CATALYSTEM™ for Total Hip Replacement
(CATALYSTEM Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial evaluates the safety and effectiveness of the Smith+Nephew CATALYSTEM™ Primary Hip System for individuals requiring a total hip replacement. The goal is to confirm the device's performance and safety for global approval. Those with severe joint issues, such as osteoarthritis or avascular necrosis, who have had or need a hip replacement with this system, may qualify for the trial. As a Phase 3 trial, it represents the final step before FDA approval, providing an opportunity to contribute to the availability of a potentially groundbreaking treatment.
Do I need to stop my current medications for the trial?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinator or your doctor.
What prior data suggests that the CATALYSTEM™ Primary Hip System is safe for total hip arthroplasty?
Research shows that the CATALYSTEM™ Primary Hip System is designed to perform well for patients needing a hip replacement. Although specific safety data for the CATALYSTEM™ system is not available, its testing in trials for approval highlights a strong focus on safety.
Typically, when a treatment or device enters a trial, especially for approval, it has already undergone testing to ensure general safety. If the CATALYSTEM™ system has been approved for other uses, this suggests reasonable safety, even without specific side effect information here.
In summary, while detailed safety data is lacking, the trial's goal of gaining approval indicates confidence in its safety. Participants can expect that the trial is part of a careful process to ensure the device is safe and effective for hip replacements.12345Why are researchers excited about this trial?
The CATALYSTEM™ Primary Hip System is unique because it offers a cementless approach to total hip arthroplasty, which can potentially lead to faster recovery and less risk of complications compared to traditional cemented hip replacements. Researchers are excited about this system because it uses advanced technology designed to enhance the long-term stability and integration of the implant with the bone. This could mean a more durable solution for patients needing hip replacements, improving their mobility and quality of life.
What evidence suggests that the CATALYSTEM™ Primary Hip System is effective for total hip arthroplasty?
Research has shown that the CATALYSTEM Primary Hip System, which participants in this trial may receive, could benefit those needing a total hip replacement. Studies have found that this system, particularly its femoral stem, is safe and effective shortly after surgery, with few complications. The technology aims to enhance implant placement, making the surgery more predictable and reliable. Early results suggest that patients experience good outcomes, supporting the system's potential effectiveness.12346
Who Is on the Research Team?
Rachel Jahnke
Principal Investigator
Smith & Nephew, Inc.
Are You a Good Fit for This Trial?
Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Pre-operative Assessment
Participants undergo pre-operative assessments including health evaluations and baseline measurements
Surgery and Initial Recovery
Participants receive the CATALYSTEM™ Primary Hip System and begin initial recovery
Post-operative Follow-up
Participants are monitored for safety and effectiveness of the hip system
What Are the Treatments Tested in This Trial?
Interventions
- CATALYSTEM
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Participants who have already received or are due to receive the CATALYSTEM Cementless Primary Hip System
Find a Clinic Near You
Who Is Running the Clinical Trial?
Smith & Nephew, Inc.
Lead Sponsor
Dr. Maria Berkman
Smith & Nephew, Inc.
Chief Medical Officer since 2023
MD from Harvard Medical School
Dr. Deepak Nath
Smith & Nephew, Inc.
Chief Executive Officer since 2022
PhD in Theoretical Mechanics, University of California, Berkeley
Citations
CATALYSTEM◊ Primary Hip System for total hip arthroplasty
The CATALYSTEM Primary Hip System optimizes performance with patent-pending ACCUBROACH Technology, giving you the confidence of reproducible 1 implant seating.
NCT06564636 | A Multi-Centre Study in Patients ...
This study is a multi-center, prospective, non-randomized study of subjects implanted with the CATALYSTEM™ Primary Hip System for primary Total Hip Arthroplasty ...
3.
theglobeandmail.com
theglobeandmail.com/investing/markets/markets-news/Tipranks/35743615/smith-nephews-catalystem-study-a-potential-game-changer-in-hip-arthroplasty/Smith & Nephew's CATALYSTEM™ Study: A Potential ...
' The study aims to evaluate the safety and performance of the CATALYSTEM™ Primary Hip System, a device designed for patients undergoing total ...
Early Outcomes Following Total Hip Arthroplasty With a ...
The recently introduced femoral stem appears to be a safe and effective implant option in the short-term postoperative period, resulting in low complication ...
5.
ctv.veeva.com
ctv.veeva.com/study/a-multi-centre-study-in-patients-undergoing-total-hip-arthroplasty-with-the-smith-nephew-catalystemA Multi-Centre Study in Patients Undergoing Total Hip ...
Subject has undergone primary THA with the S+N CATALYSTEM™ Primary Hip stem in the past 12 months for end stage degenerative joint disease (primary diagnosis of ...
Multi-Centre Study in Patients Undergoing Total Hip ...
The purpose of the study is to assess safety and performance of the CATALYSTEM™ and to support product approval in global markets. Details. This study is a ...
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