Arthroplasty, Replacement study: SMR Stemless Reverse
Official title SMR Stemless Reverse vs SMR Reverse Shoulder System
ClinicalTrials.gov ID: NCT04697004
What this study is testing
- What it's testing
- The SMR Stemless Reverse is intended for total, primary shoulder joint replacement by reducing pain and restoring shoulder articular mobility function.
Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 22 and older
You may be able to join if
- Age ≥ 22 years of age
- Skeletally mature as evident by scapula and proximal humerus closure
- Arthritis with rotator cuff tear not reparable
- Irreparable rotator cuff tear
- Rotator cuff tear arthropathy
You likely can't join 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
See the full eligibility criteria
- Age ≥ 22 years of age
- Skeletally mature as evident by scapula and proximal humerus closure
- 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
- 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)
The study team makes the final eligibility decision.
Where it is enrolling
- Boca Raton, Florida, United States
- Orlando, Florida, United States
- Tampa, Florida, United States
- Fishers, Indiana, United States
- East Syracuse, New York, United States
- Philadelphia, Pennsylvania, United States
- Sayre, Pennsylvania, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 22 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Boca Raton, Florida, United States; Orlando, Florida, United States; Tampa, Florida, United States; Fishers, Indiana, United States; East Syracuse, New York, United States; Philadelphia, Pennsylvania, United States and 1 more location. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.