Shoulder ArthritisNCT05314387
S-11 SMR TT Hybrid Glenoid and Cementless Finned Short Stem
An observational study of Shoulder Arthritis and Shoulder Osteoarthritis, run by Limacorporate S.p.a.
Trial summary
Post-market, prospective, non randomized, open label, multicentre, clinical study analysing outcomes of shoulder arthroplasty with SMR TT Hybrid Glenoid with or without SMR Cementless Finned Short Stem Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Shoulder Arthritis, Shoulder Osteoarthritis, Arthrosis
- What is being tested?
- SMR TT Hybrid Glenoid without Cementless Finned Short Stem and SMR TT Hybrid Glenoid with Cementless Finned Short Stem
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Apr 2022to Apr 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Orthopedic Clinics
Who may be able to join
- Both genders;
- Age ≥ 18 years old;
- Full skeletal maturity;
- Life expectancy over 5 years;
- Patient is requiring primary unilateral arthroplasty based on physical examination and medical history;
- Good bone quality evaluated by the Investigator and the intraoperative evaluation;
Show all 15Show fewer
- A diagnosis in the target shoulder of one or more of the S-11 SMR TT Hybrid Glenoid and Cementless Finned Short Stem Version Sep 2021 2.0 Confidential Page11 following:
- Primary osteoarthritis;
- Secondary osteoarthritis;
- Post-traumatic arthritis;
- Rheumatoid arthritis;
- Avascular necrosis
- acute fractures of the humeral head that cannot be treated with other fracture fixation methods;
- cuff tear arthropathy (only in combination with CTA Heads);
- Glenoid arthrosis without excessive glenoid bone loss: A1, A2 and B1 according to Walch classification.
Who cannot join
- Patient requiring revision shoulder arthroplasty;
- Osteoporosis with a history of non-traumatic fractures;
- Steroid injections within the previous 3 months;
- Contralateral shoulder replacement within the previous 3 months;
- Significant proven or suspicious infection of the target shoulder or any serious infectious disease before the study according to the Investigator;
- Significant neurological or musculoskeletal disorders that may compromise functional recovery;
Show all 12Show fewer
- Not recovered axillary nerve palsy;
- Non functioning deltoid muscle;
- Known or suspicious hypersensitivity to the metal or other components and materials of the implant;
- Participation in any experimental drug/device study within the 6 months prior to the preoperative visit;
- Women of childbearing potential who are pregnant, nursing, or planning to become pregnant.
- These are key eligibility criteria, other eligibility criteria apply.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Multicentre, Prospective Clinical Study Analysing Outcomes of Shoulder Arthroplasty With SMR TT Hybrid Glenoid With or Without SMR Cementless Finned Short Stem
Post-market, prospective, non randomized, open label, multicentre, clinical study analysing outcomes of shoulder arthroplasty with SMR TT Hybrid Glenoid with or without SMR Cementless Finned Short Stem
- Conditions
- Shoulder Arthritis, Shoulder Osteoarthritis, Arthrosis, Osteoarthritis, Rheumatoid Arthritis, Arthroplasty
- Being tested
- SMR TT Hybrid Glenoid without Cementless Finned Short Stem, SMR TT Hybrid Glenoid with Cementless Finned Short Stem
- Keywords
- Shoulder Joint, Shoulder Replacement, Arthritis with rotator cuff tear, Post traumatic fracture sequele
- Medical subject headings
- Osteoarthritis, Arthritis, Rheumatoid, Osteonecrosis, Humeral Fractures, Rotator Cuff Tear Arthropathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SMR TT Hybrid Glenoid without Cementless Finned Short StemDevice
The subject SMR Hybrid Glenoid System and SMR cementless finned short stem is intended for both primary or revision anatomic and reverse shoulder joint replacement. The glenoid components when used as part of an anatomic shoulder replacement are intended for cemented fixation.
SMR TT Hybrid Glenoid with Cementless Finned Short StemDevice
The subject SMR Hybrid Glenoid System and SMR cementless finned short stem is intended for both primary or revision anatomic and reverse shoulder joint replacement. The glenoid components when used as part of an anatomic shoulder replacement are intended for cemented fixation.
The fins are intended to enhance press-fit fixation. The same proximal morse taper is used for coupling to the same humeral bodies in the SMR Shoulder System. The SMR finned short stem is intended for cementless fixation.
| Study group | Role | What they receive |
|---|---|---|
| SMR TT Hybrid Glenoid without Cementless Finned Short Stem | Patients implanted with SMR TT Hybrid Glenoid without Cementless Finned Short Stem Receives: Device: SMR TT Hybrid Glenoid without Cementless Finned Short Stem | |
| SMR TT Hybrid Glenoid with Cementless Finned Short Stem | Patients implanted with SMR TT Hybrid Glenoid with Cementless Finned Short Stem Receives: Device: SMR TT Hybrid Glenoid with Cementless Finned Short Stem |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients reaching a clinical progression from baseline to 24-month follow-up
The primary endpoint consists of the proportion of patients reaching a clinical progression from baseline to 24-month follow-up measured as:
- Constant score improvement of greater than 10;
- Adjusted Constant score greater than or equal to 54.
Measured: 24 Months
Secondary outcomes (11)
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: Baseline to 24 and 60 Months
Measure Oxford shoulder score
Oxford Shoulder Score (OSS) is a 12-item patient-reported PRO specifically designed and developed for assessing outcomes of shoulder surgery.
Measured: Baseline to 24 and 60 Months
Measure Constant 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: Baseline to 24 and 60 Months
Measure Simple Shoulder Test
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: Baseline to 24 and 60 Months
Measure Patient Satisfaction
The satisfaction of the patients with regard to the effectiveness of the prosthetic treatment is graded on a scale from 1 to 5
Measured: Baseline to 24 and 60 Months
Stability of the SMR TT hybrid glenoid component with or without SMR cementless finned short stem
Rate of symptomatic radiolucent lines, loosening and subsidence ≥2 mm
Measured: Immediately postoperative to 24 Months
System conversion rate, intended as a conversion within the SMR system from anatomic to reverse
The SMR shoulder system is a modular system and in case of evolution of the pathology it may be easily converted from one configuration to another.
Measured: 24 Months
Failure rate, intended as removal of the SMR TT hybrid glenoid component
A removal of the glenoid component is intended as a revision and a failure of the implant.
Measured: Immediately postoperative to 24 Months
Failure rate, intended as removal of the SMR cementless finned short stem
A removal of the stem component is intended as a revision and a failure of the implant.
Measured: Immediately postoperative to 24 Months
Incidence of device-related AE/SAE (ADE/SADE)
Device Related Adverse Events/Serious Adverse Events, device deficiencies, malfunctions and use errors at all follow-up time points
Measured: Immediately postoperative to 24 and 60 Months
Survival rate (Kaplan-Meier)
Measured: 60 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2022
- Study startApr 2022 (estimated)
- Primary completionApr 2027 (estimated)
- Study completionApr 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Shoulder ArthritisStudies of the same condition, open and under way.
- More trials run by Limacorporate S.p.aThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Limacorporate S.p.a
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05314387
- Sponsor's protocol ID
- S-11
- Status last verified
- Mar 2022
- First submitted
- 18 Mar 2022
- Last updated
- 6 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- 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 6 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicentre, Prospective Clinical Study Analysing Outcomes of Shoulder Arthroplasty With SMR TT Hybrid Glenoid With or Without SMR Cementless Finned Short Stem
- ClinicalTrials.gov ID
- NCT05314387
- Acronym / sponsor ID
- S-11
- Conditions
- Shoulder Arthritis, Shoulder Osteoarthritis, Arthrosis, Osteoarthritis, Rheumatoid Arthritis, Arthroplasty
- Keywords
- Shoulder Joint, Shoulder Replacement, Arthritis with rotator cuff tear, Post traumatic fracture sequele
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Limacorporate S.p.aIndustry (pharma, biotech, devices)
- Study start
- Apr 2022 (estimated)
- Primary completion
- Apr 2027 (estimated)
- Study completion
- Apr 2029 (estimated)
- First posted
- 6 Apr 2022 (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.
Post-market, prospective, non randomized, open label, multicentre, clinical study analysing outcomes of shoulder arthroplasty with SMR TT Hybrid Glenoid with or without SMR Cementless Finned Short Stem
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SMR TT Hybrid Glenoid without Cementless Finned Short Stem | – | Device: SMR TT Hybrid Glenoid without Cementless Finned Short StemPatients implanted with SMR TT Hybrid Glenoid without Cementless Finned Short Stem |
| SMR TT Hybrid Glenoid with Cementless Finned Short Stem | – | Device: SMR TT Hybrid Glenoid with Cementless Finned Short StemPatients implanted with SMR TT Hybrid Glenoid with Cementless Finned Short Stem |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Orthopedic Clinics
Key inclusion criteria (15 listed)
- Both genders;
- Age ≥ 18 years old;
- Full skeletal maturity;
- Life expectancy over 5 years;
- Patient is requiring primary unilateral arthroplasty based on physical examination and medical history;
Key exclusion criteria (12 listed)
- Patient requiring revision shoulder arthroplasty;
- Osteoporosis with a history of non-traumatic fractures;
- Steroid injections within the previous 3 months;
- Contralateral shoulder replacement within the previous 3 months;
- Significant proven or suspicious infection of the target shoulder or any serious infectious disease before the study according to the Investigator;
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 |
|---|---|---|
| SMR TT Hybrid Glenoid without Cementless Finned Short StemThe subject SMR Hybrid Glenoid System and SMR cementless finned short stem is intended for both primary or revision anatomic and reverse shoulder joint replacement. The glenoid components when used as part of an anatomic shoulder replacement are intended for cemented fixation. | Device | SMR TT Hybrid Glenoid without Cementless Finned Short Stem |
| SMR TT Hybrid Glenoid with Cementless Finned Short StemThe subject SMR Hybrid Glenoid System and SMR cementless finned short stem is intended for both primary or revision anatomic and reverse shoulder joint replacement. The glenoid components when used as part of an anatomic shoulder replacement are intended for cemented fixation. The fins are intended to enhance press-fit fixation. The same proximal morse taper is used for coupling to the same humeral bodies in the SMR Shoulder System. The SMR finned short stem is intended for cementless fixation. | Device | SMR TT Hybrid Glenoid with Cementless Finned Short Stem |
Primary outcome
Proportion of patients reaching a clinical progression from baseline to 24-month follow-up
Time frame: 24 Months
The primary endpoint consists of the proportion of patients reaching a clinical progression from baseline to 24-month follow-up measured as: * Constant score improvement of greater than 10; * Adjusted Constant score greater than or equal to 54.
11 secondary outcomes
Measure American Shoulder and Elbow Surgeons Shoulder Score (ASES)
Time frame: Baseline to 24 and 60 Months
Measure Oxford shoulder score
Time frame: Baseline to 24 and 60 Months
Measure Constant Score
Time frame: Baseline to 24 and 60 Months
Measure Simple Shoulder Test
Time frame: Baseline to 24 and 60 Months
Measure Patient Satisfaction
Time frame: Baseline to 24 and 60 Months
Stability of the SMR TT hybrid glenoid component with or without SMR cementless finned short stem
Time frame: Immediately postoperative to 24 Months
System conversion rate, intended as a conversion within the SMR system from anatomic to reverse
Time frame: 24 Months
Failure rate, intended as removal of the SMR TT hybrid glenoid component
Time frame: Immediately postoperative to 24 Months
Failure rate, intended as removal of the SMR cementless finned short stem
Time frame: Immediately postoperative to 24 Months
Incidence of device-related AE/SAE (ADE/SADE)
Time frame: Immediately postoperative to 24 and 60 Months
Survival rate (Kaplan-Meier)
Time frame: 60 Months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2022.
- Individual participant dataSharing planned: No
Related trials for Shoulder Arthritis
Not yet recruiting
Comparison of High-Intensity and Conventional Physical Therapy in Musculoskeletal Disorders
Low Back Pain, Radicular Syndrome
Recruiting
SMR Stemless Reverse vs SMR Reverse Shoulder System
Arthroplasty, Replacement
Active, not recruiting
Efficacy and Safety of Digital Therapeutics for Improving Shoulder Function After Rotator Cuff Repair
Rotator Cuff Tear Arthropathy, Repair of a Cuff Tear
Not yet recruitingObservational study
Clinical Validation of SMARTDIAGO for Remote Functional Assessment of Musculoskeletal Conditions
Knee Osteoarthristis, Hip Osteoarthritis
RecruitingObservational study
Evaluating Hemidiaphragmatic Paralysis With Prolonged Neural Blockade From an Interscalene Brachial Plexus Block
Shoulder Surgery, Shoulder Pain
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.
Questions about this trial
What is this clinical trial studying?
An observational study of Shoulder Arthritis and Shoulder Osteoarthritis, run by Limacorporate S.p.a.
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 15 inclusion and 12 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: opening soon, as of the sponsor's last update on 6 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Laura Sanchez (817-233-1686, laura.sanchez@limacorporate.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients reaching a clinical progression from baseline to 24-month follow-up (time frame: 24 Months). 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 6 Apr 2022.