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NCT06788717 | RECRUITING | Shoulder Pain

MDR - Comprehensive Primary Revision Stems PMCF
Sponsor:

Zimmer Biomet

Brief 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.

Condition or disease

Shoulder Pain

Shoulder Injuries

Shoulder Fractures

Shoulder Disease

Shoulder Arthritis

Intervention/treatment

Comprehensive Primary Revision Stems

Detailed 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.

Study Type : OBSERVATIONAL
Estimated Enrollment : 59 participants
Official Title : 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
Actual Study Start Date : 2025-06-19
Estimated Primary Completion Date : 2035-07
Estimated Study Completion Date : 2040-12

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years to 100 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
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.
    • MDR - Comprehensive Primary Revision Stems PMCF

    Location Details

    NCT06788717

    Please Choose a site

    How to Participate

    Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

    Locations

    RECRUITING

    United States, California

    Cedars Sinai Medical Center

    Los Angeles, California, United States, 900033

    RECRUITING

    Denmark,

    Aalborg University Hospital

    Aalborg, Denmark, DK-9000