Shoulder FracturesNCT04984291
Zimmer Biomet Shoulder Arthroplasty PMCF
A study testing Alliance Glenoid and Identity Stem in people with Shoulder Fractures and Shoulder Arthritis, run by Zimmer Biomet at 17 sites in 3 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Shoulder Fractures, Shoulder Arthritis, Shoulder Osteoarthritis
- What is being tested?
- Alliance Glenoid and Identity Stem
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 584 participants
- Where
- 17 sitesin 3 countries
- Study dates
- 28 Jul 2021to 15 Aug 2033
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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)
Who cannot join
- 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.
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- 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.
Trial locations and contacts
17 sites in 3 countries. Contact the study team or a site near you to ask about taking part.
Ryan Boylan, MBA contact
17 sites in 3 countries
United States12 sites, 2 recruiting
- Active, not recruiting
TRIA Orthopaedic Center Research Institute
Bloomington, Minnesota, 55431
- Active, not recruiting
University of Buffalo
Buffalo, New York, 14215
- Active, not recruiting
Northwestern University
Chicago, Illinois, 60208
- Active, not recruiting
Advance Bone and Joint
City of Saint Peters, Missouri, 63376
- Recruiting
Panorama Orthopaedic and Spine Center
Golden, Colorado, 80401
Paul Lee, PA, 720-497-6697, ResearchCoordinators@panoramaortho.com
ResearchCoordinators@panoramaortho.com
- Active, not recruiting
Hoag Orthopedic Institute
Irvine, California, 92618
- Active, not recruiting
Mississippi Sports Medicine and Orthopaedic Center, PLLC
Jackson, Mississippi, 39202
- Terminated
Norton Healthcare, Inc
Louisville, Kentucky, 40202
- Recruiting
Intermountain Health
Murray, Utah, 84107
Maha Maleki, BS, 801-507-8095, Maha.Maleki@imail.org
Matt Schneider, MS, 801-507-8095, Matthew.Schneider@imail.org
- Active, not recruiting
Rothman Institute
Philadelphia, Pennsylvania, 19107
- Active, not recruiting
William Beaumont Hospital
Royal Oak, Michigan, 48073
- Active, not recruiting
Washington University
St Louis, Missouri, 63130
Japan4 sites
- Active, not recruiting
Fukui General Hospital
Fukui, 910-3113
- Active, not recruiting
Iwaki City Medical Center
Fukushima, 973-8555
- Active, not recruiting
Yuuai Medical Center
Okinawa, 901-0224
- Withdrawn
Kichijoji Minami Hospital
Tokyo, 180-0003
About this study
Official title: Zimmer Biomet Shoulder Arthroplasty Long-term Post Market Clinical Follow-up Study
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.
Read the detailed description
The primary endpoint is defined as survival of the implant at 10 years, which is based on removal or intended removal of at least 1-study implant component and will be determined by using the Kaplan Meier method. The safety of the system will be assessed by monitoring the frequency and incidence of adverse events. Separate analysis will be done for each arm of the study.
The secondary endpoint is represented by the performance and clinical benefits of Zimmer Biomet Shoulder Arthroplasty Systems and its instrumentation after 2 years, which will be assessed by the American Shoulder and Elbow Surgeons (ASES) shoulder score. The secondary endpoint evaluation will also assess the overall pain, functional performance, quality of life and radiographic parameters of all enrolled study subjects.
- Conditions
- Shoulder Fractures, Shoulder Arthritis, Shoulder Osteoarthritis, Shoulder Deformity, Shoulder Injuries, Shoulder Pain
- Being tested
- Alliance Glenoid, Identity Stem
- Keywords
- Total Shoulder Arthroplasty, Glenoid, Humeral Stem, Stem Adapter, Humeral Head, Humeral Bearing, Humeral Trays, Head Adapter, Reverse, Anatomic, Hemi
- Medical subject headings
- Shoulder Fractures, Shoulder Injuries, Shoulder Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alliance GlenoidDevice
Also called Alliance
Alliance Glenoid used in Primary or Revision Total Shoulder Arthroplasty
Identity StemDevice
Also called Identity
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 group | Role | What they receive |
|---|---|---|
| Zimmer Biomet Total Shoulder Arthroplasty System | Experimental | Patients who are having primary or revision total shoulder arthroplasty who will receive a Zimmer Biomet Total Shoulder Arthroplasty System. Receives: Device: Alliance Glenoid; Device: Identity Stem |
What is being measured
The primary outcome is the main question the study is designed to answer.
Implant Survivorship at 10 years follow-up (Kaplan Meier)
Based on removal or intended removal of the device and determined using the Kaplan-Meier method.
Measured: 10 years
Frequency and Incidence of Adverse Events (Safety)
Monitoring the frequency and incidence of adverse events, serious adverse events, adverse device effects, serious adverse device effects, and unanticipated serious adverse device effects as well as device deficiencies.
Measured: 10 years
Secondary outcomes (7)
Clinical efficacy of the device is assessed using the American Shoulder and Elbow Surgeons (ASES) Shoulder Score at 2 years follow-up
Pain, function, and activities of daily living are measured. The ASES scale is 0-100. 100 is the highest score and indicates the greatest function while 0 is the lowest score.
Measured: 2 years
Euroqol Patient Quality of life measured at 2 years follow-up (EQ-5D-5L)
The EuroQol five dimensions questionnaire (EQ-5D-5L) is a five dimensional self-assessment that is comprised of mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. These five dimensions can be used to index a subject's health utility on a scale of 0 to 1, where 0 is death and 1 is perfect health. The scoring rule for EQ-5D permits scores less than 0, implying that some health states may be worse than death.
Measured: 2 years
Radiographic Performance [Radiolucency] at 2 years follow-up
X-rays will be evaluated for radiolucency lines to show the number of subjects with radiolucency. Radiolucency refers to structures that are less dense and permit the x-ray beam to pass through them. Radiolucent structures appear dark or black in the radiographic image.
Measured: 2 years
Radiographic Performance [Osteolysis] at 2 years follow-up
X-rays will be evaluated for osteolysis to show the number of subjects with osteolysis. Osteolysis is a progressive condition where bone tissue is destroyed. In this process, bones lose minerals (mostly calcium), softens, degenerates and become weaker.
Measured: 2 years
Radiographic Performance [Heterotopic Ossification] at 2 years follow-up
X-rays will be evaluated for heterotopic ossification to show the number of subjects with heterotopic ossification. Heterotopic ossification refers to the presence of bone in soft tissue where bone normally does not exist (extraskeletal bone).
Measured: 2 years
Radiographic Performance [Humeral Component Subsidence] at 2 years follow-up
X-rays will be evaluated for humeral component subsidence to show the number of subjects with subsidence. Component Subsidence refers to the presence of the device component gradually sinking or caving into the bone structure.
Measured: 2 year
Radiographic Performance [Glenoid Component Migration] at 2 years follow-up
X-rays will be evaluated for glenoid component migration to show the number of subjects with migration. Component migration refers to the presence of the device component gradually moving anteriorly, posteriorly, superiorly, or inferiorly in relation to original placement.
Measured: 2 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2021
- Study start28 Jul 2021
- Primary completion15 Aug 2033 (estimated)
- Study completion15 Aug 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Shoulder FracturesStudies of the same condition, open and under way.
- More trials run by Zimmer BiometThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 584 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zimmer Biomet
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ryan Boylan, Study director, Zimmer Biomet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04984291
- Sponsor's protocol ID
- CMU2019-35E
- Status last verified
- Apr 2026
- First submitted
- 16 Jul 2021
- Last updated
- 28 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes