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

Trial Summary

What is the purpose of this trial?

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

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 data supports the effectiveness of the INHANCE Stemless Reverse Cementless Total Shoulder treatment?

Research shows that stemless reverse shoulder replacements, like the INHANCE treatment, can provide good clinical and radiologic outcomes, similar to other shoulder implants, with benefits such as preserving more bone. A case study also reported positive results after two years for a patient who received a stemless reverse implant. ^{1 2 3 4 5}

Is stemless reverse shoulder replacement generally safe for humans?

Stemless reverse shoulder replacement appears to be generally safe, with studies showing similar complication rates to traditional designs and fewer issues like fractures during surgery. However, there is limited data, and more long-term studies are needed to confirm these findings. ^{2 6 7 8 9}

What makes the INHANCE Stemless Reverse Cementless Total Shoulder treatment unique compared to other shoulder replacement options?

The INHANCE Stemless Reverse Cementless Total Shoulder treatment is unique because it preserves more bone, reduces surgical time, and allows for easier revision compared to traditional stemmed implants. It is particularly beneficial for patients with rotator cuff issues and is part of a growing trend towards using stemless implants for shoulder replacements. ^{2 5 10 11 12}

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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

References

1. United States pubmed.ncbi.nlm.nih.gov

Stemless reverse shoulder arthroplasty: clinical and radiologic outcomes with minimum 2 years' follow-up. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Stemless reverse total shoulder arthroplasty: a systematic review. [2022]

3. Netherlands pubmed.ncbi.nlm.nih.gov

Patient-reported outcomes of reverse total shoulder arthroplasty: a comparative risk factor analysis of improved versus unimproved cases. [2022]

4. Germany pubmed.ncbi.nlm.nih.gov

Reverse shoulder arthroplasty in revision of failed shoulder arthroplasty-outcome and follow-up. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Revision of a Stemless Anatomic Implant into a Stemless Reverse Implant. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

A multicenter, prospective 2-year analysis of the Sidus stem-free shoulder arthroplasty system. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Diagnosis and Management of Early Complications After Reverse Shoulder Arthroplasty. [2022]

8. England pubmed.ncbi.nlm.nih.gov

Results of stemless shoulder arthroplasty: a systematic review and meta-analysis. [2021]

9. United States pubmed.ncbi.nlm.nih.gov

Larger polyethylene glenospheres in reverse shoulder arthroplasty: are they safe? [2022]

10. United States pubmed.ncbi.nlm.nih.gov

Stemless reverse total shoulder arthroplasty: a systematic review of short- and mid-term results. [2022]

11. United States pubmed.ncbi.nlm.nih.gov

Clinical and radiological outcomes of a stemless reverse shoulder implant: a two-year follow-up in 56 patients. [2022]

12. Germany pubmed.ncbi.nlm.nih.gov

[Shoulder endoprosthesis in the elderly : Hemiarthroplasty or total shoulder arthroplasty? Anatomic or reverse?] [2018]