Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04984291




Registration number
NCT04984291
Ethics application status
Date submitted
16/07/2021
Date registered
30/07/2021
Date last updated
28/06/2024

Titles & IDs
Public title
Zimmer Biomet Shoulder Arthroplasty PMCF
Scientific title
Zimmer Biomet Shoulder Arthroplasty Long-term Post Market Clinical Follow-up Study
Secondary ID [1] 0 0
CMU2019-35E
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Shoulder Fractures 0 0
Shoulder Arthritis 0 0
Shoulder Osteoarthritis 0 0
Shoulder Deformity 0 0
Shoulder Injuries 0 0
Shoulder Pain 0 0
Condition category
Condition code
Neurological 0 0 0 0
Other neurological disorders
Injuries and Accidents 0 0 0 0
Other injuries and accidents
Musculoskeletal 0 0 0 0
Other muscular and skeletal disorders
Injuries and Accidents 0 0 0 0
Fractures

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - Alliance Glenoid
Treatment: Devices - Identity Stem

Experimental: Zimmer Biomet Total Shoulder Arthroplasty System - Patients who are having primary or revision total shoulder arthroplasty who will receive a Zimmer Biomet Total Shoulder Arthroplasty System.


Treatment: Devices: Alliance Glenoid
Alliance Glenoid used in Primary or Revision Total Shoulder Arthroplasty

Treatment: Devices: Identity Stem
Identity Shoulder System is intended to be used in anatomic total shoulder arthroplasty, shoulder hemi-arthroplasty, or total reverse shoulder arthroplasty in both Primary or Revision Total Shoulder Arthroplasty
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Implant Survivorship at 10 years follow-up (Kaplan Meier)
Timepoint [1] 0 0
10 years
Primary outcome [2] 0 0
Frequency and Incidence of Adverse Events (Safety)
Timepoint [2] 0 0
10 years
Secondary outcome [1] 0 0
Clinical efficacy of the device is assessed using the American Shoulder and Elbow Surgeons (ASES) Shoulder Score at 2 years follow-up
Timepoint [1] 0 0
2 years
Secondary outcome [2] 0 0
Euroqol Patient Quality of life measured at 2 years follow-up (EQ-5D-5L)
Timepoint [2] 0 0
2 years
Secondary outcome [3] 0 0
Radiographic Performance [Radiolucency] at 2 years follow-up
Timepoint [3] 0 0
2 years
Secondary outcome [4] 0 0
Radiographic Performance [Osteolysis] at 2 years follow-up
Timepoint [4] 0 0
2 years
Secondary outcome [5] 0 0
Radiographic Performance [Heterotopic Ossification] at 2 years follow-up
Timepoint [5] 0 0
2 years
Secondary outcome [6] 0 0
Radiographic Performance [Humeral Component Subsidence] at 2 years follow-up
Timepoint [6] 0 0
2 year
Secondary outcome [7] 0 0
Radiographic Performance [Glenoid Component Migration] at 2 years follow-up
Timepoint [7] 0 0
2 year

Eligibility
Key inclusion criteria
* Patient must be 20 years of age or older.
* Patient must be anatomically and structurally suited to receive shoulder arthroplasty implants.
* Patient is a candidate for shoulder arthroplasty due to one or more of the following:

* Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis.
* Rheumatoid arthritis.
* Correction of functional deformity.
* Fractures of the proximal humerus, where other methods of treatment are deemed inadequate.
* Difficult clinical management problems, where other methods of treatment may not be suitable or may be inadequate.
* Patient must be able and willing to complete the protocol required follow-up.
* Patient must be able and willing to sign the IRB/EC approved informed consent.
* Patient has grossly deficient rotator, (for reverse application)

* With severe arthropathy and/or
* Previously failed shoulder joint replacement
* Patient must have functional deltoid muscle (for reverse application)
Minimum age
20 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Patient is unwilling or unable to give consent or to comply with the follow-up program.
* Patient has any condition which would in the judgement of the Investigator, place the patient at undue risk or interfere with the study.
* Patient is known to be pregnant or breastfeeding.
* Patient is a vulnerable subject (prisoner, mentally incompetent or unable to understand what participation to the study entails, a known alcohol or drug abuser, and/or anticipated to be non-compliant).
* Patient is uncooperative or patient with neurologic disorders who is incapable or unwilling to follow directions.
* Patient has any sign of infection affecting the shoulder joint or in its proximity which may spread to the implant site.
* Patient has rapid joint destruction, marked bone loss, or bone resorption apparent on roentgenogram.
* Patient has any neuromuscular disease compromising the affected limb that would render the procedure unjustifiable.
* Patient presents with osteoporosis, which in the opinion of the Investigator, may limit the subject's ability to support total shoulder arthroplasty using the study device.
* Patient has osteomalacia.
* Patient has a metabolic disorder that may impair bone formation.
* Patient has deficient rotator cuff.
* Patient presents with significant injury to the upper brachial plexus.
* Patient has paralysis of the axillary nerve.
* Patient has non-functional deltoid or external rotator muscles.

Study design
Purpose of the study
Treatment
Allocation to intervention
NA
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
NA
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
28/07/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
15/08/2033
Actual
Sample size
Target
584
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Colorado
Country [3] 0 0
United States of America
State/province [3] 0 0
Illinois
Country [4] 0 0
United States of America
State/province [4] 0 0
Kentucky
Country [5] 0 0
United States of America
State/province [5] 0 0
Michigan
Country [6] 0 0
United States of America
State/province [6] 0 0
Minnesota
Country [7] 0 0
United States of America
State/province [7] 0 0
Mississippi
Country [8] 0 0
United States of America
State/province [8] 0 0
Missouri
Country [9] 0 0
United States of America
State/province [9] 0 0
New York
Country [10] 0 0
United States of America
State/province [10] 0 0
Pennsylvania
Country [11] 0 0
United States of America
State/province [11] 0 0
Utah
Country [12] 0 0
Japan
State/province [12] 0 0
Fukui
Country [13] 0 0
Japan
State/province [13] 0 0
Fukushima
Country [14] 0 0
Japan
State/province [14] 0 0
Okinawa
Country [15] 0 0
Japan
State/province [15] 0 0
Tokyo
Country [16] 0 0
New Zealand
State/province [16] 0 0
Whangarei

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Zimmer Biomet
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The objectives of this study are to confirm the safety, performance, and clinical benefits of Zimmer Biomet Shoulder Arthroplasty Systems and its instrumentation in primary or revision shoulder arthroplasty. These objectives will be assessed using standard scoring systems, radiographic evidence, and adverse event records. Safety of the system will be assessed by monitoring the frequency an incidence of adverse events.
Trial website
https://clinicaltrials.gov/study/NCT04984291
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Ryan Boylan
Address 0 0
Zimmer Biomet
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Jeff Schram, MS
Address 0 0
Country 0 0
Phone 0 0
574-371-9786
Fax 0 0
Email 0 0
jeffrey.schram@zimmerbiomet.com
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT04984291