A Multi-Centre Study in Patients Undergoing Total Hip Arthroplasty With the Smith+Nephew CATALYSTEM™ Primary Hip System
NCT Number: NCT06564636
Acronym: CATALYSTEM
Status: NOT_YET_RECRUITING
Study Type: OBSERVATIONAL
Conditions: Total Hip Arthroplasty (THA)|Osteoarthritis|Degenerative Joint Disease|Inflammatory Arthritis|Avascular Necrosis|Post-traumatic Arthritis|Congenital Hip Dysplasia
Interventions: DEVICE: CATALYSTEM
Sponsor: Smith & Nephew, Inc.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 198
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-08
Completion Date: 2030-02
Locations: University of California at San Francisco, San Francisco, California, 94158, United States|Connecticut Orthopaedic Institute, Hamden, Connecticut, 06518, United States|NYU Langone Health Orthopedic Hospital, New York, New York, 10003, United States|Hospital for Special Surgery, New York, New York, 10021, United States|Columbia University Medical Center, New York, New York, 10032, United States|Duke Health, Morrisville, North Carolina, 27560, United States|University of Alberta, Edmonton, Alberta, T6G 2B7, Canada|University of British Columbia, Vancouver, British Columbia, V5Z 1M9, Canada|Concordia General Hospital, Winnipeg, Manitoba, R2K 2M9, Canada|London Health Sciences Centre (LHSC), London, Ontario, N6A 5A5, Canada

Summary:
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.

Primary Outcome Measures: 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, 2 years post-operative
Secondary Outcome Measures: CATALYSTEM™ femoral stem implant survivorship rates by stem type (collard/collarless), Implant survivorship is defined as no aseptic stem revision, 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., 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., 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., Pre-operative, 6 weeks, 1 year, 2 years, and 5 years post-operative|Pain Visual Analog Scale (VAS), The Pain VAS is a pain rating scale based on self-reported measures of symptoms that are recorded with a single handwritten mark place at one point along the length of a 10 centimeter (CM) line that represents a continuum between the two ends of the scale - "no pain" on the left end (0 CM) and "worst pain" on the right end of the scale (10 CM), Preoperative, 6-weeks, 1-year, 2-years and 5 years post-operative|Radiographic findings: Femoral Stem Subsidence, The distal movement of the femoral stem into the native bone stock is recorded as Femoral Stem Subsidence. The distance between the anatomic and device landmark perpendicular to the femoral stem axis is measured. Femoral Stem Subsidence will be graded in accordance with the following definitions:

* Absent: No evidence of inferior movement of the femoral stem ≥ 3 mm.
* Present: Presence of inferior movement of the femoral stem compared to previous available imaging ≥ 3 mm., Pre-operative, 6 weeks, 1 year, 2 years, and 5 years post-operative|Radiographic Findings - Loosening, Typical aseptic loosening features would include: progressively increasing lucent lines (increase in number of zones or widening), lucencies \>2 mm extending \>50% of the implant-bone surface, stem toggle and/or component migration, device breakage or bone fractures. Typical septic loosening features include endosteal scalloping, multilamellar periosteal new bone formation, or focal lysis of bone. Femoral Component Loosening will be graded in accordance with the following definitions:

Absent: No evidence of femoral component loosening Present: Presence of femoral component loosening., Pre-operative, 6 weeks, 1 year, 2 years, and 5 years post-operative|Radiographic Findings - Femoral Stem Osteolysis, Femoral Component Osteolysis includes measurements from the AP (Anterior-Posterior) angle and the Lat (Lateral) angle in predefined zones. Femoral Osteolysis will be graded in accordance with the following definitions:

* None: No evidence of a progressive, perifemoral, bony destructive lesion with a maximum dimension \> 5 mm
* Present: Presence of a progressive, perifemoral, bony destructive lesion with a maximum dimension \> 5 mm., Pre-operative, 6 weeks, 1 Year, 2 years and 5 years post-operative|Radiographic Findings - Osseointegration Status of Femoral Stem, Femoral Component Osseointegration Status will be derived from Total Fixation Score in accordance with the following definitions:

* Absent: Total Fixation Score is -7.5
* Suspected Absent: Total Fixation Score is -5 or -2.5.
* Suspected Present: Total Fixation Score is 0, 2.5 or 5.
* Present: Total Fixation Score is 10., Pre-operative, 6 weeks, 1 year, 2 years, and 5 years post-operative|Radiographic Findings - Progressive Radiolucency, Measurements from the AP (Anterior-Posterior) angle and the Lat (Lateral) angle in in accordance with the following definitions:

* None: No evidence of an increase in width of the radiolucency \>1 mm or increase in number of zones involved in the femoral component.
* Present: Presence of an increase in width of the radiolucency \>1 mm and / or increase in the number of zones involved in the femoral component., Pre-operative, 6 weeks, 1 year, 2 years and 5 years post-operative