Clinical trial NCT04984291: Zimmer Biomet Shoulder Arthroplasty PMCF
Official title: Zimmer Biomet Shoulder Arthroplasty Long-term Post Market Clinical Follow-up Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Shoulder Fractures
Shoulder Arthritis
Shoulder Osteoarthritis
Shoulder Deformity
Shoulder Injuries
Shoulder Pain
Keywords: Total Shoulder Arthroplasty
Glenoid
Humeral Stem
Stem Adapter
Humeral Head
Humeral Bearing
Humeral Trays
Head Adapter
Reverse
Anatomic
Hemi
Lead sponsor: Zimmer Biomet
Sponsor class: INDUSTRY
First posted: 2021-07-30
Enrollment: 584
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Detailed description: The primary endpoint is defined as survival of the implant at 10 years, which is based on removal or intended removal of at least 1-study implant component and will be determined by using the Kaplan Meier method. The safety of the system will be assessed by monitoring the frequency and incidence of adverse events. Separate analysis will be done for each arm of the study.

The secondary endpoint is represented by the performance and clinical benefits of Zimmer Biomet Shoulder Arthroplasty Systems and its instrumentation after 2 years, which will be assessed by the American Shoulder and Elbow Surgeons (ASES) shoulder score. The secondary endpoint evaluation will also assess the overall pain, functional performance, quality of life and radiographic parameters of all enrolled study subjects.

Eligibility criteria: 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)

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.

Primary outcomes:
measure: Implant Survivorship at 10 years follow-up (Kaplan Meier)
timeFrame: 10 years
measure: Frequency and Incidence of Adverse Events (Safety)
timeFrame: 10 years
Secondary outcomes:
measure: Clinical efficacy of the device is assessed using the American Shoulder and Elbow Surgeons (ASES) Shoulder Score at 2 years follow-up
timeFrame: 2 years
measure: Euroqol Patient Quality of life measured at 2 years follow-up (EQ-5D-5L)
timeFrame: 2 years
measure: Radiographic Performance [Radiolucency] at 2 years follow-up
timeFrame: 2 years
measure: Radiographic Performance [Osteolysis] at 2 years follow-up
timeFrame: 2 years
measure: Radiographic Performance [Heterotopic Ossification] at 2 years follow-up
timeFrame: 2 years
measure: Radiographic Performance [Humeral Component Subsidence] at 2 years follow-up
timeFrame: 2 year
measure: Radiographic Performance [Glenoid Component Migration] at 2 years follow-up
timeFrame: 2 year
Other outcomes:
Locations:
city: Irvine
country: United States
facility: Hoag Orthopedic Institute
state: California
city: Golden
country: United States
facility: Panorama Orthopaedic and Spine Center
state: Colorado
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
city: Louisville
country: United States
facility: Norton Healthcare, Inc
state: Kentucky
city: Royal Oak
country: United States
facility: William Beaumont Hospital
state: Michigan
city: Bloomington
country: United States
facility: TRIA Orthopaedic Center Research Institute
state: Minnesota
city: Jackson
country: United States
facility: Mississippi Sports Medicine and Orthopaedic Center, PLLC
state: Mississippi
city: Saint Louis
country: United States
facility: Washington University
state: Missouri
city: Saint Peters
country: United States
facility: Advance Bone and Joint
state: Missouri
city: Buffalo
country: United States
facility: University of Buffalo
state: New York
city: Philadelphia
country: United States
facility: Rothman Institute
state: Pennsylvania
city: Murray
country: United States
facility: Intermountain Health
state: Utah
city: Fukui
country: Japan
facility: Fukui General Hospital
city: Fukushima
country: Japan
facility: Iwaki City Medical Center
city: Okinawa
country: Japan
facility: Yuuai Medical Center
city: Tokyo
country: Japan
facility: Kichijoji Minami Hospital
city: Whangarei
country: New Zealand
facility: Kensington Private Hospital
Study officials:
affiliation: Zimmer Biomet
name: Ryan Boylan
role: STUDY_DIRECTOR
References: