Oxford Hip Score (OHS) is a patient self-administered 12-item questionnaire with each question having a Likaert-like response option. Each item is scored from 0 to 4, and the items are summated, with lower total scores indicating poorer performance. The OHS measures pain and general activities of daily living.
Time frame: Pre-operative (baseline), 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.
Time frame: 6 Weeks, 6 Months, 1 Year and 2 Years
European Quality of Life (EQ-5D-5L)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
EQ5D consists of 5 subscales; Mobility, Self-care, Usual activities, Pain/Discomfort and Anxiety / depression. A health state score is obtained based on the responses from 1-5 in each subscale, from which a single index value is calculated representing patients' overall health state. EQ5D includes a so called EQ VAS score which is the patients' self-rated health on a 20 cm vertical, visual analogue scale with endpoints labelled "the best health you can imagine" and "the worst health you can imagine".
Time frame: Pre-operative (baseline), 6 Weeks, 6 Months, 1 Year and 2 Years
Patient Satisfaction (VAS)
Evaluate and compare the change from preoperative to 2 years between the timepoints in patient-reported Satisfaction as measured using the visual analogue scale (VAS) from 0 (Unsatisfied) - 100 (Completely satisfied)
Time frame: Pre-operative (baseline), 6 Weeks, 6 Months, 1 Year and 2 Years
Complication
Evaluate the type and frequency of the complications/adverse events.
Time frame: Pre-operative (baseline), 6 Weeks, 6 Months, 1 Year and 2 Years