Arthroplasty, ReplacementNCT04697004
SMR Stemless Reverse Vs SMR Reverse Shoulder System
A study testing Investigational Arm: SMR Stemless Reverse in people with Arthroplasty, Replacement, run by Limacorporate S.p.a at 11 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Arthroplasty, Replacement
- What is being tested?
- Investigational Arm: SMR Stemless Reverse
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 11 sitesUnited States
- Study dates
- 1 Apr 2021to 30 Mar 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 10Show fewer
- 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
Who cannot join
- 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
Show all 13Show fewer
- 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)
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
United States11 sites, 7 recruiting
- Recruiting
Levy Shoulder Center
Boca Raton, Florida, 33428
Janice Schuck
Jonathan Levy, MD
- Recruiting
Rush Orthopaedics
Chicago, Illinois, 60612
Kavita Ahuja, 224-229-2988, Kavita.ahuja@rushortho.com
Grant Garrigues, MD
- Active, not recruiting
Western Orthopaedics
Denver, Colorado, 80218
- Active, not recruiting
Duke University
Durham, North Carolina, 27708
- Recruiting
Upstate Orthopedics
East Syracuse, New York, 13057
Tina Craig, 3154648618, CraigT@upstate.edu
Kevin Setter, MD
- Withdrawn
Cedars-Sinai Kerlan-Jobe Institute
Los Angeles, California, 90045
- Recruiting
AdventHealth
Orlando, Florida, 32803
Carissa Davy, Carissa.davy@adventhealth.com
Rosemary Vargas, Rosemary.Vargas@AdventHealth.com
- Withdrawn
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
- Recruiting
Rothman Orthopaedic
Philadelphia, Pennsylvania, 19107
Thema Nicolson, (267) 339-3615, Thema.Nicholson@rothmanortho.com
Joseph Abboud, MD
- Recruiting
University of Texas- Health Science Center
San Antonio, Texas, 78229
Ruby Samuel
Anil Dutta, MD
- Recruiting
Guthrie
Sayre, Pennsylvania, 18840
Brent Bloomquist, Brent.Bloomquist@guthrie.org
Joseph Choi, MD
About this study
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
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
- Being tested
- Investigational Arm: SMR Stemless Reverse, Control Arm: SMR Reverse Shoulder System
- Keywords
- 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
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Investigational Arm: SMR Stemless ReverseDevice
The SMR Stemless Reverse is intended for total, primary shoulder joint replacement by reducing pain and restoring shoulder articular mobility function.
Control Arm: SMR Reverse Shoulder SystemDevice
Conventional stemmed shoulder prostheses are commonly used in the clinical practice.
| Study group | Role | What they receive |
|---|---|---|
| SMR Stemless Reverse | Experimental | Not described Receives: Device: Investigational Arm: SMR Stemless Reverse |
| SMR Reverse Shoulder System | Active comparator | Not described Receives: Device: Control Arm: SMR Reverse Shoulder System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Efficacy Endpoint-Constant Murley Score
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.
Measured: 24 Months
Primary Safety Endpoint-Absence of revisions, reoperations, and implant loosening.
- 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.
Measured: 24 Months
Secondary outcomes (9)
Secondary Efficacy Measure-Constant-Murley Score
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.
Measured: 3, 6, and 12 month visits
Secondary Efficacy Measure-American Shoulder and Elbow Surgeons Shoulder Score (ASES)
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.
Measured: 3, 6, 12 and 24 month visits
Secondary Efficacy Measure-Simple Shoulder Test (SST)
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.
Measured: 3, 6, 12 and 24 month visits
Secondary Efficacy Measure-EQ-5D-5L
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.
Measured: 3, 6, 12 and 24 month visits
Secondary Efficacy Measure-Range of Motion (ROM)
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.
Measured: 3, 6, 12 and 24 month visits
Secondary Efficacy Measure-Single Assessment Numeric Evaluation (SANE)
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.
Measured: 3, 6, 12 and 24 month visits
Secondary Safety Measure-Serious Procedure or Device Related Adverse Events
Serious Procedure or Device Related Adverse Events, device deficiencies, malfunctions and use errors at all follow-up time points
Measured: From enrollment to the final study visit (24 months)
Secondary Safety Measure-Absence of Subsequent Secondary Surgical Interventions
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)
Measured: From enrollment to the final study visit (24 months)
Secondary Safety Measure-Radiographic: Standard CT and x-ray scans
Presence/absence of and fracture, radiolucent , migration, mal-alignment or loss of reduction or fixation.
Measured: From enrollment to the final study visit (24 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2021
- Study start1 Apr 2021
- Primary completion30 Mar 2026 (estimated)
- Study completion30 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arthroplasty, ReplacementStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The 200 randomized subjects will be randomized 1:1 to SMR Stemless Reverse and SMR Reverse Shoulder System.
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Limacorporate S.p.a
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- NAMSA
- Responsible party
- Sponsor
- Investigators
- Grant Garrigues, M.D., Principal investigator, Rush Orthopedics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04697004
- Sponsor's protocol ID
- S-34
- Status last verified
- Oct 2023
- First submitted
- 4 Jan 2021
- Last updated
- 2 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04697004
- Acronym / sponsor ID
- S-34
- Conditions
- Arthroplasty, Replacement
- Keywords
- 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
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Limacorporate S.p.aIndustry (pharma, biotech, devices)
- Collaborators
- NAMSA
- Study start
- 1 Apr 2021 (actual)
- Primary completion
- 30 Mar 2026 (estimated)
- Study completion
- 30 Mar 2026 (estimated)
- First posted
- 6 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The 200 randomized subjects will be randomized 1:1 to SMR Stemless Reverse and SMR Reverse Shoulder System.
| Arm | Type | Receives |
|---|---|---|
| SMR Stemless Reverse | Experimental | Device: Investigational Arm: SMR Stemless Reverse |
| SMR Reverse Shoulder System | Active comparator | Device: Control Arm: SMR Reverse Shoulder System |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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:
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Investigational Arm: SMR Stemless ReverseThe SMR Stemless Reverse is intended for total, primary shoulder joint replacement by reducing pain and restoring shoulder articular mobility function. | Device | SMR Stemless Reverse |
| Control Arm: SMR Reverse Shoulder SystemConventional stemmed shoulder prostheses are commonly used in the clinical practice. | Device | SMR Reverse Shoulder System |
Primary outcome
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.
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.
9 secondary outcomes
Secondary Efficacy Measure-Constant-Murley Score
Time frame: 3, 6, and 12 month visits
Secondary Efficacy Measure-American Shoulder and Elbow Surgeons Shoulder Score (ASES)
Time frame: 3, 6, 12 and 24 month visits
Secondary Efficacy Measure-Simple Shoulder Test (SST)
Time frame: 3, 6, 12 and 24 month visits
Secondary Efficacy Measure-EQ-5D-5L
Time frame: 3, 6, 12 and 24 month visits
Secondary Efficacy Measure-Range of Motion (ROM)
Time frame: 3, 6, 12 and 24 month visits
Secondary Efficacy Measure-Single Assessment Numeric Evaluation (SANE)
Time frame: 3, 6, 12 and 24 month visits
Secondary Safety Measure-Serious Procedure or Device Related Adverse Events
Time frame: From enrollment to the final study visit (24 months)
Secondary Safety Measure-Absence of Subsequent Secondary Surgical Interventions
Time frame: From enrollment to the final study visit (24 months)
Secondary Safety Measure-Radiographic: Standard CT and x-ray scans
Time frame: From enrollment to the final study visit (24 months)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Grant Garrigues, M.D. principal investigator
Rush Orthopedics
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Investigational Arm: SMR Stemless Reverse in people with Arthroplasty, Replacement, run by Limacorporate S.p.a at 11 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Fabiana Pavan (+39 348 5816391, Fabiana.Pavan@limacorporate.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Efficacy Endpoint-Constant Murley Score (time frame: 24 Months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2024.