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
This trial does not accept healthy volunteersQualifiers
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 population
Consecutive series of subjects implanted with the Comprehensive Primary Revision Stems according to the approved indications will be identified and invited to participate in the study.
Trial design
Design model
Other
Time perspective
Other
Treatments tested in this trial
Comprehensive Primary Revision Stems
DeviceComprehensive Primary Revision Stem (implants and instrumentation) when used for shoulder arthroplasty.
Treatment groups
59 Participants
are divided into 1 treatment groupGroup A: Treatment Group1 intervention
Trial outcomes
Primary outcomes
1
Implant Survivorship at 10 years follow-up (Kaplan Meier)
Based on removal or intended removal of the device and determined using the Kaplan-Meier method.
Time frame
10 years2
Frequency and Incidence of Adverse Events (Safety)
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.
Time frame
10 yearsSecondary outcomes
1
Device Performance and Benefits evaluated through the Western Ontario Arthritis of the Shoulder (WOOS) outcome measure.
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.
Time frame
10 yearsSponsors and contacts
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Source ClinicalTrials.gov