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Clinical Trials in the USA / NCT06788717
Enrolling by invitation Observational

MDR - Comprehensive Primary Revision Stems PMCF

NCT06788717 · tracked via the Priya Life Science USA tracker
Sponsor
Zimmer Biomet
Phase
Observational
Started
2025-06-19
Last updated
2026-07-09

Condition(s) studied

Shoulder PainShoulder InjuriesShoulder FracturesShoulder DiseaseShoulder Arthritis

Investigational drug(s) / intervention(s)

Comprehensive Primary Revision Stems

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.

Trial sites (2)

FacilityCityRegionStatus
Cedars Sinai Medical Center Los Angeles California
Aalborg University Hospital Aalborg Denmark

More Zimmer Biomet trials in the USA

Persona Total Knee Arthroplasty Outcomes Study Active, not recruiting
Post Market Clinical Follow-up (PMCF) Study of the A.L.P.S. Proximal Humerus Plating System Active, not recruiting
Prospective G7 Dual Mobility Total Hip PMCF Active, not recruiting
Avenir Complete Post-Market Clinical Follow-Up Study Active, not recruiting
Embody Post-Market Clinical Follow-Up Study Active, not recruiting

Other trials for the same condition

SportsPro: Post-Market Clinical Follow Up Study Recruiting
OsseoFit Stemless Shoulder System (Anatomic) Enrolling by invitation
MDR - Comprehensive Reverse/Versa Dial Ti Glenosphere Enrolling by invitation
MDR - Comprehensive Primary/Micro Stem & Versa-Dial Ti Humeral Head Enrolling by invitation
JuggerKnot With Broadband PMCF Study Active, not recruiting
Official registry record

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.

View NCT06788717 on ClinicalTrials.gov ↗ ← All trials in the USA