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Orthopedic Implant

Shoulder Arthroplasty for Shoulder Conditions

N/A

Recruiting

Research Sponsored by Zimmer Biomet

Eligibility Criteria Checklist

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

Must have

Patient must be 20 years of age or older

Patient must be anatomically and structurally suited to receive shoulder arthroplasty implants

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 10 years

Awards & highlights

Study Summary

This trial is testing the safety and effectiveness of the Zimmer Biomet Shoulder Arthroplasty System in people who need shoulder surgery.

Who is the study for?

This trial is for adults over 20 with shoulder issues like arthritis, fractures, or deformities who need a shoulder replacement and have a working deltoid muscle. It's not for those with neuromuscular diseases affecting the limb, severe bone conditions, infections near the joint, pregnant or breastfeeding women, vulnerable populations, or anyone unable to follow the study protocol.Check my eligibility

What is being tested?

The trial tests Zimmer Biomet Shoulder Arthroplasty Systems in patients needing new shoulders (primary) or replacements (revision). It checks if these implants are safe and work well by looking at patient scores on standard health scales, X-rays of their shoulders before and after surgery, and tracking any complications.See study design

What are the potential side effects?

Possible side effects include complications from surgery such as infection around the implant site; pain; swelling; problems with implant fit leading to discomfort or limited movement; allergic reactions to materials in the implants may also occur.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 20 years old or older.

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My body is suitable for shoulder replacement parts.

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I have severe shoulder joint issues or a failed shoulder replacement.

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My shoulder muscle works properly.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 10 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~10 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 10 years for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Frequency and Incidence of Adverse Events (Safety)

Implant Survivorship at 10 years follow-up (Kaplan Meier)

Secondary outcome measures

Clinical efficacy of the device is assessed using the American Shoulder and Elbow Surgeons (ASES) Shoulder Score at 2 years follow-up

Euroqol Patient Quality of life measured at 2 years follow-up (EQ-5D-5L)

Radiographic Performance [Glenoid Component Migration] at 2 years follow-up

+4 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: Zimmer Biomet Total Shoulder Arthroplasty SystemExperimental Treatment2 Interventions

Patients who are having primary or revision total shoulder arthroplasty who will receive a Zimmer Biomet Total Shoulder Arthroplasty System.

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Zimmer BiometLead Sponsor

373 Previous Clinical Trials

66,811 Total Patients Enrolled

3 Trials studying Shoulder Arthritis

315 Patients Enrolled for Shoulder Arthritis

Kacy Arnold, RN, MBAStudy DirectorZimmer Biomet

15 Previous Clinical Trials

3,418 Total Patients Enrolled

Ryan BoylanStudy DirectorZimmer Biomet

2 Previous Clinical Trials

371 Total Patients Enrolled

Media Library

Zimmer Biomet Shoulder Arthroplasty Systems (Orthopedic Implant) Clinical Trial Eligibility Overview. Trial Name: NCT04984291 — N/A

Shoulder Arthritis Research Study Groups: Zimmer Biomet Total Shoulder Arthroplasty System

Shoulder Arthritis Clinical Trial 2023: Zimmer Biomet Shoulder Arthroplasty Systems Highlights & Side Effects. Trial Name: NCT04984291 — N/A

Zimmer Biomet Shoulder Arthroplasty Systems (Orthopedic Implant) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04984291 — N/A

Frequently Asked Questions

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

In what locations is this clinical experiment being implemented?

"The list of locations offering this medical trial comprise Washington University in Saint Louis, William Beaumont Hospital in Royal Oak, and University of Buffalo in Buffalo, supplemented by another 7 medical sites."

Answered by AI

What is the magnitude of individuals receiving treatment through this research?

"This medical research requires 365 volunteers who are eligible according to the set criteria. Participants can join at either Washington University in Saint Louis, Missouri or William Beaumont Hospital in Royal Oak, Michigan."

Answered by AI

What are the main aims of this investigation?

"This ten-year medical research will measure the Implant Survivorship of patients over its duration. Secondary objectives include assessing Radiographic Performance, such as Humeral Component Subsidence (the gradual sinking or caving in of a device component into bone structure), Osteolysis (progressive degeneration and weakening of bones due to mineral loss) and Radiolucency Lines (darker structures that permit X-ray beams to pass through them)."

Answered by AI

Are there any current opportunities to participate in this clinical investigation?

"Yes, clinicaltrials.gov affirms that this research is actively enrolling participants. This trial was inaugurated on July 28th 2021 and had its latest edit made on October 11th 2022. To reach the required sample size of 365 individuals, recruitment will take place in 7 separate sites."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Zimmer Biomet Shoulder Arthroplasty PMCF

2021. "Zimmer Biomet Shoulder Arthroplasty PMCF". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04984291.