MDR - Comprehensive Primary Revision Stems PMCF

NCT ID: NCT06788717

Last Updated: 2025-07-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

59 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-06-19

Study Completion Date

2040-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Shoulder Pain Shoulder Injuries Shoulder Fractures Shoulder Disease Shoulder Arthritis

Study Design

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Observational Model Type

OTHER

Study Time Perspective

OTHER

Study Groups

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Treatment Group

The study population will comprise a consecutive cohort of 59 cases (males and females), implanted with the Comprehensive Primary Revision Stem.

Comprehensive Primary Revision Stems

Intervention Type DEVICE

Comprehensive Primary Revision Stem (implants and instrumentation) when used for shoulder arthroplasty.

Interventions

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Comprehensive Primary Revision Stems

Comprehensive Primary Revision Stem (implants and instrumentation) when used for shoulder arthroplasty.

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Zimmer Biomet

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ryan Boylan, MBA

Role: STUDY_DIRECTOR

Zimmer Biomet

Locations

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Cedars Sinai Medical Center

Los Angeles, California, United States

Site Status RECRUITING

Aalborg University Hospital

Aalborg, , Denmark

Site Status RECRUITING

Countries

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United States Denmark

Central Contacts

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Octavia Gladden

Role: CONTACT

7044930178

Facility Contacts

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Ali Zafar

Role: primary

Julie Nicoux

Role: primary

+33 06 72 61 35 02

Other Identifiers

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MDRG2017-89MS-50E

Identifier Type: -

Identifier Source: org_study_id

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