BridgeMD
New treatment option for Shoulder Fractures
Official title Zimmer Biomet Shoulder Arthroplasty PMCF
ClinicalTrials.gov ID: NCT04984291
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 20 and older
You may be able to join 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.
You likely 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...
- 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.
See the full eligibility criteria
- 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)
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Irvine, California, United States
- Golden, Colorado, United States
- Chicago, Illinois, United States
- Louisville, Kentucky, United States
- Royal Oak, Michigan, United States
- Bloomington, Minnesota, United States
- Jackson, Mississippi, United States
- City of Saint Peters, Missouri, United States
- St Louis, Missouri, United States
- Buffalo, New York, United States
- Philadelphia, Pennsylvania, United States
- Murray, Utah, United States
- Fukui, Japan
- Fukushima, Japan
- Okinawa, Japan
- Tokyo, Japan
- Whangarei, New Zealand
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 20 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Irvine, California, United States; Golden, Colorado, United States; Chicago, Illinois, United States; Louisville, Kentucky, United States; Royal Oak, Michigan, United States; Bloomington, Minnesota, United States and 11 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.