Comprehensive Primary Revision Stems: Comprehensive Primary Revision Stem (implants and instrumentation) when used for shoulder arthroplasty.
Study 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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
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.
Primary outcome measure(s)
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.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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