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
Trial website
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
[email protected]
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT04984291