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SMR Stemless Reverse vs SMR Reverse Shoulder System

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04697004
Recruitment Status : Recruiting
First Posted : January 6, 2021
Last Update Posted : April 4, 2023
Sponsor:
Collaborator:
NAMSA
Information provided by (Responsible Party):
Limacorporate S.p.a

Study Description
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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 Intervention/treatment Phase
Arthroplasty, Replacement Device: Investigational Arm: SMR Stemless Reverse Device: Control Arm: SMR Reverse Shoulder System Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: The 200 randomized subjects will be randomized 1:1 to SMR Stemless Reverse and SMR Reverse Shoulder System.
Masking: None (Open Label)
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 : April 1, 2021
Estimated Primary Completion Date : March 30, 2026
Estimated Study Completion Date : March 30, 2026

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: SMR Stemless Reverse Device: Investigational Arm: SMR Stemless Reverse
The SMR Stemless Reverse is intended for total, primary shoulder joint replacement by reducing pain and restoring shoulder articular mobility function.
Active Comparator: SMR Reverse Shoulder System Device: Control Arm: SMR Reverse Shoulder System
Conventional stemmed shoulder prostheses are commonly used in the clinical practice.


Outcome Measures
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Primary Outcome Measures :
  1. Primary Efficacy Endpoint-Constant Murley Score [ Time Frame: 24 Months ]

    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.


  2. Primary Safety Endpoint-Absence of revisions, reoperations, and implant loosening. [ Time Frame: 24 Months ]
    • 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.


Secondary Outcome Measures :
  1. Secondary Efficacy Measure-Constant-Murley Score [ Time Frame: 3, 6, and 12 month visits ]
    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.

  2. Secondary Efficacy Measure-American Shoulder and Elbow Surgeons Shoulder Score (ASES) [ Time Frame: 3, 6, 12 and 24 month visits ]
    The ASES questionnaire is composed of both a physician-rated component and a patient-reported component. The patient questions focus on joint pain, instability, and activities of daily living. Scores range from 0 to 100 with a score of 0 indicating a worse shoulder condition and 100 indicating a better shoulder condition.

  3. Secondary Efficacy Measure-Simple Shoulder Test (SST) [ Time Frame: 3, 6, 12 and 24 month visits ]
    Simple Shoulder Test (SST) is a series of 12 "yes" or "no" questions the patient answers about the function of the involved shoulder. The answers to these questions provides a standardized way of recording the function of a shoulder before and after treatment. The difference between the shoulder function before treatment and after the recovery period is the effectiveness of the treatment.

  4. Secondary Efficacy Measure-EQ-5D-5L [ Time Frame: 3, 6, 12 and 24 month visits ]
    The EQ-5D-5L is a self-assessed, health related, quality of life questionnaire. The scale measures quality of life on a 5-component scale including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. This tool also has an overall health scale where the rater selects a number between 1-100 to describe the condition of their health, 100 being the best imaginable condition of health.

  5. Secondary Efficacy Measure-Range of Motion (ROM) [ Time Frame: 3, 6, 12 and 24 month visits ]
    will be summarized using the mean, standard deviation, sample size, median and minimum and maximum scores and will be presented separately for the SMR Stemless Reverse and SMR Reverse Shoulder System implant groups.

  6. Secondary Efficacy Measure-Single Assessment Numeric Evaluation (SANE) [ Time Frame: 3, 6, 12 and 24 month visits ]
    The Single Assessment Numeric Evaluation (SANE) is a simple, one-question patient-reported outcome measures. Patient reported outcome measures (PROMs) quantify symptoms and limitations in people with musculoskeletal illness. The Single Assessment Numeric Evaluation (SANE) is a patient rating from 0-100. Patients rate their current illness score in relation to their pre-injury baseline.

  7. Secondary Safety Measure-Serious Procedure or Device Related Adverse Events [ Time Frame: From enrollment to the final study visit (24 months) ]
    Serious Procedure or Device Related Adverse Events, device deficiencies, malfunctions and use errors at all follow-up time points

  8. Secondary Safety Measure-Absence of Subsequent Secondary Surgical Interventions [ Time Frame: From enrollment to the final study visit (24 months) ]

    Absence of:

    • Removals - A removal is a procedure where all of the original system configuration is removed with or without replacement due to, for example, mechanical failure of the device, pain, or infection.
    • Supplemental Fixations - A supplemental fixation is a procedure in which additional instrumentation not under study in the protocol is implanted (e.g., supplemental placement of a rod/screw)

  9. Secondary Safety Measure-Radiographic: Standard CT and x-ray scans [ Time Frame: From enrollment to the final study visit (24 months) ]
    Presence/absence of and fracture, radiolucent , migration, mal-alignment or loss of reduction or fixation.


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   22 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04697004


Contacts
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Contact: Fabiana Pavan +39 348 5816391 Fabiana.Pavan@limacorporate.com
Contact: Tory Sears 574-377-1563 tsears@namsa.com

Locations
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United States, California
Cedars-Sinai Kerlan-Jobe Institute Withdrawn
Los Angeles, California, United States, 90045
United States, Colorado
Western Orthopaedics Recruiting
Denver, Colorado, United States, 80218
Contact: Libby Mauter    303-321-1333    LMauter@Western-Ortho.com   
Principal Investigator: Armand Hatzidakis, MD         
United States, Florida
AdventHealth Recruiting
Orlando, Florida, United States, 32803
Contact: Carissa Davy       Carissa.davy@adventhealth.com   
Contact: Rosemary Vargas       Rosemary.Vargas@AdventHealth.com   
Principal Investigator: George Huffman, MD         
United States, Illinois
Rush Orthopaedics Not yet recruiting
Chicago, Illinois, United States, 60612
Contact: Kavita Ahuja    224-229-2988    Kavita.ahuja@rushortho.com   
Principal Investigator: Grant Garrigues, MD         
Sub-Investigator: Gregory Nicholson, MD         
Sub-Investigator: Brian Cole, MD         
Sub-Investigator: Nikhil Verma, MD         
United States, New York
Upstate Orthopedics Recruiting
East Syracuse, New York, United States, 13057
Contact: Tina Craig    315-464-8618    CraigT@upstate.edu   
Principal Investigator: Kevin Setter, MD         
United States, North Carolina
Duke University Recruiting
Durham, North Carolina, United States, 27708
Contact: Suzanne Finley       suzanne.finley@duke.edu   
Principal Investigator: Oke Anakwenze, MD         
United States, Pennsylvania
University of Pennsylvania Withdrawn
Philadelphia, Pennsylvania, United States, 19104
Rothman Orthopaedic Recruiting
Philadelphia, Pennsylvania, United States, 19107
Contact: Thema Nicolson    267-339-3615    Thema.Nicholson@rothmanortho.com   
Principal Investigator: Joseph Abboud, MD         
Guthrie Not yet recruiting
Sayre, Pennsylvania, United States, 18840
Contact: Brent Bloomquist       Brent.Bloomquist@guthrie.org   
Principal Investigator: Joseph Choi, MD         
United States, Texas
University of Texas- Health Science Center Not yet recruiting
San Antonio, Texas, United States, 78229
Contact: Ruby Samuel         
Principal Investigator: Anil Dutta, MD         
Sponsors and Collaborators
Limacorporate S.p.a
NAMSA
Investigators
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Principal Investigator: Grant Garrigues, M.D. Rush Orthopedics
More Information
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Responsible Party: Limacorporate S.p.a
ClinicalTrials.gov Identifier: NCT04697004    
Other Study ID Numbers: S-34
First Posted: January 6, 2021    Key Record Dates
Last Update Posted: April 4, 2023
Last Verified: January 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Keywords provided by Limacorporate S.p.a:
Shoulder Joint
Shoulder Replacement
Arthritis with rotator cuff tear
Post traumatic fracture sequele
 Severe osteoarthritis and rotator cuff deficiency
Significant glenoid or socket side bone deformed or loss
Reoccurrence of instability or chronic shoulder dislocation
Severe osteoarthritis and stiff shoulder