Stemless Reverse Shoulder Replacement for Joint Surgery

Recruiting at 16 trial locations

Overseen By Study Contact

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: DePuy Orthopaedics

Must not be taking: Chemotherapy, Corticosteroids

Disqualifiers: BMI > 40, Infections, Osteoporosis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 6

Duration: 2 years

168 Participants Needed

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. ^{1 2 3 4 5}

Why 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. ^{2 4 5 6 7}

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

I am at least 22 years old.

I can attend all required follow-up visits for the study.

I am willing and able to fill out questionnaires as required by the study.

Exclusion Criteria

Individuals that have participated in a clinical investigation with an investigational product (drug or device) in the last three months

Patients who are known to be pregnant or breastfeeding

Known polyethylene and/or metal sensitivity or allergy

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the INHANCE Stemless Reverse Total Shoulder or INHANCE Stemmed Reverse Total Shoulder

2 years

Regular follow-ups at 3 months, 6 months, 1 year, and 2 years

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments of radiolucent lines, migration, tilt, and functional scores

2 years

Follow-up visits at 3 months, 6 months, 1 year, and 2 years

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?

Group I: INHANCE Stemless Reverse Experimental Treatment 1 Intervention

INHANCE(TM) Stemless Reverse Total Shoulder

Group II: INHANCE Stemmed Reverse Active Control 1 Intervention

INHANCE(TM) Stemmed Reverse Total Shoulder

Who Is Running the Clinical Trial?

DePuy Orthopaedics

Lead Sponsor

Trials

81

Recruited

26,000+

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-ide

INHANCE Stemless Reverse Shoulder IDE 2:1 Randomized, Controlled, Multi-Center, Prospective, Pre-Market Study of the INHANCE Stemless Reverse Cementless Total Shoulder.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12546121/

Stemless vs. stemmed reverse total shoulder arthroplasty ... Conclusions. Stemless RTSA offers comparable safety and may improve functional outcomes and satisfaction in selected elderly patients, ...

3. withpower.com withpower.com/trial/phase-shoulder-8-2024-a2404

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 ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S2666639125001427

Stemless shoulder arthroplasty: what are the benefits? Stemless implants exhibit biomechanical advantages, adaptability to patient anatomy, bone preservation, simplified surgical techniques, and less invasive ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11288362/

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.,.

6. trialx.com trialx.com/clinical-trials/listings/297154/inhance-stemless-reverse-shoulder-ide/

INHANCE Stemless Reverse Shoulder IDE The study will be successful if the primary effectiveness endpoint non-inferiority analysis is successfully demonstrated, and no significant ...

7. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf21/K212737.pdf

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.