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Prosthesis

Large-Diameter Glenosphere +2 mm offset for Shoulder Arthritis

N/A
Waitlist Available
Led By Mark Morrey, M.D.
Research Sponsored by Mayo Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Subjects willing to sign the informed consent
Male and non-pregnant female subjects ages 50 - 90 at the time of surgery
Timeline
Screening 3 weeks
Treatment Varies
Follow Up one year
Awards & highlights

Study Summary

This trial will compare the results of two different sizes of shoulder implants, both with different offsets.

Eligibility Criteria

Inclusion Criteria

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

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~one year
This trial's timeline: 3 weeks for screening, Varies for treatment, and one year 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 of the Shoulder
Active Forward Elevation of the Shoulder
Shoulder Abduction Strength
+2 more
Secondary outcome measures
American Shoulder and Elbow Surgeons (ASES) Questionnaire
Oxford Shoulder Score (OSS) Questionnaire
Patient Satisfaction
+2 more

Trial Design

4Treatment groups
Active Control
Group I: Large-Diameter Glenosphere +2 mm offsetActive Control1 Intervention
Primary Reverse Shoulder Arthroplasty using the ReUnion System with a Large-Diameter Glenosphere +2 mm offset
Group II: Small-Diameter Glenosphere +2 mm offsetActive Control1 Intervention
Primary Reverse Shoulder Arthroplasty using the ReUnion System with a Small-Diameter Glenosphere +2 mm offset
Group III: Large-Diameter Glenosphere +6 mm offsetActive Control1 Intervention
Primary Reverse Shoulder Arthroplasty using the ReUnion System with a Large-Diameter Glenosphere +6 mm offset
Group IV: Small-Diameter Glenosphere +6 mm offsetActive Control1 Intervention
Primary Reverse Shoulder Arthroplasty using the ReUnion System with a Small-Diameter Glenosphere +6 mm offset

Find a Location

Who is running the clinical trial?

Mayo ClinicLead Sponsor
3,175 Previous Clinical Trials
3,757,998 Total Patients Enrolled
1 Trials studying Shoulder Arthritis
4 Patients Enrolled for Shoulder Arthritis
Stryker NordicIndustry Sponsor
32 Previous Clinical Trials
4,020 Total Patients Enrolled
1 Trials studying Shoulder Arthritis
154 Patients Enrolled for Shoulder Arthritis
Mark Morrey, M.D.Principal InvestigatorMayo Clinic
1 Previous Clinical Trials
4 Total Patients Enrolled
1 Trials studying Shoulder Arthritis
4 Patients Enrolled for Shoulder Arthritis

Frequently Asked Questions

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

Is the age limit of this clinical trial twenty-five years or higher?

"The upper and lower boundary for participant eligibility is 50 to 90 years old respectively."

Answered by AI

What criteria must a participant fulfill to become eligible for this trial?

"Eligibility for this research project is limited to individuals aged 50 - 90 with glenohumeral joint degeneration. The total enrollment target is 220 participants."

Answered by AI

Is this study actively seeking participants?

"According to clinicaltrials.gov, this current medical trial is actively looking for participants. The study was published on April 1st 2016 and the most recent update came through on March 7th 2022."

Answered by AI

How many individuals are enrolled as participants in this experiment?

"Affirmative. According to clinicaltrials.gov, this current medical trial is actively recruiting candidates between 1 location and the initial posting was on April 1st 2016 with a recent update on March 7th 2022. The study requires 220 participants in total."

Answered by AI
~13 spots leftby Mar 2025