Shoulder Arthroplasty, Total Shoulder Arthroplasty
Conditions
Brief summary
This study is designed to show that the clinical performance of Mirror Anatomic Shoulder Prosthesis meets the performance of currently marketed device in terms of a composite success endpoint (functional score, radiologic appearance, revisions, adverse events) at 24 months of follow up.
Interventions
DEVICEMirror Anatomic Total Shoulder Prosthesis
Total shoulder arthroplasty is a well-established procedure to treat glenohumeral osteoarthritis (OA), which is usually associated with chronic pain of varying severity, as well as loss of motion and function. To reduce polyethylene wear, a new Shoulder System, mirroring the materials at the humeral/glenoid interface.
DEVICEMedacta Anatomic Shoulder
Total shoulder arthroplasty is a well-established procedure to treat glenohumeral osteoarthritis (OA), which is usually associated with chronic pain of varying severity, as well as loss of motion and function.
Sponsors
Medacta USA
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
22 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adult subject 22 years or older * Clinical indication for total shoulder replacement due to osteoarthritis, and/or post-traumatic arthritis. * Scapula and proximal humerus must have reached skeletal maturity * Willing and able to comply with the protocol * Willing and able to sign the informed consent (or the Legally Authorized Representative will sign for the subject)
Exclusion criteria
* Lack of sufficient bone quality that in the Investigator's medical judgment could compromise implant fixation or bone healing, including conditions such as: * Rapid joint destruction, marked bone loss or bone resorption; * Destruction of the proximal humerus that precludes rigid fixation of the humeral component; and * Osteomalacia * osteoporosis * rheumatoid arthritis * Metal allergies or sensitivity, including a known allergic reaction to implant metals (e.g., nickel) or polyethylene * Patient presents with a malunion or non-union of the tuberosities of the proximal humerus. * Infection at or near the site of implantation, including: * Glenohumeral joint infection * Osteomyelitis * Distant or systemic infection * Medical conditions or balance impairments that could lead to falls * Prior Total, or Reverse Total Shoulder arthroplasty in the affected shoulder. * Prior failed rotator cuff surgery, but excluding successful shoulder arthroscopy * Any full thickness rotator cuff tear at the time of surgery or a nonfunctional rotator cuff * Excessive glenoid bone loss defined by preoperative computed tomography (CT) scans of the shoulder which show insufficient glenoid bone, or insufficient bone identified at the time of surgery * Metabolic disorders which may impair bone function * Nonfunctional deltoid muscle * Neuromuscular compromise condition of the shoulder (e.g., neuropathic joints or brachioplexus injury with a flail shoulder joint) * Patients diagnosed with severe shoulder instability * Patients diagnosed with subscapularis incompetence * Known active metastatic or neoplastic diseases, Paget's disease or Charcot's disease * Currently, or within the last 6 months, or planning to be on chemotherapy or radiation * Currently taking \> 5mg/day corticosteroids (e.g. prednisone) excluding inhalers, within 3 months prior to surgery or patients presenting with symptoms of chronic steroid use. (oral steroids for a chronic condition for 12 months prior to and including the date of surgery) * Female subjects who are pregnant or planning to become pregnant within the study period * In the surgeon's opinion, the subject is unable to understand the study or be compliant with the follow up or have a history of non-compliance with medical advice * History of any cognitive or mental health status that would interfere with study participation * Substance Use Disorder (alcohol and/or drug) * Engages in manual labor or sports activities that could affect shoulder outcome * Patients who have a work-related injury leading to shoulder OA * Currently enrolled in any clinical research study that might interfere with the current study endpoints * Patients with a life expectancy of less than three years * Medical condition or balance impairment that could lead to falls * Weight bearing shoulder due to wheelchair, crutches, rollator at the time of operation * Individuals who are incarcerated or detained in a correctional facility or under any form of legal supervision that limits their ability to voluntarily consent to participate in the trial. * Previous randomization of the subject in the current study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| This study is designed to show that the clinical performance of Mirror Anatomic Shoulder Prosthesis is non-inferior to the performance of currently marketed devices in terms of a composite success endpoint | 24 months of follow up | The primary endpoint is clinical success, that will be determined if the following 4 criteria are met: No device-related serious adverse event have occurred, ASES score improved more than the Minimally Clinical Important Difference and is at least "fair", No radiological signs of implant subsidence, loosening or progressive radiolucency observed in the humeral or glenoid compartment, as defined in the Radiographic Evaluation Protocol, No revisions, removals, reoperations, or supplemental fixations. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Secondary objectives include the assessment of shoulder-specific function and overall health-related quality of life over time using validated patient-reported outcome measures. | 24 Months of follow up | The secondary endpoint at 24 months will be determined at the 6-week, 6-month, and 1-year timepoints. Radiographic evaluation and assessment, a 100-point patient-reported scale used to evaluate shoulder pain and daily function, 12 questions used to measure general physical/mental health from a patient's perspective (This is evaluated 0-100), Implant survival, and Adverse Events. |
Countries
United States
Contacts
CONTACTRena Mandino, CCRP
CONTACTEmily Hord, CCRP
Outcome results
None listed