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Study of Comprehensive Primary Revision Stems for Shoulder Conditions

This study is looking at how well the Comprehensive Primary Revision Stems (implants and tools used in shoulder replacement surgery) work over a long period. It aims to confirm their safety and benefits for people with shoulder pain, injuries, fractures, disease, or arthritis. You could be eligible if you are 18 to 100 years old and have already had these specific devices implanted following surgical guidelines. The study will track how long the implants last and any problems that occur over 10 years. The current recruitment status is unclear.

Study design
This is an observational study, meaning researchers will collect information without assigning treatments. It plans to enroll 59 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for 10 years to assess implant survivorship and adverse events.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06788717

MDR - Comprehensive Primary Revision Stems PMCF

Enrolling by Invitation
Not specifiedAges 18+Observational
Zimmer Biomet
~59 participants
Updated 2026-07-09 on ClinicalTrials.gov
What's tested:Comprehensive Primary Revision Stems

At a glance

Recruiting sites
0 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Implant Survivorship at 10 years follow-up (Kaplan Meier)
Measured over 10 years
+1 more outcome measured

Conditions

Shoulder Pain
Shoulder Injuries
Shoulder Fractures
Shoulder Disease
Shoulder Arthritis

Explore related trials

Diffuse Cerebral Sclerosis of SchilderInjury of shoulder regionShoulder arthritisShoulder FractureShoulder Pain

Where it's being run

2 sites across 2 states
California1
Denmark1

Study leadership

  • Ryan Boylan, MBA · STUDY_DIRECTOR · Zimmer Biomet

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • 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.