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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 10 years
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
I have severe shoulder damage or a failed shoulder replacement with major tendon issues.
Select...
I am 18 years old or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 10 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~10 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Implant Survivorship
Secondary outcome measures
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
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
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Who is running the clinical trial?
Zimmer BiometLead Sponsor
373 Previous Clinical Trials
67,293 Total Patients Enrolled
62 Trials studying Arthritis
13,664 Patients Enrolled for Arthritis
Kacy Arnold, RN, MBAStudy DirectorZimmer Biomet
15 Previous Clinical Trials
3,900 Total Patients Enrolled
9 Trials studying Arthritis
2,213 Patients Enrolled for Arthritis
Erin OsbornStudy DirectorZimmer Biomet
11 Previous Clinical Trials
12,315 Total Patients Enrolled
3 Trials studying Arthritis
1,386 Patients Enrolled for Arthritis
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have infections that could spread to the site of a medical implant.I have been diagnosed with osteomalacia.I am physically fit for implants and my shoulder muscle works well.My X-rays show rapid joint damage or significant bone loss.I have severe shoulder damage or a failed shoulder replacement with major tendon issues.I have been diagnosed with osteoporosis.I have a condition that affects how my bones form.I am able and willing to follow study instructions.I am 18 years old or older.You currently have a problem with drinking alcohol or using drugs.
Research Study Groups:
This trial has the following groups:- Group 1: Comp. Rev. Mini Humeral Tray
- Group 2: Comp. Rev. Porous Augmented Glenoid
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many health centers are administering this trial?
"This trial has 6 sites of enrollment which include the Andrews Research and Education Foundation in Gulf Breeze, The Research Foundation for the State University of New york in Buffalo and Campbell Foundation in Germantown. Additionally, there are three other locations participating as well."
Answered by AI
Are there any recruitment slots available for this experiment?
"Data from clinicaltrials.gov lists this trial as no longer recruiting, with an initial post date of August 28th 2018 and a final update on October 17th 2022. Despite the conclusion of recruitment for this study, 503 other medical trials are currently seeking participants to fill their ranks."
Answered by AI
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