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Post-Market Study of Comprehensive Reverse Augmented Glenoid and Mini Humeral Tray in Total Shoulder Arthroplasty

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03726554
Recruitment Status : Recruiting
First Posted : October 31, 2018
Last Update Posted : October 21, 2019
Sponsor:
Information provided by (Responsible Party):
Zimmer Biomet

Brief Summary:
This study is a multicenter, prospective, non-randomized, non-controlled, dual cohort post market surveillance study. The primary objective of this study is to confirm the safety and performance of the Comprehensive Reverse Shoulder System when used with the Comprehensive Porous Augmented Glenoid Baseplate and/or Comprehensive Mini Humeral Tray in primary and revision reverse shoulder arthroplasty.

Condition or disease Intervention/treatment
Arthropathy of Shoulder Region Grossly Deficient Rotator Cuff Osteoarthritis of the Shoulder Rheumatoid Arthritis Without Humeral Metaphyseal Defects Post-Traumatic Arthritis Device: Comprehensive Reverse Porous Augmented Glenoid Device: Comprehensive Mini Humeral Tray

Detailed Description:

The Comprehensive Reverse Porous Augmented Glenoid Baseplate and Comprehensive Mini Humeral Tray belong to the Comprehensive Reverse Shoulder Arthroplasty System. They were developed to provide patients with grossly deficient rotator cuffs with another surgical option. The aim of the Comprehensive Reverse Shoulder System is to increase shoulder function while reducing pain.

A maximum of 7 sites will contribute to this study. Enrollment of 7 sites on a global scale will allow for assessment of device consistency across different regions. Enrollment per site will not exceed 45 shoulders. 146 implants will be included in this study with competitive enrollment. All potential study subjects will be required to participate in the Informed Consent process.

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Study Type : Observational
Estimated Enrollment : 146 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Comprehensive Reverse Shoulder: Porous Augmented Glenoid Baseplate and Mini Humeral Tray Post-Market Clinical Follow-up Study
Actual Study Start Date : August 28, 2018
Estimated Primary Completion Date : February 2030
Estimated Study Completion Date : February 2030

Group/Cohort Intervention/treatment
Comp. Rev. Porous Augmented Glenoid
Subjects with a grossly deficient rotator cuff in need of a reverse shoulder arthroplasty who met the inclusion/exclusion criteria and received the Comprehensive Reverse Porous Augmented Glenoid.
Device: Comprehensive Reverse Porous Augmented Glenoid
Three glenoid baseplate options designed for various severities of glenoid erosion and deformity, the device promotes bony ingrowth while restoring natural human anatomy.

Comp. Rev. Mini Humeral Tray
Subjects with a grossly deficient rotator cuff in need of a reverse shoulder arthroplasty who met the inclusion/exclusion criteria and received the Comprehensive Reverse Mini Humeral Tray
Device: Comprehensive Mini Humeral Tray
The mini humeral tray offers additional sizing options to the Comprehensive Shoulder line. The mini tray is designed to fit smaller anatomies.




Primary Outcome Measures :
  1. Implant Survivorship [ Time Frame: 10 years ]
    Based on removal or intended removal of the device and determined using the Kaplan-Meier method


Secondary Outcome Measures :
  1. Frequency and Incidence of Adverse Events [ 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.

  2. Clinical efficacy of the device is assessed using the American Shoulder and Elbow Surgeon Score Patient Questionnaire. [ Time Frame: 10 years ]
    Pain, function, and activities of daily living are measured. The ASES scale is 0-100. 100 is the highest score and indicates the greatest function while 0 is the lowest score.

  3. Radiographic Performance [ Time Frame: 10 years ]
    X-rays will be evaluated for radiolucency, osteolysis, atrophy, hypertrophy, osteophytes, component migration, scapular notching and heterotopic ossification



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients in need of a reverse shoulder arthroplasty who receive a Comprehensive Reverse Porous Augmented Glenoid and/or Comprehensive Mini Humeral Tray who meet all of the inclusion and none of the exclusion criteria.
Criteria

Inclusion Criteria:

  • Patient must be 18 years of age or older.
  • Patient must be anatomically and structurally suited to receive the implants and possess a functional deltoid.
  • Patient must have a grossly deficient rotator cuff with severe arthropathy and/or a previously failed shoulder joint replacement with a grossly deficient rotator cuff.
  • Patient must be able and willing to complete the protocol required follow-up.
  • Patient must be able and willing to sign the Institutional Review Board/Ethics Committee approved informed consent.

Exclusion Criteria:

  • Patient is a prisoner.
  • Patient is a current alcohol or drug abuser.
  • Uncooperative patient or patient with neurologic disorders who is incapable or unwilling to follow directions.
  • Patient presents with osteoporosis.
  • Patient has a metabolic disorder that may impair bone formation.
  • Patient has osteomalacia.
  • Patient has distant foci of infections which may spread to the implant site.
  • Patient has rapid joint destruction, marked bone loss or bone resorption apparent on roentgenogram.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03726554


Contacts
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Contact: Robert Barnhill 574-377-9104 robert.barnhill@zimmerbiomet.com

Locations
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United States, Kentucky
Norton Orthopedic Specialists Recruiting
Louisville, Kentucky, United States, 40241
Contact: Barbara Patterson    502-333-2610    barbara.patterson@nortonhealthcare.org   
United States, Virginia
The Rector and Visitors of the University of Virginia Recruiting
Charlottesville, Virginia, United States, 22903
Contact: Kaitlyn Shank    434-243-5653    kcg4hf@hscmail.mcc.virginia.edu   
Sponsors and Collaborators
Zimmer Biomet
Investigators
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Study Director: William Bourdeau Director, Global Clinical Operations

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Responsible Party: Zimmer Biomet
ClinicalTrials.gov Identifier: NCT03726554    
Other Study ID Numbers: CMG2017-70E
First Posted: October 31, 2018    Key Record Dates
Last Update Posted: October 21, 2019
Last Verified: October 2019

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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.: Yes
Keywords provided by Zimmer Biomet:
Reverse Shoulder Arthroplasty
Medical Device
Performance
Safety
Shoulder Prosthesis
Glenoid Erosion
Additional relevant MeSH terms:
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Arthritis
Joint Diseases
Musculoskeletal Diseases