Stemless Reverse Shoulder Replacement for Joint Surgery
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests two types of shoulder replacements for individuals with painful, arthritic shoulder joints. The goal is to compare the effectiveness of a stemless implant (INHANCE Stemless Reverse Cementless Total Shoulder) with a traditional stemmed implant. Participants must have severe shoulder pain due to arthritis or a similar condition and be suitable for shoulder surgery. The trial aims to enhance shoulder replacement options and outcomes. As an unphased trial, it offers participants the chance to contribute to advancements in shoulder replacement technology and improve future treatment options.
Do I need to stop my current medications to join the trial?
The trial information does not specify if you need to stop taking your current medications. However, if you are receiving treatments that could affect bone quality, like chemotherapy or high-dose corticosteroids, you may not be eligible to participate.
What prior data suggests that the INHANCE Stemless Reverse Cementless Total Shoulder is safe?
Research has shown that the INHANCE Stemless Reverse Cementless Total Shoulder replacement is designed for safety. Studies have found that this shoulder implant can be as safe as the traditional version with a stem. It may also improve movement and satisfaction for older patients.
The stemless design preserves more natural bone, potentially making surgery quicker and easier to revise if necessary. Studies have not reported any major safety issues, suggesting it is generally well-tolerated. However, as with any surgery, risks may exist, and potential side effects should be discussed with a healthcare provider.12345Why are researchers excited about this trial?
Researchers are excited about the INHANCE Stemless Reverse Total Shoulder treatment because it offers a new approach to shoulder replacement surgery. Unlike traditional shoulder replacements that often involve a long stem inserted into the arm bone, this treatment is stemless and cementless, which can potentially lead to less invasive surgery and quicker recovery times. The stemless design helps preserve more of the patient’s natural bone, which is a significant advantage over the conventional stemmed options. Additionally, this innovative design might reduce the risk of complications associated with stemmed implants, such as bone fractures or implant loosening over time.
What evidence suggests that this trial's treatments could be effective for joint surgery?
Research has shown that stemless reverse total shoulder replacements can be as safe as traditional methods. They may also enhance shoulder function and boost patient satisfaction after surgery, particularly in older adults. In this trial, participants may receive the INHANCE Stemless Reverse Cementless Total Shoulder, designed to preserve more bone and expedite the surgery. This implant is also easier to adjust or replace if needed later. It fits well with the patient's natural shoulder shape and involves a less invasive procedure, potentially leading to a faster recovery.24567
Are You a Good Fit for This Trial?
This trial is for adults over 22 with severe shoulder arthritis or similar conditions, who need a reverse total shoulder replacement and can follow the study's visits and questionnaires. Excluded are those with recent participation in other trials, pregnancy, metal allergies, high BMI, short life expectancy due to medical conditions, ongoing legal claims related to injury or compensation, substance abuse issues, certain psychological disorders that could affect compliance with the study requirements.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive the INHANCE Stemless Reverse Total Shoulder or INHANCE Stemmed Reverse Total Shoulder
Follow-up
Participants are monitored for safety and effectiveness after treatment, including assessments of radiolucent lines, migration, tilt, and functional scores
What Are the Treatments Tested in This Trial?
Interventions
- INHANCE Stemless Reverse Cementless Total Shoulder
Trial Overview
The INHANCE Stemless Reverse Shoulder trial tests a new type of shoulder joint replacement without using a stem in the bone. Participants will be randomly assigned at a ratio of 2:1 to either receive this new implant or not as part of their surgery. The outcomes will be compared between groups.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
INHANCE(TM) Stemless Reverse Total Shoulder
INHANCE(TM) Stemmed Reverse Total Shoulder
Find a Clinic Near You
Who Is Running the Clinical Trial?
DePuy Orthopaedics
Lead Sponsor
Massimo Calafiore
DePuy Orthopaedics
Chief Executive Officer since 2023
MBA from Harvard Business School
Dr. Michael Stein
DePuy Orthopaedics
Chief Medical Officer since 2023
MD from University of Michigan
Citations
1.
centerwatch.com
centerwatch.com/clinical-trials/listings/NCT06323980/inhance-stemless-reverse-shoulder-ideINHANCE Stemless Reverse Shoulder IDE
2:1 Randomized, Controlled, Multi-Center, Prospective, Pre-Market Study of the INHANCE Stemless Reverse Cementless Total Shoulder.
Stemless vs. stemmed reverse total shoulder arthroplasty ...
Conclusions. Stemless RTSA offers comparable safety and may improve functional outcomes and satisfaction in selected elderly patients, ...
Stemless Reverse Shoulder Replacement for Joint Surgery
The INHANCE Stemless Reverse Cementless Total Shoulder treatment is unique because it preserves more bone, reduces surgical time, and allows for easier revision ...
Stemless shoulder arthroplasty: what are the benefits?
Stemless implants exhibit biomechanical advantages, adaptability to patient anatomy, bone preservation, simplified surgical techniques, and less invasive ...
Recent Advances in the Design and Application of Shoulder ...
Since then, TSA has demonstrated promising clinical outcomes, radiographic stability, low complication rates, and impressive implant longevity.,.
INHANCE Stemless Reverse Shoulder IDE
The study will be successful if the primary effectiveness endpoint non-inferiority analysis is successfully demonstrated, and no significant ...
K212737.pdf - accessdata.fda.gov
The INHANCE SHOULDER SYSTEM with a humeral stem is intended for use in anatomic total, reverse total, or hemi-shoulder replacement procedures.
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