MDR - Comprehensive Primary Revision Stems PMCF

April 22, 2026 updated by: Zimmer Biomet

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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

Enrollment (Estimated)

59

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Denmark
      • Aalborg, Denmark, DK-9000
        • Recruiting
        • Aalborg University Hospital
        • Contact:
        • Principal Investigator:
          • SteenLund Jensen, MD
  • United States
    • California
      • Los Angeles, California, United States, 900033

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Consecutive series of subjects implanted with the Comprehensive Primary Revision Stems according to the approved indications will be identified and invited to participate in the study.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Treatment Group
The study population will comprise a consecutive cohort of 59 cases (males and females), implanted with the Comprehensive Primary Revision Stem.
Device: Comprehensive Primary Revision Stems
Comprehensive Primary Revision Stem (implants and instrumentation) when used for shoulder arthroplasty.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Implant Survivorship at 10 years follow-up (Kaplan Meier)
Time Frame: 10 years
Based on removal or intended removal of the device and determined using the Kaplan-Meier method.
10 years
Frequency and Incidence of Adverse Events (Safety)
Time Frame: 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.
10 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Device Performance and Benefits evaluated through the Western Ontario Arthritis of the Shoulder (WOOS) outcome measure.
Time Frame: 10 years
The secondary objective is the assessment of performance and clinical benefits by recording patient reported clinical outcome measures (PROMs), through the use of the Western Ontario Osteoarthritis of the Should Score (WOOS). The WOOS is a 19 item questionnaire. Patients rate their symptoms from no pain extreme pain. The total score is calculated where 0 is a normal healthy shoulder and 1900 is the worst possible result. WOOS% (% of raw score) can be calculated using the formula (1900 - the score)/19 and then 0% is the worst possible result and 100% is the best possible result.
10 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zimmer Biomet

Investigators

  • Study Director: Ryan Boylan, MBA, Zimmer Biomet

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 19, 2025

Primary Completion (Estimated)

July 1, 2035

Study Completion (Estimated)

December 1, 2040

Study Registration Dates

First Submitted

January 17, 2025

First Submitted That Met QC Criteria

January 17, 2025

First Posted (Actual)

January 23, 2025

Study Record Updates

Last Update Posted (Actual)

April 28, 2026

Last Update Submitted That Met QC Criteria

April 22, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MDRG2017-89MS-50E

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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