SMR Stemless Reverse Vs SMR Reverse Shoulder System
A Randomized, Multi-Center, Prospective, Safety and Efficacy Study Comparing the Outcome of Total Reverse Shoulder Arthroplasty (RSA) with SMR Stemless Reverse Vs SMR Reverse Shoulder System
1 other identifier
interventional
200
1 country
11
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, 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Apr 2021
Longer than P75 for not_applicable
11 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 4, 2021
CompletedFirst Posted
Study publicly available on registry
January 6, 2021
CompletedStudy Start
First participant enrolled
April 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 30, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
March 30, 2026
CompletedOctober 2, 2024
October 1, 2023
5 years
January 4, 2021
October 1, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Primary Efficacy Endpoint-Constant Murley Score
The primary efficacy endpoint is to assess successful clinical outcomes by Constant-Murley Score (CMS) adjusted for gender and age at month 24 defined as an increase in CMS of at least 15 points over baseline CMS. The Constant-Murley score (CMS) is a 100-points scale composed of a number of individual parameters. These parameters define the level of pain and the ability to carry out the normal daily activities of the patient. The higher the score, the higher the quality of the function.
24 Months
Primary Safety Endpoint-Absence of revisions, reoperations, and implant loosening.
* Revisions - A revision is a procedure that adjusts, modifies, or removes part of the original implant configuration, with or without replacement of a component. This may include removing a component of a joint implant. * Reoperations - A reoperation is any surgical procedure involving the repaired shoulder that does not include removal, modification, or addition of any components to the investigational device (e.g., drainage of a hematoma at the surgical site). Radiographic: Implant Loosening * A humeral component is considered to be at risk for loosening when a radiolucent line \>2 mm is present in four (4) or more of the eight (8) zones or if there is conclusive evidence of migration or tilt of the component. * A glenoid component is considered to be at risk for loosening in case of conclusive evidence of a migration or tilt of the component or in presence of a circumferential radiolucent line of at least 2 mm around the glenoid component.
24 Months
Secondary Outcomes (9)
Secondary Efficacy Measure-Constant-Murley Score
3, 6, and 12 month visits
Secondary Efficacy Measure-American Shoulder and Elbow Surgeons Shoulder Score (ASES)
3, 6, 12 and 24 month visits
Secondary Efficacy Measure-Simple Shoulder Test (SST)
3, 6, 12 and 24 month visits
Secondary Efficacy Measure-EQ-5D-5L
3, 6, 12 and 24 month visits
Secondary Efficacy Measure-Range of Motion (ROM)
3, 6, 12 and 24 month visits
- +4 more secondary outcomes
Study Arms (2)
SMR Stemless Reverse
EXPERIMENTALSMR Reverse Shoulder System
ACTIVE COMPARATORInterventions
The SMR Stemless Reverse is intended for total, primary shoulder joint replacement by reducing pain and restoring shoulder articular mobility function.
Conventional stemmed shoulder prostheses are commonly used in the clinical practice.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Limacorporate S.p.alead
- NAMSAcollaborator
Study Sites (11)
Cedars-Sinai Kerlan-Jobe Institute
Los Angeles, California, 90045, United States
Western Orthopaedics
Denver, Colorado, 80218, United States
Levy Shoulder Center
Boca Raton, Florida, 33428, United States
AdventHealth
Orlando, Florida, 32803, United States
Rush Orthopaedics
Chicago, Illinois, 60612, United States
Upstate Orthopedics
East Syracuse, New York, 13057, United States
Duke University
Durham, North Carolina, 27708, United States
University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
Rothman Orthopaedic
Philadelphia, Pennsylvania, 19107, United States
Guthrie
Sayre, Pennsylvania, 18840, United States
University of Texas- Health Science Center
San Antonio, Texas, 78229, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Grant Garrigues, M.D.
Rush Orthopedics
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 4, 2021
First Posted
January 6, 2021
Study Start
April 1, 2021
Primary Completion
March 30, 2026
Study Completion
March 30, 2026
Last Updated
October 2, 2024
Record last verified: 2023-10
Data Sharing
- IPD Sharing
- Will not share