Prospective Catalystem CT-RSA

Multi-center, Non-controlled, Prospective CT-based Radiostereometric Analysis of Catalystem Primary Hip System

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Hip Osteoarthritis
• Intervention / Treatment: Device: CATALYSTEM

Detailed Description

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
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sarah Tran; Phone Number: 204-926-1231; Email: stran@orthoinno.com
• Study Contact Backup: Name: Shalini Hari Kumar; Phone Number: 204-926-1232; Email: skumar@orthoinno.com

Study Locations

• Canada
  • Manitoba
    • Winnipeg, Manitoba, Canada, R2K 2M9
      • Orthopaedic Innovation Centre
      • Principal Investigator: Thomas Turgeon, MD
      • Sub-Investigator: Eric Bohm, MD
      • Sub-Investigator: Colin Burnell, MD
      • Contact: Sarah Tran; Phone Number: 204-926-1231; Email: stran@orthoinno.com
      • Sub-Investigator: Pakpoom Ruangsomboon, MD
      • Sub-Investigator: Bryan Flynn, MD
      • Sub-Investigator: Christopher Graham, MD
      • Sub-Investigator: Elias Saidy, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. Patient requires primary unilateral THA for a severely painful and/or disabled joint from osteoarthritis, traumatic arthritis, rheumatoid arthritis, avascular necrosis, or congenital dysplasia.
2. Patients is at least 21 years old at the time of informed consent.
3. Patient is able to read and comprehend the informed patient consent document and willing and able to provide informed patient consent for participation in the study and have authorized the transfer of his/her information for study purposes.
4. Patient is able and willing to return for follow-up as specified by the study protocol.
5. Patient is able and willing to complete the required questionnaires and patient-completed portions of the study protocol.

Exclusion Criteria:

1. Patient requires implants other than the planned components or would not be a candidate for allowable components to be used (see 4) in the judgement of the surgeon.
2. Patient is planned to have simultaneous bilateral hip arthroplasty
3. Patient had contralateral hip arthroplasty less than 6 months prior to the day of surgery.
4. Patient is expected to have contralateral hip arthroplasty in the following 6 months at the time of consent into this study.
5. Patient has active local or systemic infection.
6. Patient has amputations in either leg that would impact rehabilitation following surgery.
7. Patient has loss of musculature, neuromuscular compromise or vascular compromise that would impact rehabilitation following surgery.
8. Patient has poor bone quality, such as osteoporosis, where in the surgeon's opinion, there could be considerable migration of the prosthesis, or require additional fixation, or a significant chance of periprosthetic fracture, or the lack of adequate bone to support the implant(s).
9. Patient has Charcot's or Paget's disease.
10. Patient is pregnant or lactating.
11. Patient is bedridden.
12. Patient has participated in a clinical investigation with an investigational product (drug or device) in the last 3 months.
13. Patient is currently involved in any personal injury litigation, medical-legal or worker's compensation claims.
14. Patients is, in the opinion of the surgeon, a drug or alcohol abuser or has psychological disorder(s) that could affect their ability to complete patient-reported questionnaires or be compliant with follow-up requirements.
15. Patient is diagnosed and taking prescription medications to treat a muscular disorder that limits mobility due to severe stiffness and pain such as fibromyalgia or polymyalgia.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: CATALYSTEM; CATALYSTEM Hip Replacement System	Device: CATALYSTEM; CATALYSTEM Cementless Primary Hip System for participants with Total Hip Arthroplasty

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	2 Years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	6 Weeks, 6 Months, 1 Year and 2 Years
European Quality of Life (EQ-5D-5L)	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".	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)	Pre-operative (baseline), 6 Weeks, 6 Months, 1 Year and 2 Years
Complication	Evaluate the type and frequency of the complications/adverse events.	Pre-operative (baseline), 6 Weeks, 6 Months, 1 Year and 2 Years

Collaborators and Investigators

• Sponsor: Canadian Radiostereometric Analysis Network
• Investigators: Principal Investigator: Thomas Turgeon, MD, University of Manitoba

Study record dates

Study Major Dates

• Study Start (Estimated): August 1, 2026
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028

Study Registration Dates

• First Submitted: July 7, 2026
• First Submitted That Met QC Criteria: July 7, 2026
• First Posted (Actual): July 13, 2026

Study Record Updates

• Last Update Posted (Actual): July 13, 2026
• Last Update Submitted That Met QC Criteria: July 7, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: Hip Replacement; CT-RSA; CATALYSTEM
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Arthritis; Joint Diseases; Rheumatic Diseases; Osteoarthritis; Osteoarthritis, Hip
• Other Study ID Numbers: #5179

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes