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Orthopedic Implant

Onlay vs Inlay Techniques for Shoulder Replacement

N/A

Recruiting

Led By Alex Martusiewicz, MD

Research Sponsored by William Beaumont Hospitals

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years postoperative

Awards & highlights

Study Summary

This trial compares different ways to place a component in the upper arm in shoulder replacement surgery to see if it affects arm function.

Who is the study for?

This trial is for adults over 18 who need a reverse total shoulder arthroplasty due to rotator cuff tears or arthritis, and can rotate their arm outward. It's not for those with previous open shoulder surgery, cognitive impairments, pregnancy, minors, or conditions like rheumatoid arthritis.Check my eligibility

What is being tested?

The study compares two surgical techniques of placing the humeral component in shoulder replacement: 'inlay' (inside the bone) versus 'onlay' (on top of the bone), using Tornier Ascend Flex stem and Perform Stem Reverse+ implants.See study design

What are the potential side effects?

Potential side effects may include limited range of motion post-surgery, pain at the site of operation, possible infection risks associated with any surgery, and complications related to implant positioning.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years postoperative

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 years postoperative

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years postoperative for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Active external rotation, 2 years

Secondary outcome measures

Abduction, 1 year

Abduction, 2 years

Abduction, 3 months

+49 more

Trial Design

2Treatment groups

Active Control

Group I: Onlay Component-Tornier Ascend Flex stemActive Control1 Intervention

Reverse Total Shoulder Arthroplasty using onlay component (tray placed at top of humerus)

Group II: Inlay Component-Tornier Perform Stem Reverse+Active Control1 Intervention

Reverse Total Shoulder Arthroplasty using inlay component (tray placed in humerus)

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

William Beaumont HospitalsLead Sponsor

149 Previous Clinical Trials

112,704 Total Patients Enrolled

Stryker NordicIndustry Sponsor

32 Previous Clinical Trials

3,941 Total Patients Enrolled

Alex Martusiewicz, MDPrincipal InvestigatorBeaumont Health

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is enrollment for this experiment still open?

"According to clinicaltrials.gov, this medical trial is looking for volunteers and has been open since October 20th of this year (2023). The post was last amended on October 26th."

Answered by AI

How many participants are being included in this clinical trial?

"Assuredly, the information present on clinicaltrials.gov shows that this trial is actively recruiting people to partake in it. First posted on October 20th of 2023 and last updated a week later, this research seeks 154 individuals from one location."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Onlay Versus Inlay Humeral Component in Reverse Total Shoulder Arthroplasty

Dr. Alex Martusiewicz 2023. "Onlay Versus Inlay Humeral Component in Reverse Total Shoulder Arthroplasty". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05297305.