Prospective Catalystem CT-RSA

NCT07698717 | Not Yet Recruiting FDA Device

• 1 other identifier: #5179
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hip Osteoarthritis

Keywords

Hip Replacement; CATALYSTEM; CT-RSA

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Subsidence - CATALYSTEM Stem

  6 months and 1 Year

• Other RSA measurements - CATALYSTEM stem

  6 Weeks, 6 Months, 1 Year and 2 Years

• Oxford Hip Score

  Pre-operative (baseline), 6 Weeks, 6 Months, 1 Year and 2 Years

• Forgotten Joint Score (FJS-12)

  6 Weeks, 6 Months, 1 Year and 2 Years

• European Quality of Life (EQ-5D-5L)

  Pre-operative (baseline), 6 Weeks, 6 Months, 1 Year and 2 Years

Study Arms (1)

CATALYSTEM

OTHER

CATALYSTEM Hip Replacement System

Device: CATALYSTEM

Interventions

CATALYSTEM DEVICE

CATALYSTEM Cementless Primary Hip System for participants with Total Hip Arthroplasty

CATALYSTEM

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient requires primary unilateral THA for a severely painful and/or disabled joint from osteoarthritis, traumatic arthritis, rheumatoid arthritis, avascular necrosis, or congenital dysplasia.
• Patients is at least 21 years old at the time of informed consent.
• 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.
• Patient is able and willing to return for follow-up as specified by the study protocol.
• Patient is able and willing to complete the required questionnaires and patient-completed portions of the study protocol.

You may not qualify if:

• 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.
• Patient is planned to have simultaneous bilateral hip arthroplasty
• Patient had contralateral hip arthroplasty less than 6 months prior to the day of surgery.
• Patient is expected to have contralateral hip arthroplasty in the following 6 months at the time of consent into this study.
• Patient has active local or systemic infection.
• Patient has amputations in either leg that would impact rehabilitation following surgery.
• Patient has loss of musculature, neuromuscular compromise or vascular compromise that would impact rehabilitation following surgery.
• 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).
• Patient has Charcot's or Paget's disease.
• Patient is pregnant or lactating.
• Patient is bedridden.
• Patient has participated in a clinical investigation with an investigational product (drug or device) in the last 3 months.
• Patient is currently involved in any personal injury litigation, medical-legal or worker's compensation claims.
• 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.
• 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.

Sponsors & Collaborators

• Canadian Radiostereometric Analysis Network: lead

Study Sites (1)

Orthopaedic Innovation Centre

Winnipeg, Manitoba, R2K 2M9, Canada

Location

MeSH Terms

Conditions

Osteoarthritis, Hip

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Thomas Turgeon, MD

  University of Manitoba

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sarah Tran

CONTACT

204-926-1231; stran@orthoinno.com

Shalini Hari Kumar

CONTACT

204-926-1232; skumar@orthoinno.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 7, 2026
• First Posted: July 13, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: July 13, 2026

Record last verified: 2026-07

Locations

CA (1)