Humeral System for Shoulder Osteoarthritis
(PHS Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to gather safety and performance data on a shoulder replacement device called the Tornier Perform Humeral Stem. It focuses on individuals needing a partial or total shoulder joint replacement, often due to shoulder issues that hinder daily activities. The trial tracks participants from before surgery and continues collecting data annually for up to 10 years. It suits individuals already considering shoulder arthroplasty (joint replacement surgery) and willing to follow the study requirements. As a Phase 4 trial, this study involves an FDA-approved device, offering participants the chance to contribute to understanding its benefits for more patients.
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 coordinators or your doctor.
What is the safety track record for the Tornier Perform Humeral Stem?
Research has shown that the Tornier Perform Humeral Stem is approved for use in certain shoulder surgeries, such as total shoulder replacement, indicating it has been evaluated for safety in these procedures. Although detailed studies specifically about this device are limited, its approval suggests general safety. This study serves as a follow-up after the product's market release, indicating it is deemed safe for broader use. While this does not eliminate all risks, it suggests that the risks are not significant. Overall, current evidence supports the safety of the Tornier Perform Humeral Stem when used as intended.12345
Why are researchers enthusiastic about this study treatment?
The Tornier Perform Humeral Stem is unique because it offers a modular system specifically designed for partial or total shoulder arthroplasty. Unlike standard treatments that might use fixed or less adaptable components, this system allows for greater customization to match patient anatomy, potentially improving joint function and comfort. Researchers are excited about this treatment because its design could lead to better outcomes and shorter recovery times compared to traditional shoulder replacement options.
What evidence suggests that the Tornier Perform Humeral Stem is effective for shoulder arthroplasty?
Research has shown that the Tornier Perform Humeral Stem works well for shoulder replacements. Studies have found that it improves movement in all directions and increases patient satisfaction. After five years, shoulder replacements using the Tornier Perform Humeral Stem consistently show only 2% of cases experiencing minor issues like bone loosening. This system is used for various shoulder surgeries, including partial and total replacements. Overall, it offers reliable and long-lasting results for those needing shoulder joint replacement.23678
Who Is on the Research Team?
Rebecca Gibson
Principal Investigator
Stryker Trauma
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
Surgery
Participants undergo partial or total shoulder arthroplasty using the Tornier Perform Humeral Stem
Post-Operative Follow-up
Safety and performance data collected at baseline, immediate post-op, and annually through 10 years post-operation
What Are the Treatments Tested in This Trial?
Interventions
- Tornier Perform Humeral - Stem
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Partial or total shoulder arthroplasty using the Tornier Perform Humeral Stem.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Stryker Trauma and Extremities
Lead Sponsor
Tornier, Inc.
Lead Sponsor
Stryker Trauma GmbH
Lead Sponsor
Citations
NCT05067543 | Perform Humeral System Study
The PERFORM Humeral System - Stem is a non-constrained prosthesis intended for the total or partial replacement of the glenohumeral articulation. What is the ...
Outcomes Between Stemmed and Stemless Total Shoulder ...
Consistent functional outcomes at the 5-year follow-up with stemmed and stemless TSA, though without significant improvement from 2 to 5 years.
Current state of short-stem implants in total shoulder ...
Improvements were seen in all measured range of motion planes and patient-reported outcome scores. Complications were infrequent, with a 2% humeral loosening ...
Tornier Perform Humeral Stem
Platform humeral system intended for anatomic, reverse and hemi-arthroplasty of the shoulder. Tornier Perform Humeral Stem
Shoulder Replacement Clinical Trials
TORNIER PERFORM™ Stemless Reverse IDE Study Rochester, MN. The purpose of this study is to evaluate safety and efficacy and show non-inferiority of the ...
Tornier, Inc. September 11, 2020 Renee Stoffel Principal ...
The PERFORM Humeral System – Stem is intended to be used with cemented polyethylene glenoid components, in a total shoulder arthroplasty.
Tornier, Inc. September 14, 2022 Renee Stoffel Principal ...
No clinical studies were performed. Conclusions. The Tornier Perform® Humeral System – Stemless does not raise different questions of safety or.
Perform Humeral System Study | Clinical Research Trial ...
This study is an international, single arm, multicenter, prospective, non-significant risk, Post-Market Clinical Follow-up study. Data will be ...
Unbiased Results
We believe in providing patients with all the options.
Your Data Stays Your Data
We only share your information with the clinical trials you're trying to access.
Verified Trials Only
All of our trials are run by licensed doctors, researchers, and healthcare companies.