SMR Stemless Reverse Vs SMR Reverse Shoulder System

Description

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.

Conditions

Arthroplasty, Replacement

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Study Overview

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Study Details

Study overview

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.

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

SMR Stemless Reverse Vs SMR Reverse Shoulder System

Condition
Arthroplasty, Replacement
Intervention / Treatment

-

Contacts and Locations

Los Angeles

Cedars-Sinai Kerlan-Jobe Institute, Los Angeles, California, United States, 90045

Denver

Western Orthopaedics, Denver, Colorado, United States, 80218

Boca Raton

Levy Shoulder Center, Boca Raton, Florida, United States, 33428

Orlando

AdventHealth, Orlando, Florida, United States, 32803

Chicago

Rush Orthopaedics, Chicago, Illinois, United States, 60612

East Syracuse

Upstate Orthopedics, East Syracuse, New York, United States, 13057

Durham

Duke University, Durham, North Carolina, United States, 27708

Philadelphia

University of Pennsylvania, Philadelphia, Pennsylvania, United States, 19104

Philadelphia

Rothman Orthopaedic, Philadelphia, Pennsylvania, United States, 19107

Sayre

Guthrie, Sayre, Pennsylvania, United States, 18840

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • 1. Age ≥ 22 years of age
  • 2. Skeletally mature as evident by scapula and proximal humerus closure
  • 3. 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:
  • 1. Arthritis with rotator cuff tear not reparable
  • 2. Irreparable rotator cuff tear
  • 3. Rotator cuff tear arthropathy
  • 4. Severe osteoarthritis and rotator cuff deficiency or stiff shoulder
  • 5. Significant glenoid or socket side bone deformed or loss
  • 6. Reoccurrence of instability or a chronic shoulder dislocation
  • 7. Any other medical reason that the investigator determine that subject is a good candidate for a reverse total shoulder arthroplasty
  • 1. BMI \> 40 kg/m2
  • 2. Previous contralateral shoulder surgery within 3 months of enrollment or that requires active treatment (i.e. surgery or brace)
  • 3. Had surgery in the targeted shoulder within last 12 months of enrollment, except diagnostic arthroscopy without procedures
  • 4. Had surgery in lower limbs (such as hip or knee) within last 6 months of enrollment
  • 5. Corticosteroid injections in the ipsilateral shoulder within 3 months of enrollment
  • 6. Complete deltoid muscle insufficiency
  • 7. Glenoid retroversion great than 25 degrees based off a 2D axial CT scan
  • 8. History of/or signs and/or symptoms of local or systemic infection including but not limited to septicemia; osteomyelitis
  • 9. Neurologically confirmed nerve lesion compromising shoulder joint function
  • 10. Poor meta-epiphyseal bone stock compromising stability of the implant including but not limited to humeral head fracture, iatrogenic glenoid fracture, severe osteoporosis
  • 11. Metabolic disorders which may impair fixation and stability of the implant including but not limited to uncontrolled diabetes mellitus with an HbA1C \> 7.5%
  • 12. Extended bone loss after previous surgery defined as: complete bone loss of greater and lesser tuberosity
  • 13. Meta-epiphyseal bony defect (including large cyst)

Ages Eligible for Study

22 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Limacorporate S.p.a,

Grant Garrigues, M.D., PRINCIPAL_INVESTIGATOR, Rush Orthopedics

Study Record Dates

2026-03-30