A Multi-Center Study in Patients Undergoing Total Hip Arthroplasty with the Smith+Nephew CATALYSTEM™ Primary Hip System. The purpose of the study is to assess safety and performance of the CATALYSTEM™ and to support product approval in global markets.
This study is a multi-center, prospective, non-randomized study of subjects implanted with the CATALYSTEM™ Primary Hip System for primary Total Hip Arthroplasty (THA). Subjects will be enrolled and followed for 5 years post-operatively to assess safety and efficacy of the CATALYSTEM™ Primary Hip System. The primary objective is to assess 2-year post-operative stem survivorship of the CATALYSTEM™ Hip System (i.e. the femoral stem with all its variants and instrumentation) in primary THA procedures for each stem type (Collared/Collarless). Stem survivorship is defined as no aseptic revision of the implanted femoral stem.
Study Type
OBSERVATIONAL
Enrollment
198
CATALYSTEM Cementless Primary Hip System for participants with Total Hip Arthroplasty
University of California at San Francisco
San Francisco, California, United States
Connecticut Orthopaedic Institute
Hamden, Connecticut, United States
Orlando Health Inc.
Orlando, Florida, United States
Illinois Bone and Joint Institute
Des Plaines, Illinois, United States
NYU Langone Health Orthopedic Hospital
New York, New York, United States
Duke Health
Morrisville, North Carolina, United States
University of Alberta
Edmonton, Alberta, Canada
University of British Columbia
Vancouver, British Columbia, Canada
Concordia General Hospital
Winnipeg, Manitoba, Canada
London Health Sciences Centre (LHSC)
London, Ontario, Canada
CATALYSTEM™ femoral stem implant survivorship 2 years post-operatively by stem type (collared/collarless)
Stem survivorship is defined as no aseptic revision of the implanted femoral stem
Time frame: 2 years post-operative
CATALYSTEM™ femoral stem implant survivorship rates by stem type (collard/collarless)
Implant survivorship is defined as no aseptic stem revision
Time frame: 6 weeks, 1 year, and 5 years post-operative
Hip Disability and Osteoarthritis Outcome Score, Junior (HOOS Jr)
Patient-administered self-report survey based on the HOOS that specifically focuses on the outcome after THA. HOOS, JR. consists of 2 areas: pain (2 items) and function, daily living (4 items). The last week is taken into consideration when answering the questions. Standardized answer options are given (5 Likert boxes - none, mild, moderate, severe, extreme) and each question gets a score from 0 to 4. An interval score from 0 -100 (0 indicating total hip disability and 100 indicating perfect hip health) is calculated.
Time frame: Pre-operative, 6 weeks, 1 year, 2 years, and 5 years post-operative
EuroQol 5-Dimension 5-Level Visual Analogue Scale (EQ-5D-5L VAS)
The VAS records the subject's self-rated health on a vertical visual analogue scale. The endpoints on the scale are labelled "The best health you can imagine" and "The worst health you can imagine". Participants indicate a numerical value from 1-100 where 0 is the worst imaginable health state and 100 is the best imaginable health state. The VAS can be used as a quantitative measure of health outcome as judged by the individual respondents.
Time frame: Pre-operative, 6 weeks, 1 year, 2 years, and 5 years post-operative
Quality of Life (EQ-5D-5L) Index Score
The descriptive system is used to describe the subject's health state \& consists of 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 5 levels to choose the most appropriate answer: no problems, slight problems, moderate problems, severe problems, and extreme problems. The subject is asked to indicate his/her health state by marking the most appropriate statement in each of the five areas. Responses are coded as single-digit numbers expressing the severity level selected in each dimension. For instance, 'slight problems' (e.g. 'I have slight problems in walking about') is always coded as '2'.) The digits for the 5 dimensions are combined in a 5-digit code. The EQ- 5D-5L index value is derived by using the vendor supplied calculator to convert each 5-digit EQ-5D-5L profile. A higher number is a better outcome.
Time frame: Pre-operative, 6 weeks, 1 year, 2 years, and 5 years post-operative
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.