SMR Stemless Reverse Vs SMR Reverse Shoulder System (NCT04697004) | Clinical Trial Compass
UnknownNot Applicable
SMR Stemless Reverse Vs SMR Reverse Shoulder System
United States200 participantsStarted 2021-04-01
Plain-language summary
The SMR Stemless Reverse is intended for total, primary shoulder joint replacement by reducing pain and restoring shoulder articular mobility function. This is a prospective, multi-center, randomized, controlled trial to demonstrate non-inferiority of the SMR Stemless Reverse to the SMR Reverse Shoulder System.
Patients with joint dysfunction who continue to experience significant symptoms despite an appropriate course of non-operative management are eligible. Patients will be considered enrolled into the study when an ICF has been signed, all inclusion criteria are met and no exclusion criteria are present including intraoperative exclusion criteria, and the patient is randomized into either the SMR Stemless Reverse (investigational) group, the SMR Reverse Shoulder System (control) group or is part of the roll-in population. Enrollment is expected to take approximately 24 months.
Who can participate
Age range22 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Age ≥ 22 years of age
✓. Skeletally mature as evident by scapula and proximal humerus closure
✓. Candidate for primary total shoulder replacement in a grossly rotator cuff deficient joint with severe arthropathy (disabled shoulder), when clinical indications based on physical exam and medical history including one or more of the following:
✓. Arthritis with rotator cuff tear not reparable
✓. Irreparable rotator cuff tear
✓. Rotator cuff tear arthropathy
✓. Severe osteoarthritis and rotator cuff deficiency or stiff shoulder
✓. Significant glenoid or socket side bone deformed or loss
Exclusion criteria
✕. BMI \> 40 kg/m2
✕. Previous contralateral shoulder surgery within 3 months of enrollment or that requires active treatment (i.e. surgery or brace)
What they're measuring
1
Primary Efficacy Endpoint-Constant Murley Score
Timeframe: 24 Months
2
Primary Safety Endpoint-Absence of revisions, reoperations, and implant loosening.