Overview
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.
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
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