Actively Recruiting
Zimmer Biomet Shoulder Arthroplasty Long-term Post Market Clinical Follow-up Study
Led by Zimmer Biomet · Updated on 2026-04-28
584
Participants Needed
17
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety, performance, and clinical benefits of Zimmer Biomet Shoulder Arthroplasty Systems and its instruments in patients undergoing primary or revision shoulder arthroplasty. The study aims to confirm implant survival over 10 years, monitor adverse events, and assess improvements in shoulder function, pain, quality of life, and radiographic outcomes using standard scoring systems and imaging. Participants will receive the Zimmer Biomet Total Shoulder Arthroplasty System, including devices like the Alliance Glenoid and Identity Stem, designed for various types of shoulder replacements. The study will follow patients for 10 years to track implant survival and safety, with a 2-year evaluation focusing on clinical performance and radiographic measures. During the study, patients will undergo assessments of implant survival using the Kaplan Meier method, adverse event monitoring, and evaluations of shoulder function with the American Shoulder and Elbow Surgeons (ASES) score, quality of life questionnaires, and detailed radiographic imaging. Follow-up visits at 2 years and up to 10 years will help researchers understand the long-term results of the shoulder arthroplasty system.
CONDITIONS
Brief Title
Zimmer Biomet Shoulder Arthroplasty PMCF
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient must be 20 years of age or older.
- Patient must be anatomically and structurally suited to receive shoulder arthroplasty implants.
- Patient is a candidate for shoulder arthroplasty due to one or more of the following: non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis, rheumatoid arthritis, correction of functional deformity, fractures of the proximal humerus where other treatments are inadequate, or difficult clinical management problems.
- Patient must be able and willing to complete the protocol-required follow-up.
- Patient must be able and willing to sign the IRB/EC approved informed consent.
- Patient has grossly deficient rotator cuff with severe arthropathy and/or previously failed shoulder joint replacement (for reverse application).
- Patient must have functional deltoid muscle (for reverse application).
You will not qualify if you...
- Patient is unwilling or unable to give consent or comply with the follow-up program.
- Patient has any condition placing them at undue risk or interfering with the study, according to the Investigator.
- Patient is known to be pregnant or breastfeeding.
- Patient is a vulnerable subject such as prisoner, mentally incompetent, known alcohol or drug abuser, or anticipated to be non-compliant.
- Patient is uncooperative or has neurologic disorders impairing ability to follow directions.
- Patient has any infection affecting the shoulder joint or nearby area that may spread to the implant site.
- Patient has rapid joint destruction, marked bone loss, or bone resorption seen on imaging.
- Patient has neuromuscular disease compromising the affected limb making the procedure unjustifiable.
- Patient has osteoporosis that limits support for the shoulder arthroplasty device.
- Patient has osteomalacia.
- Patient has a metabolic disorder impairing bone formation.
- Patient has deficient rotator cuff.
- Patient has significant injury to the upper brachial plexus.
- Patient has paralysis of the axillary nerve.
- Patient has non-functional deltoid or external rotator muscles.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day to 2 weeks
Participants undergo shoulder arthroplasty with the Zimmer Biomet Total Shoulder Arthroplasty System and receive immediate post-operative care.
1 surgical visit and immediate post-operative assessments
Duration - Up to 10 years
Participants are followed over time to assess implant performance, clinical benefits, and safety.
Regular follow-up visits over 10 years including assessments at 2 years
Trial Site Locations
Total: 17 locations
1
Hoag Orthopedic Institute
Irvine, California, United States, 92618
Active, Not Recruiting
2
Panorama Orthopaedic and Spine Center
Golden, Colorado, United States, 80401
Actively Recruiting
3
Northwestern University
Chicago, Illinois, United States, 60208
Active, Not Recruiting
4
Norton Healthcare, Inc
Louisville, Kentucky, United States, 40202
Terminated
5
William Beaumont Hospital
Royal Oak, Michigan, United States, 48073
Active, Not Recruiting
6
TRIA Orthopaedic Center Research Institute
Bloomington, Minnesota, United States, 55431
Active, Not Recruiting
7
Mississippi Sports Medicine and Orthopaedic Center, PLLC
Jackson, Mississippi, United States, 39202
Active, Not Recruiting
8
Advance Bone and Joint
City of Saint Peters, Missouri, United States, 63376
Active, Not Recruiting
9
Washington University
St Louis, Missouri, United States, 63130
Active, Not Recruiting
10
University of Buffalo
Buffalo, New York, United States, 14215
Active, Not Recruiting
11
Rothman Institute
Philadelphia, Pennsylvania, United States, 19107
Active, Not Recruiting
12
Intermountain Health
Murray, Utah, United States, 84107
Actively Recruiting
13
Fukui General Hospital
Fukui, Japan, 910-3113
Active, Not Recruiting
14
Iwaki City Medical Center
Fukushima, Japan, 973-8555
Active, Not Recruiting
15
Yuuai Medical Center
Okinawa, Japan, 901-0224
Active, Not Recruiting
16
Kichijoji Minami Hospital
Tokyo, Japan, 180-0003
Withdrawn
17
Kensington Private Hospital
Whangarei, New Zealand, 0112
Withdrawn
Research Team
C
Cayla Lafollette, BS
R
Ryan Boylan, MBA
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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