Shoulder Arthritis, Shoulder Disease, Shoulder Fractures, Shoulder Injuries, Shoulder Pain
Conditions
Brief summary
The objective of this retrospective and prospective consecutive series PMCF (Post Market Clinical Follow Up) study is to collect long-term data confirming safety, performance and clinical benefits of the Comprehensive Primary Revision Stems (implants and instrumentation) when used for shoulder arthroplasty at 1, 3, 5, 7 and 10 years.
Detailed description
The safety of this device will be assessed by analyzing implant survivorship. This will be established by recording the incidence and frequency of revisions, complications, and adverse events. Relation of the events to implant, instrumentation and/or procedure should be specified. The performance will be evaluated by assessment of reported clinical outcome measures (PROMs) as well as radiographic outcomes.
Interventions
DEVICEComprehensive Primary Revision Stems
Comprehensive Primary Revision Stem (implants and instrumentation) when used for shoulder arthroplasty.
Sponsors
Zimmer Biomet
Study design
Observational model
OTHER
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
Inclusion criteria
* Patient must be 18 years of age or older. * Patient must be willing and able to follow directions. * Study devices must have been implanted following the surgical technique and IFU for the Comprehensive Revision Stem
Exclusion criteria
* Off-label use. * Patient is a prisoner. * Patient is a current alcohol or drug abuser. * Patient has a psychiatric illness or cognitive deficit that will not allow for proper informed consent. * Patient is unwilling to sign informed consent. * Uncooperative patient or patient with neurologic disorders who are incapable of following directions.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Implant Survivorship at 10 years follow-up (Kaplan Meier) | 10 years | Based on removal or intended removal of the device and determined using the Kaplan-Meier method. |
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Device Performance and Benefits evaluated through the Western Ontario Arthritis of the Shoulder (WOOS) outcome measure. | 10 years | The secondary objective is the assessment of performance and clinical benefits by recording patient reported clinical outcome measures (PROMs), through the use of the Western Ontario Osteoarthritis of the Should Score (WOOS). The WOOS is a 19 item questionnaire. Patients rate their symptoms from no pain extreme pain. The total score is calculated where 0 is a normal healthy shoulder and 1900 is the worst possible result. WOOS% (% of raw score) can be calculated using the formula (1900 - the score)/19 and then 0% is the worst possible result and 100% is the best possible result. |
Countries
Denmark, United States
Contacts
STUDY_DIRECTORRyan Boylan, MBA
Zimmer Biomet
Outcome results
None listed