Zimmer Biomet Shoulder Arthroplasty PMCF

Shoulder Pain Clinical Trial

Official title:

Zimmer Biomet Shoulder Arthroplasty Long-term Post Market Clinical Follow-up Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04984291
• Other study ID #: CMU2019-35E
• Status: Recruiting
• Phase: N/A
• Start date: July 28, 2021
• Est. completion date: August 15, 2033

Study information

• Verified date: May 2024
• Source: Zimmer Biomet
• Contact: Jeff Schram, MS
• Phone: 574-371-9786
• Email: jeffrey.schram[@]zimmerbiomet.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 584
• Est. completion date: August 15, 2033
• Est. primary completion date: August 15, 2033
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Shoulder Arthritis
• Shoulder Fractures
• Shoulder Injuries
• Shoulder Osteoarthritis
• Shoulder Pain

Intervention

Device:
• Alliance Glenoid
Alliance Glenoid used in Primary or Revision Total Shoulder Arthroplasty
• 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

Locations

Country	Name	City	State
Japan	Fukui General Hospital	Fukui
Japan	Iwaki City Medical Center	Fukushima
Japan	Yuuai Medical Center	Okinawa
Japan	Kichijoji Minami Hospital	Tokyo
New Zealand	Kensington Private Hospital	Whangarei
United States	TRIA Orthopaedic Center Research Institute	Bloomington	Minnesota
United States	University of Buffalo	Buffalo	New York
United States	Northwestern University	Chicago	Illinois
United States	Panorama Orthopaedic and Spine Center	Golden	Colorado
United States	Hoag Orthopedic Institute	Irvine	California
United States	Mississippi Sports Medicine and Orthopaedic Center, PLLC	Jackson	Mississippi
United States	Norton Healthcare, Inc	Louisville	Kentucky
United States	Intermountain Health	Murray	Utah
United States	Rothman Institute	Philadelphia	Pennsylvania
United States	William Beaumont Hospital	Royal Oak	Michigan
United States	Washington University	Saint Louis	Missouri
United States	Advance Bone and Joint	Saint Peters	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Zimmer Biomet

Countries where clinical trial is conducted

United States,  Japan,  New Zealand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Implant Survivorship at 10 years follow-up (Kaplan Meier)	Based on removal or intended removal of the device and determined using the Kaplan-Meier method.	10 years
Primary	Frequency and Incidence of Adverse Events (Safety)	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.	10 years
Secondary	Clinical efficacy of the device is assessed using the American Shoulder and Elbow Surgeons (ASES) Shoulder Score at 2 years follow-up	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.	2 years
Secondary	Euroqol Patient Quality of life measured at 2 years follow-up (EQ-5D-5L)	The EuroQol five dimensions questionnaire (EQ-5D-5L) is a five dimensional self-assessment that is comprised of mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. These five dimensions can be used to index a subject's health utility on a scale of 0 to 1, where 0 is death and 1 is perfect health. The scoring rule for EQ-5D permits scores less than 0, implying that some health states may be worse than death.	2 years
Secondary	Radiographic Performance [Radiolucency] at 2 years follow-up	X-rays will be evaluated for radiolucency lines to show the number of subjects with radiolucency. Radiolucency refers to structures that are less dense and permit the x-ray beam to pass through them. Radiolucent structures appear dark or black in the radiographic image.	2 years
Secondary	Radiographic Performance [Osteolysis] at 2 years follow-up	X-rays will be evaluated for osteolysis to show the number of subjects with osteolysis. Osteolysis is a progressive condition where bone tissue is destroyed. In this process, bones lose minerals (mostly calcium), softens, degenerates and become weaker.	2 years
Secondary	Radiographic Performance [Heterotopic Ossification] at 2 years follow-up	X-rays will be evaluated for heterotopic ossification to show the number of subjects with heterotopic ossification. Heterotopic ossification refers to the presence of bone in soft tissue where bone normally does not exist (extraskeletal bone).	2 years
Secondary	Radiographic Performance [Humeral Component Subsidence] at 2 years follow-up	X-rays will be evaluated for humeral component subsidence to show the number of subjects with subsidence. Component Subsidence refers to the presence of the device component gradually sinking or caving into the bone structure.	2 year
Secondary	Radiographic Performance [Glenoid Component Migration] at 2 years follow-up	X-rays will be evaluated for glenoid component migration to show the number of subjects with migration. Component migration refers to the presence of the device component gradually moving anteriorly, posteriorly, superiorly, or inferiorly in relation to original placement.	2 year