What this study is
The objectives of this study are to confirm the safety, performance, and clinical benefits of Zimmer Biomet Shoulder Arthroplasty Systems and its instrumentation in primary or revision shoulder arthroplasty. These objectives will be assessed using standard scoring systems, radiographic evidence, and adverse event records. Safety of the system will be assessed by monitoring the frequency an incidence of adverse events.
What's being tested
- Alliance Glenoid
Intervention · DEVICE
Alliance Glenoid used in Primary or Revision Total Shoulder Arthroplasty
- Identity Stem
Intervention · DEVICE
Identity Shoulder System is intended to be used in anatomic total shoulder arthroplasty, shoulder hemi-arthroplasty, or total reverse shoulder arthroplasty in both Primary or Revision Total Shoulder Arthroplasty
Study details
- Official title
- Zimmer Biomet Shoulder Arthroplasty Long-term Post Market Clinical Follow-up Study
- Sponsor
- Zimmer Biomet
- Conditions
- Shoulder Fractures · Shoulder Arthritis · Shoulder Osteoarthritis · Shoulder Deformity · Shoulder Injuries · Shoulder Pain
- Enrolling
- 584 people
- Starts
- 2021-07-28
- Est. completion
- 2033-08-15
- Design
- Open-label, single group
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 20 Years and overSex ALLHealthy volunteers Not acceptedYou may qualify if
- 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 methods of treatment are deemed inadequate.; Difficult clinical management problems, where other methods of treatment may not be suitable or may be inadequate.
- 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, (for reverse application); With severe arthropathy and/or; Previously failed shoulder joint replacement
- Patient must have functional deltoid muscle (for reverse application)
You can't join if
- Patient is unwilling or unable to give consent or to comply with the follow-up program.
- Patient has any condition which would in the judgement of the Investigator, place the patient at undue risk or interfere with the study.
- Patient is known to be pregnant or breastfeeding.
- Patient is a vulnerable subject (prisoner, mentally incompetent or unable to understand what participation to the study entails, a known alcohol or drug abuser, and/or anticipated to be non-compliant).
- Patient is uncooperative or patient with neurologic disorders who is incapable or unwilling to follow directions.
- Patient has any sign of infection affecting the shoulder joint or in its proximity which may spread to the implant site.
- Patient has rapid joint destruction, marked bone loss, or bone resorption apparent on roentgenogram.
- Patient has any neuromuscular disease compromising the affected limb that would render the procedure unjustifiable.
- Patient presents with osteoporosis, which in the opinion of the Investigator, may limit the subject's ability to support total shoulder arthroplasty using the study device.
- Patient has osteomalacia.
- Patient has a metabolic disorder that may impair bone formation.
- Patient has deficient rotator cuff.
- Patient presents with significant injury to the upper brachial plexus.
- Patient has paralysis of the axillary nerve.
- Patient has non-functional deltoid or external rotator muscles.
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (17)
2 openPanorama Orthopaedic and Spine Center
Golden, Colorado, United States
- Paul Lee, PA · Contact720-497-6697ResearchCoordinators@panoramaortho.com
- ContactResearchCoordinators@panoramaortho.com
- David Schneider, MD · Principal investigator
- James Johnson, MD · Sub-investigator
RecruitingIntermountain Health
Murray, Utah, United States
- Maha Maleki, BS · Contact801-507-8095Maha.Maleki@imail.org
- Matt Schneider, MS · Contact801-507-8095Matthew.Schneider@imail.org
- Aaron Chamberlain, MD · Principal investigator
RecruitingHoag Orthopedic Institute
Irvine, California, United States
Active, not recruitingNorthwestern University
Chicago, Illinois, United States
Active, not recruitingNorton Healthcare, Inc
Louisville, Kentucky, United States
TerminatedWilliam Beaumont Hospital
Royal Oak, Michigan, United States
Active, not recruitingTRIA Orthopaedic Center Research Institute
Bloomington, Minnesota, United States
Active, not recruitingMississippi Sports Medicine and Orthopaedic Center, PLLC
Jackson, Mississippi, United States
Active, not recruitingAdvance Bone and Joint
City of Saint Peters, Missouri, United States
Active, not recruitingWashington University
St Louis, Missouri, United States
Active, not recruitingUniversity of Buffalo
Buffalo, New York, United States
Active, not recruitingRothman Institute
Philadelphia, Pennsylvania, United States
Active, not recruiting
5 sites outside the US
Fukui General Hospital
Fukui, Japan
Active, not recruitingIwaki City Medical Center
Fukushima, Japan
Active, not recruitingYuuai Medical Center
Okinawa, Japan
Active, not recruitingKichijoji Minami Hospital
Tokyo, Japan
WithdrawnKensington Private Hospital
Whangarei, New Zealand
Withdrawn
Study team
Sponsor
Zimmer Biomet
Study ID CMU2019-35E
Study director
Ryan Boylan
Zimmer Biomet
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.