RecruitingNot Applicable

MDR - Comprehensive Primary Revision Stems PMCF

United States, Denmark59 participantsStarted 2025-06-19

Plain-language 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.

Who can participate

Age range18 Years – 100 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

Implant Survivorship at 10 years follow-up (Kaplan Meier)

Timeframe: 10 years

Frequency and Incidence of Adverse Events (Safety)

Timeframe: 10 years

Trial details

NCT IDNCT06788717

SponsorZimmer Biomet

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2035-07

Contact for this trial

Octavia Gladden

7044930178 octavia.gladden@zimmerbiomet.com

View on ClinicalTrials.gov More Shoulder Pain trials