MDR - Comprehensive Primary Revision Stems PMCF
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-100
SponsorZimmer Biomet
About this trial
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 criteria
Qualifiers
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
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Comprehensive Primary Revision Stems
Treatment groups
59 Participants
are divided into 1 treatment groupLocations
2Denmark
Aalborg University HospitalDK-9000, Aalborg Denmark
United States
Cedars Sinai Medical Center900033, Los AngelesCalifornia, United States
Sponsors and collaborators
Zimmer Biomet
Lead sponsor
Source ClinicalTrials.gov