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Enrolling by invitation NCT06788717

MDR - Comprehensive Primary Revision Stems PMCF

— Observational Shoulder Pain Shoulder Injuries Shoulder Fractures Shoulder Disease

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Comprehensive Primary Revision Stems.
Who it may be relevant to
Registry conditions: Shoulder Pain, Shoulder Injuries, Shoulder Fractures, Shoulder Disease. Basic parameters: 18 years — 100 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States, Denmark
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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

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.

Interventions

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

Primary outcome measures

  • Implant Survivorship at 10 years follow-up (Kaplan Meier) [Time frame: 10 years]
  • Frequency and Incidence of Adverse Events (Safety) [Time frame: 10 years]
Secondary outcome measures (1)
  • Device Performance and Benefits evaluated through the Western Ontario Arthritis of the Shoulder (WOOS) outcome measure. [Time frame: 10 years]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Other

Study locations

United States · 1 center
  • Cedars Sinai Medical Center — Los Angeles
Denmark · 1 center
  • Aalborg University Hospital — Aalborg

Identifiers

NCT: NCT06788717 · MDRG2017-89MS-50E

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗