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NCT04697004 | RECRUITING | Arthroplasty, Replacement

SMR Stemless Reverse Vs SMR Reverse Shoulder System
Sponsor:

Limacorporate S.p.a

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.

Condition or disease

Arthroplasty, Replacement

Intervention/treatment

Investigational Arm: SMR Stemless Reverse

Control Arm: SMR Reverse Shoulder System

Phase

NA

Study Type : INTERVENTIONAL
Estimated Enrollment : 200 participants
Masking : NONE
Primary Purpose : TREATMENT
Official Title : 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
Actual Study Start Date : 2021-04-01
Estimated Primary Completion Date : 2026-03-30
Estimated Study Completion Date : 2026-03-30

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 22 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
Inclusion 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
    Exclusion Criteria
    • 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)
SMR Stemless Reverse Vs SMR Reverse Shoulder System

Location Details

NCT04697004

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

WITHDRAWN

United States, California

Cedars-Sinai Kerlan-Jobe Institute

Los Angeles, California, United States, 90045

ACTIVE NOT RECRUITING

United States, Colorado

Western Orthopaedics

Denver, Colorado, United States, 80218

RECRUITING

United States, Florida

Levy Shoulder Center

Boca Raton, Florida, United States, 33428

RECRUITING

United States, Florida

AdventHealth

Orlando, Florida, United States, 32803

RECRUITING

United States, Illinois

Rush Orthopaedics

Chicago, Illinois, United States, 60612

RECRUITING

United States, New York

Upstate Orthopedics

East Syracuse, New York, United States, 13057

ACTIVE NOT RECRUITING

United States, North Carolina

Duke University

Durham, North Carolina, United States, 27708

WITHDRAWN

United States, Pennsylvania

University of Pennsylvania

Philadelphia, Pennsylvania, United States, 19104

RECRUITING

United States, Pennsylvania

Rothman Orthopaedic

Philadelphia, Pennsylvania, United States, 19107

RECRUITING

United States, Pennsylvania

Guthrie

Sayre, Pennsylvania, United States, 18840

RECRUITING

United States, Texas

University of Texas- Health Science Center

Saint Anthony, Texas, United States, 78229