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SMR Stemless Reverse vs SMR Reverse Shoulder System

Limacorporate S.p.a · with NAMSA · NCT04697004

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 22+ · All sexes
Healthy volunteers
Not accepted (a condition is required)
Study type
Interventional · Not applicable
Target enrollment
200
US sites recruiting
7
Study start
April 1, 2021
Record last updated
October 28, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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.

Being studied: Investigational Arm: SMR Stemless Reverse; Control Arm: SMR Reverse Shoulder System

Conditions: Arthroplasty, Replacement

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

Inclusion Criteria

  • 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 Criteria

  • 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)

Recruiting US locations

  • Levy Shoulder Center

    Boca Raton, FL 33428

    Site contact: Janice Schuck

  • AdventHealth

    Orlando, FL 32803

    Site contact: Carissa Davy · Carissa.davy@adventhealth.com

  • Foundation for Orthopaedic Research and Education

    Tampa, FL 33607

    Site contact: Debbi Warren, RN, CCRC, ACRP-CP · 813-738-6457 · dwarren@foreonline.org

  • Central Indiana Orthopedics

    Fishers, IN 46037

    Site contact: Brad Crackel · Brad_crackel@ciocenter.com

  • Upstate Orthopedics

    East Syracuse, NY 13057

    Site contact: Tina Craig · 3154648618 · CraigT@upstate.edu

  • Rothman Orthopaedic

    Philadelphia, PA 19107

    Site contact: Thema Nicolson · (267) 339-3615 · Thema.Nicholson@rothmanortho.com

  • Guthrie

    Sayre, PA 18840

    Site contact: Brent Bloomquist · Brent.Bloomquist@guthrie.org

Study contacts (from the official record)

  • Fabiana Pavan · +39 348 5816391 · Fabiana.Pavan@limacorporate.com
  • Kelsey Breuning · kbreuning@namsa.com
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SMR Stemless Reverse vs SMR Reverse Shoulder System (NCT04697004) | Bored Studies