Clinical trial NCT05868148: Shoulder iD™ Primary Reversed Glenoid Outcomes Clinical Study
Official title: Shoulder iD™ Primary Reversed Glenoid Outcomes Clinical Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Rotator Cuff Tears
Rheumatoid Arthritis Shoulder
Osteoarthritis Shoulder
Avascular Necrosis of the Head of Humerus
Fracture, Humeral
Traumatic Arthritis of Right Shoulder Region (Diagnosis)
Shoulder Deformity
Keywords: Massive RCT
Non-repairable RCT
Glenohumeral joint
Lead sponsor: Stryker Trauma and Extremities
Sponsor class: INDUSTRY
First posted: 2023-05-22
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The intended patient population are adult patients who have reached skeletal maturity, with a functional deltoid muscle, and massive and non-repairable rotator cuff tear within one or more indications and zero contraindications with pain disabled by:

* Rheumatoid arthritis
* Non-inflammatory degenerative joint disease (i.e. osteoarthritis and avascular necrosis)
* Correction of functional deformity
* Fractures of the humeral head
* Traumatic arthritis
* Revision of glenohumeral joint if sufficient native glenoid bone remains

Brief summary: The goal of the Shoulder iD™ Primary Reversed Glenoid Outcomes Clinical Study is to collect safety and performance data on the commercially available Shoulder iD™ Primary Reversed Glenoid device. The study will learn about standard device use in adult patients who have a functional deltoid muscle and massive and non-repairable rotator cuff tear. The main questions it aims to answer are:

* What is the average improvement in patient-reported shoulder function after 2 years when compared to before the surgery, and
* What is the rate of surgical revisions needed over a 10 year period

Patients will be asked to will be asked to regularly attend their check-up visits with their surgeon (including having x-rays or CT images taken to check their shoulder and implant), to complete questionnaires to report how their shoulder is doing, and to tell their surgeon when they notice any changes.

Detailed description: The Shoulder iD™ Primary Reversed Glenoid Outcomes Clinical Study is a Global, single arm, multicenter, prospective, non-significant risk Post-Market Clinical Follow-up (PMCF) study, designed to collect safety and performance data on designated commercially available Shoulder iD™ Primary Reversed Glenoid.

The objective of this multicenter study is to collect clinical data at baseline, surgery, immediate post-op, and annually through 10 years post-operation, on related clinical complications and clinical outcomes of market-approved Shoulder iD™ Primary Reversed Glenoid, to demonstrate safety and performance of these implants in a real-world setting.

The primary outcome measure is the average improvement in American Shoulder and Elbow Surgeons (ASES) score from baseline to 24 months.

Secondary outcome measures include the following assessments to be evaluated throughout the patient's participation in the study:

* Constant Score (years 1, 2, 5 and 10 only)
* Single Assessment Numeric Evaluation (SANE) Score
* Patient Satisfaction
* EQ-5D-5L

Radiologic imaging: Patient images (X-ray or CT) completed at baseline and in-person follow-ups will be analyzed for standard radiographic findings, including, but not limited to: device migration, component breakage, radiolucencies and bone characteristics.

Revision rate and survivorship will be assessed annually and at any time upon request for regulatory purposes such as PMCF or Clinical Evaluation Report (CER) updates. The cumulative incidence of device revisions and reoperations will be reported as well as Kaplan-Meier estimates for implant survival.

Adverse events will be evaluated from inclusion to last follow-up and will be documented during the study and categorized as whether they are serious and whether they are related to the Sponsor device or implant procedure.

During the study, patients will undergo the following procedures, which are standard of care:

* Patient information and Consent (as applicable per local regulation),
* Inclusion/non-inclusion criteria,
* Demography, Height \& Weight,
* Surgical history and relevant medical history,
* Physician exams (Range of Motion and Strength measurements),
* Patient questionnaires (ASES, Constant, SANE, Patient Satisfaction, EQ-5D-5L),
* Shoulder study implant \& surgery related data,
* CT scans, x-rays
* AE / SAE collection (continuous recording).

Eligibility criteria: Inclusion Criteria:

* 18 years or older at the time of the informed consent or non-opposition (when applicable).
* Informed and willing to sign an informed consent form approved by IRB or EC (when applicable).
* Willing and able to comply with the requirements of the study protocol.
* Considered a candidate for shoulder arthroplasty using a study device.
* Meets indications for use requirements or other local, regional, or geographic specific regulatory requirements

Exclusion Criteria:

* Patients who are not able to comply with the study procedures based on the judgment of the assessor (e.g., cannot comprehend study questions, inability to keep scheduled assessment times).
* Patient belongs to a vulnerable group of patients, including minor patients, those unable to decide for themselves to participate or needing a Legally Authorized Representative (LAR), or others who could be subject to coercion (patients who may not be acting on their own initiative) (referred to as a "vulnerable subject" in section 3.44 of the ISO 14155:2020).
* Active local or systemic infection, sepsis, or osteomyelitis
* Poor bone quality, where there could be considerable migration of the prothesis and/or a chance of fracture of the humerus or glenoid (reassessed at time of surgery)
* Significant injury to the brachial plexus
* Inadequate bone stock in the proximal humerus or glenoid fossa for supporting the device components
* Neuromuscular disease (e.g., joint neuropathy) Known allergy to one of the product materials
* Metabolic disorders which may impair bone formation

Primary outcomes:
measure: Performance: change in functional ability of the treated shoulder
timeFrame: from baseline to 24 months
measure: Safety: Revision rate and device survivorship
timeFrame: from date of inclusion until date of study exit (study completion or early termination for any cause), assessed up to 10 years
Secondary outcomes:
measure: Performance: change in level of pain and ability to carry out normal daily activities of the patient
timeFrame: from date of inclusion until date of study exit (study completion or early termination for any cause), assessed up to 10 years
measure: Performance: change in patient self-assessment of current status of their treated shoulder
timeFrame: from date of inclusion until date of study exit (study completion or early termination for any cause), assessed up to 10 years
measure: Performance: change in patient self-rated quality of life
timeFrame: from date of inclusion until date of study exit (study completion or early termination for any cause), assessed up to 10 years
measure: Performance: change in patient satisfaction with their shoulder
timeFrame: from date of inclusion until date of study exit (study completion or early termination for any cause), assessed up to 10 years
measure: Safety: Adverse Event rate and assessments
timeFrame: from date of treatment until date of study exit (study completion or early termination for any cause), assessed up to 10 years
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: UCSF
state: California
city: Bradenton
country: United States
facility: Coastal Orthopedics
state: Florida
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Columbus
country: United States
facility: Jameson Crane Sports Medicine Institute OSU
state: Ohio
city: Frisco
country: United States
facility: UT Southwestern
state: Texas
city: Houston
country: United States
facility: UT Health Science center - Houston
state: Texas
city: Tyler
country: United States
facility: CHRISTUS Mother Frances Research
state: Texas
city: Roanoke
country: United States
facility: Carilion Clinic
state: Virginia
Study officials:
affiliation: Stryker Trauma and Extremities
name: Rebecca Gibson
role: STUDY_DIRECTOR
References: