A Trial to Assess the Safety and Effectiveness of an Anatomic Total Shoulder System
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age22+
SponsorMedacta USA
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Mirror Anatomic Total Shoulder Prosthesis
DeviceTotal 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.
Medacta Anatomic Shoulder
DeviceTotal 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.
Treatment groups
286 Participants
are divided into 2 treatment groupsGroup A: 143 undergoing implantation of the Mirror Anatomic Shoulder Prosthesis (investigational)Experimental treatment 1 intervention
Group B: 143 patients undergoing implantation of Medacta Anatomic Shoulder (control)Active comparator 1 intervention
Trial outcomes
Primary outcomes
1
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
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.
Time frame
24 months of follow upSecondary outcomes
1
Secondary objectives include the assessment of shoulder-specific function and overall health-related quality of life over time using validated patient-reported outcome measures.
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.
Time frame
24 Months of follow upSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: