MDR - Comprehensive Primary Revision Stems PMCF

Enrolling by invitation

Conditions studied: Shoulder Pain, Shoulder Injuries, Shoulder Fractures, Shoulder Disease, Shoulder Arthritis

In brief

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.

Key facts

Study ID

NCT06788717

Run by

Zimmer Biomet

People needed

59

Starts

2025-06-19

Expected to finish

2040-12-01

Last updated by the study team

2026-07-09

Who can join

Age: 18 and older, up to 100. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Cedars Sinai Medical Center — Los Angeles, California, United States
• Aalborg University Hospital — Aalborg, Denmark

Full record on ClinicalTrials.gov

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