Arthritis Shoulder, Degenerative Joint Disease, Shoulder Arthritis Osteoarthritis, Shoulder Fractures, Shoulder Injury, Shoulder Pain
Conditions
Keywords
medical device, PMCF, Anatomic Total Shoulder Arthroplasty
Brief summary
This is a multicenter, prospective, non-controlled post market surveillance study. The objectives of this study are to confirm the safety, performance, and clinical benefits of the Zimmer Biomet Shoulder Arthroplasty systems in primary anatomic shoulder arthroplasty and its instrumentation. Safety of the systems will be assessed by monitoring the frequency and incidence of adverse events. The performance and clinical benefits will be evaluated by assessment of the overall pain and functional performance, qualify of life, and radiographic parameters of all enrolled study subjects.
Detailed description
The primary endpoint for this study will be performance assessed by improvement in the American Shoulder and Elbow Surgeons (ASES) shoulder score from baseline to 2 years (as evaluated using the overall cohort mean showing at least the minimal clinically important difference (MCID) of 6.4 points). The secondary endpoint is represented by the safety of the system, which will be assessed by monitoring the frequency and incidence of adverse events. The secondary endpoint evaluation will also assess the overall pain, functional performance, quality of life and radiographic parameters of all enrolled study subjects.
Interventions
DEVICEAlliance™ Glenoid
Total Shoulder Arthroplasty using the Alliance™ Glenoid implant
Sponsors
Zimmer Biomet
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion 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. Fractures of the proximal humerus, where other methods of treatment are deemed inadequate. Difficult clinical management problems, where other method 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.
Exclusion criteria
* 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 a metabolic disorder that may impair bone formation. * Patient has osteomalacia.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| American Shoulder and Elbow Surgeons (ASES) | 2 years | The primary endpoint for this study will be performance assessed by improvement in the American Shoulder and Elbow Surgeons (ASES) shoulder score from baseline to 2 years (as evaluated using the overall cohort mean showing at least the minimal clinically important difference (MCID) of 6.4 points). 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Frequency and Incidence of Adverse Events (Safety) | 10 years | 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. |
| Euroqol Patient Quality of life (EQ-5D-5L) | 10 years | 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. |
| Radiographic Performance | 10 years | X-Rays will be evaluated for radiolucency, osteolysis, osteophytes, component migration, subsidence and heterotopic ossification. |
Countries
Germany, Netherlands
Contacts
CONTACTCarina Hafner
CONTACTLisa To
STUDY_DIRECTOREmilie Rohmer
Zimmer Biomet
Outcome results
None listed