Post-market Clinical Follow-up Study to Provide Safety, Performance and Clinical Benefits Data of the Comprehensive® Primary Revision Stems (Implants and Instrumentation) - A Retrospective and Prospective Consecutive Series Study
Zimmer Biomet
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.
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.
Eligibility
- Age range
- 18–100 years
- Sex
- All
- 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 dire…
Interventions
- DeviceComprehensive Primary Revision Stems
Comprehensive Primary Revision Stem (implants and instrumentation) when used for shoulder arthroplasty.
Locations (2)
- Cedars Sinai Medical CenterLos Angeles, California
- Aalborg University HospitalAalborg