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Orthopedic Implant

Shoulder Implant for Arthritis

N/A

Waitlist Available

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 have a grossly deficient rotator cuff with severe arthropathy and/or a previously failed shoulder joint replacement with a grossly deficient rotator cuff

Patient must be 18 years of age or older

Must not have

Patient has distant foci of infections which may spread to the implant site

Patient has osteomalacia

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 10 years

Awards & highlights

No Placebo-Only Group

Summary

This trialwill test a new shoulder implant to make sure it's safe and effective for primary and revision surgeries.

Who is the study for?

This trial is for adults over 18 who need shoulder replacement due to severe arthritis or rotator cuff injuries and have a working deltoid muscle. They must be able to follow the study plan and give informed consent. It's not for those with osteoporosis, metabolic bone diseases, rapid joint destruction, current substance abuse, infection risks, or uncooperative patients.

What is being tested?

The safety and performance of two shoulder implant components—the Comprehensive Mini Humeral Tray and Porous Augmented Glenoid—are being tested in people needing new shoulders or revisions. The study observes patients at multiple centers without randomizing treatment groups.

What are the potential side effects?

While specific side effects are not listed here, common risks associated with shoulder implants may include pain, infection at the surgery site, implant wear or failure leading to additional surgeries.

Eligibility Criteria

Inclusion Criteria

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

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I have severe shoulder damage or a failed shoulder replacement with major tendon issues.

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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have infections that could spread to the site of a medical implant.

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I have been diagnosed with osteomalacia.

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My X-rays show rapid joint damage or significant bone loss.

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I have been diagnosed with osteoporosis.

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I am able and willing to follow study instructions.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Implant Survivorship

Secondary study objectives

Clinical efficacy of the device is assessed using the American Shoulder and Elbow Surgeon Score Patient Questionnaire.

Frequency and Incidence of Adverse Events

Radiographic Performance

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Comp. Rev. Porous Augmented GlenoidExperimental Treatment1 Intervention

Subjects with a grossly deficient rotator cuff in need of a reverse shoulder arthroplasty who met the inclusion/exclusion criteria and received the Comprehensive Reverse Porous Augmented Glenoid.

Group II: Comp. Rev. Mini Humeral TrayExperimental Treatment1 Intervention

Subjects with a grossly deficient rotator cuff in need of a reverse shoulder arthroplasty who met the inclusion/exclusion criteria and received the Comprehensive Reverse Mini Humeral Tray

0 / 7Eligibility criteria met