Status:
RECRUITING
SMR Stemless Reverse Vs SMR Reverse Shoulder System
Lead Sponsor:
Limacorporate S.p.a
Collaborating Sponsors:
NAMSA
Conditions:
Arthroplasty, Replacement
Eligibility:
All Genders
22+ years
Phase:
NA
Brief 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,...
Eligibility Criteria
Inclusion
- 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
- Reoccurrence of instability or a chronic shoulder dislocation
- Any other medical reason that the investigator determine that subject is a good candidate for a reverse total shoulder arthroplasty
Exclusion
- BMI \> 40 kg/m2
- Previous contralateral shoulder surgery within 3 months of enrollment or that requires active treatment (i.e. surgery or brace)
- Had surgery in the targeted shoulder within last 12 months of enrollment, except diagnostic arthroscopy without procedures
- Had surgery in lower limbs (such as hip or knee) within last 6 months of enrollment
- Corticosteroid injections in the ipsilateral shoulder within 3 months of enrollment
- Complete deltoid muscle insufficiency
- Glenoid retroversion great than 25 degrees based off a 2D axial CT scan
- History of/or signs and/or symptoms of local or systemic infection including but not limited to septicemia; osteomyelitis
- Neurologically confirmed nerve lesion compromising shoulder joint function
- Poor meta-epiphyseal bone stock compromising stability of the implant including but not limited to humeral head fracture, iatrogenic glenoid fracture, severe osteoporosis
- Metabolic disorders which may impair fixation and stability of the implant including but not limited to uncontrolled diabetes mellitus with an HbA1C \> 7.5%
- Extended bone loss after previous surgery defined as: complete bone loss of greater and lesser tuberosity
- Meta-epiphyseal bony defect (including large cyst)
Key Trial Info
Start Date :
April 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 30 2026
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT04697004
Start Date
April 1 2021
End Date
March 30 2026
Last Update
October 2 2024
Active Locations (11)
Enter a location and click search to find clinical trials sorted by distance.
1
Cedars-Sinai Kerlan-Jobe Institute
Los Angeles, California, United States, 90045
2
Western Orthopaedics
Denver, Colorado, United States, 80218
3
Levy Shoulder Center
Boca Raton, Florida, United States, 33428
4
AdventHealth
Orlando, Florida, United States, 32803