Long-term follow-up of Zimmer Biomet shoulder replacement systems for shoulder problems
Follows adults receiving shoulder replacement implants to check safety and how well they work.
Key facts
- Who runs it
- Zimmer Biomet
- Where
- Fukui, Fukushima, Okinawa, and Tokyo, JapanSee the 4 sitesAlso in 2 other countries, 13 sites
- Trial code
- Registry title
- Zimmer Biomet Shoulder Arthroplasty PMCF
- Status
- Recruiting
- People taking part
- 584 people, planned
- Started
- 28 Jul 2021
- Expected to end
- 15 Aug 2033
- Type of study
- Interventional
- Treatments tested
- Alliance Glenoid
- Identity Stem
- Record updated
- 28 April 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults who need a first or repeat shoulder joint replacement with a Zimmer Biomet shoulder system.
- Age
- 20 years or older.
- Sex
- All sexes can join.
- Disease stage
- People who need shoulder replacement because of joint wear (osteoarthritis, avascular necrosis), rheumatoid arthritis, a joint deformity, an upper arm bone fracture, or other hard-to-treat shoulder problems. For a reverse shoulder replacement: a badly damaged rotator cuff with severe joint disease or a failed earlier shoulder replacement, and a working deltoid muscle.
- Earlier treatment
- A previous shoulder replacement is allowed (repeat surgery).
Main reasons for not taking part
- Pregnancy or breastfeeding.
- Infection in or near the shoulder joint.
- Fast joint destruction, marked bone loss, osteoporosis that limits the implant, osteomalacia, or a bone-forming metabolic disorder.
- Nerve or muscle disease of the arm, upper brachial plexus injury, axillary nerve paralysis, or non-working deltoid or external rotator muscles.
- Unable to give consent or follow the study visits.
The registry criteria, word for word
Show all 22 criteriaShow less
Who can take part
- 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)
Who cannot take part
- 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 has any condition which would in the judgement of the Investigator, place the patient at undue risk or interfere with the study
- 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 any neuromuscular disease compromising the affected limb that would render the procedure unjustifiable
- Patient has a metabolic disorder that may impair bone formation
- Patient is unwilling or unable to give consent or to comply with the follow-up program
- Patient is known to be pregnant or breastfeeding
- Patient has rapid joint destruction, marked bone loss, or bone resorption apparent on roentgenogram
- 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 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
Where in Japan
Also in 2 other countries, 13 sites
- Fukui General HospitalFukui, JapanContact: Cayla Lafollette, BSNo longer taking part
- Iwaki City Medical CenterFukushima, JapanContact: Cayla Lafollette, BSNo longer taking part
- Yuuai Medical CenterOkinawa, JapanContact: Cayla Lafollette, BSNo longer taking part
- Kichijoji Minami HospitalTokyo, JapanContact: Cayla Lafollette, BSNo longer taking part
About the trial
What the trial wants to find out
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.
The group in the trial
- Zimmer Biomet Total Shoulder Arthroplasty SystemTreatment being tested
Patients who are having primary or revision total shoulder arthroplasty who will receive a Zimmer Biomet Total Shoulder Arthroplasty System.
Treatment: Alliance Glenoid and Identity Stem
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Zimmer Biomet Shoulder Arthroplasty Long-term Post Market Clinical Follow-up Study
- Plain-language title
- Long-term follow-up of Zimmer Biomet shoulder replacement systems for shoulder problemsGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 14 November 2026.
- Record updated
- 28 April 2026