Arthroplasty, Replacement, ShoulderNCT05339815
S-33 SMR Shoulder HP Reverse Glenosphere
An observational study of Arthroplasty, Replacement, Shoulder, run by Limacorporate S.p.a at 1 site in United Kingdom.
Trial summary
Study Design: Single arm, retrospective and prospective, single center, post-market clinical study Purpose:To demonstrate the safety and effectiveness of the SMR Reverse HP Shoulder System device for primary, fracture or revision total shoulder replacement out to 24 months. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Arthroplasty, Replacement, Shoulder
- What is being tested?
- SMR shoulder arthroplasty
- Type of treatment
- Medical device
- How many people
- 205 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 17 Oct 2022to 11 Jan 2024
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The eligible study population is the entire population that underwent a reverse shoulder arthroplasty performed with 36-mm CoCrMo versus 40-mm cross-linked UHMWPE glenospheres between January 1, 2013 and January 1, 2020 at Wrightington Hospital (UK) in accordance with the indication for use of the product.
Who may be able to join
- Patient was treated with the SMR Reverse Shoulder System device (either with 36-mm CoCrMo glenosphere or 40-mm cross-linked UHMWPE glenosphere) between January 1, 2013 and January 1, 2020 as per Instruction for Use
- Patient was an adult male or female and was 18 years of age or older at the time of surgery
- Patient received the SMR Reverse Shoulder System for primary, fracture, or revision total shoulder replacement in a grossly rotator cuff deficient joint with severe arthroplasty
- The patient's joint was anatomically and structurally suited to receive the selected implants, with a functional deltoid muscle
- Surgery date is at least 24 months from screening of data
- Patient has baseline radiographs and Oxford Shoulder Score
Who cannot join
- 1 Patient was treated with the SMR Reverse Shoulder System device (either with 36-mm CoCrMo glenosphere or 40-mm cross-linked UHMWPE glenosphere) between January 1, 2013 and January 1, 2020 out of the Indications for Use
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Wrightington, Wigan and Leigh NHS Foundation Trust
Wigan
About this study
Official title: Clinical and Radiographic Outcomes of Reverse Shoulder Arthroplasty Performed With 36-mm CoCrMo vs 40-mm Cross-linked UHMWPE Glenospheres.
Study Design: Single arm, retrospective and prospective, single center, post-market clinical study Purpose:To demonstrate the safety and effectiveness of the SMR Reverse HP Shoulder System device for primary, fracture or revision total shoulder replacement out to 24 months. The eligible study population is the entire population that underwent a reverse shoulder arthroplasty performed with 36-mm CoCrMo versus 40-mm cross-linked UHMWPE glenospheres between January 1, 2013 and January 1, 2020 at Wrightington Hospital (UK) in accordance with the indication for use of the product.
- Conditions
- Arthroplasty, Replacement, Shoulder
- Being tested
- SMR shoulder arthroplasty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SMR shoulder arthroplastyDevice
Data collection of population that underwent a reverse shoulder arthroplasty performed with SMR 36-mm CoCrMo versus 40-mm cross-linked UHMWPE glenospheres
| Study group | Role | What they receive |
|---|---|---|
| 36 mm CoCrMo glenospheres | Not described Receives: Device: SMR shoulder arthroplasty | |
| 40 mm cross-linked UHMWPE glenospheres | Not described Receives: Device: SMR shoulder arthroplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary endpoint is based upon achieving composite clinical success (CCS)
The primary endpoint is based upon achieving composite clinical success (CCS) from baseline to 24-month follow-up measured as:
- No continuous radiolucent line around the implant
Glenoid Component Radiolucency will be graded in accordance with the following definitions:
- Absent: No evidence of radiolucency > 2 mm in width along the bone-implant interface in any zone.
- Present: Presence of radiolucency > 2 mm in width along the bone-implant interface in one or more zones
Measured: From baseline to FU 24 months
The primary endpoint is based upon achieving composite clinical success (CCS)
The primary endpoint is based upon achieving composite clinical success (CCS) from baseline to 24-month follow-up measured as:
- Change from baseline of the Oxford Should Score ≥ 6 points.
Oxford Shoulder Score (OSS) is a 12-item patient-reported PRO specifically designed and developed for assessing outcomes of shoulder surgery.
Measured: From baseline to FU 24 months
The primary endpoint is based upon achieving composite clinical success (CCS)
The primary endpoint is based upon achieving composite clinical success (CCS) from baseline to 24-month follow-up measured as:
- No revision or removals.
A removal of the glenosphere component is intended as a revision and of the implant.
Measured: From baseline to FU 24 months
The primary endpoint is based upon achieving composite clinical success (CCS)
The primary endpoint is based upon achieving composite clinical success (CCS) from baseline to 24-month follow-up measured as:
No system-related SAE (device-related)
Device Related Adverse Events/Serious Adverse Events, device deficiencies, malfunctions and use errors at all follow-up time points.
Measured: From baseline to FU 24 months
Secondary outcomes (6)
Assessment of the clinical evaluation of the SMR Reverse glenosphere used in real life settings over a period of 2 years (24 months) through PROMs when available and medical evaluation.
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: From baseline to FU 24 months
Assessment of the clinical evaluation of the SMR Reverse glenosphere used in real life settings over a period of 2 years (24 months) through PROMs when available and medical evaluation.
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: From baseline to FU 24 months
Assessment of the clinical evaluation of the SMR Reverse glenosphere used in real life settings over a period of 2 years (24 months) through PROMs when available and medical evaluation.
Measure American Shoulder and Elbow Surgeons Shoulder Score (ASES)
American Shoulder and Elbow Surgeons (ASES) score contains a patient self-report section and a section used by medical professionals to record physical examination findings to assess patients with shoulder pathologies.
The patient self-report section of the ASES is a condition specific scale is intended to measure functional limitations and pain of the shoulder. The pain score is calculated from the single pain question and the function score from the sum of the 10 questions addressing function. The pain score and function composite score are weighted equally (50 points each) and combined for a total score out of a possible 100 points.
The physician assessment section is composed by 4 parts: motion, stability, strength and physical findings.
Measured: From baseline to FU 24 months
Assessment of the clinical evaluation of the SMR Reverse glenosphere used in real life settings over a period of 2 years (24 months) through PROMs when available and medical evaluation.
Measure Quick DASH
The QuickDASH is scored in two components: the disability/symptom section (11 items, scored 1-5) and the optional high performance sport/music or work modules (4 items, scored 1-5). At least 10 of the 11 items must be completed for a score to be calculated. All items are scored on a scale of 5 (Likert) levels: 1 = no difficulty/symptoms, 2 = mild difficulty/symptoms, 3 = moderate difficulty/symptoms, 4 = severe difficulty/symptoms, and 5 = extreme difficulty (unable to do)/symptoms.
The assigned values for all completed responses are simply summed and averaged, producing a score out of five. This value is then transformed to a score out of 100 by subtracting one and multiplying by 25. This transformation is done to make the score easier to compare to other measures scaled on a 0-100 scale. A higher score indicates greater disability.
Measured: From baseline to FU 24 months
Survivorship of the implant (Kaplan-Meier estimate) through 2 years (24 months) of follow-up after surgery
Kaplan-Meier
Measured: From baseline to FU 24 months
Incidence, type and severity of all Adverse Events (AEs), Serious Adverse Events (SAEs), Adverse Device Effect (ADEs), Serious Adverse Device Effects (SADEs)
Device Related Adverse Events/Serious Adverse Events, device deficiencies, malfunctions and use errors at all follow-up time points
Measured: From baseline to FU 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2022
- Study start17 Oct 2022
- Primary completion11 Jan 2024
- Study completion11 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arthroplasty, Replacement, ShoulderStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 205 participants (actual)
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
- NCT05339815
- Sponsor's protocol ID
- S-33
- Status last verified
- Jun 2026
- First submitted
- 8 Apr 2022
- Last updated
- 12 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Radiographic Outcomes of Reverse Shoulder Arthroplasty Performed With 36-mm CoCrMo vs 40-mm Cross-linked UHMWPE Glenospheres.
- ClinicalTrials.gov ID
- NCT05339815
- Acronym / sponsor ID
- S-33
- Conditions
- Arthroplasty, Replacement, Shoulder
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 205 participants (actual)
- Lead sponsor
- Limacorporate S.p.aIndustry (pharma, biotech, devices)
- Study start
- 17 Oct 2022 (actual)
- Primary completion
- 11 Jan 2024 (actual)
- Study completion
- 11 Jan 2024 (actual)
- First posted
- 21 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.
Study Design: Single arm, retrospective and prospective, single center, post-market clinical study Purpose:To demonstrate the safety and effectiveness of the SMR Reverse HP Shoulder System device for primary, fracture or revision total shoulder replacement out to 24 months. The eligible study population is the entire population that underwent a reverse shoulder arthroplasty performed with 36-mm CoCrMo versus 40-mm cross-linked UHMWPE glenospheres between January 1, 2013 and January 1, 2020 at Wrightington Hospital (UK) in accordance with the indication for use of the product.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 36 mm CoCrMo glenospheres | – | Device: SMR shoulder arthroplasty |
| 40 mm cross-linked UHMWPE glenospheres | – | Device: SMR shoulder arthroplasty |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The eligible study population is the entire population that underwent a reverse shoulder arthroplasty performed with 36-mm CoCrMo versus 40-mm cross-linked UHMWPE glenospheres between January 1, 2013 and January 1, 2020 at Wrightington Hospital (UK) in accordance with the indication for use of the product.
Key inclusion criteria (6 listed)
- Patient was treated with the SMR Reverse Shoulder System device (either with 36-mm CoCrMo glenosphere or 40-mm cross-linked UHMWPE glenosphere) between January 1, 2013 and January 1, 2020 as per Instruction for Use
- Patient was an adult male or female and was 18 years of age or older at the time of surgery
- Patient received the SMR Reverse Shoulder System for primary, fracture, or revision total shoulder replacement in a grossly rotator cuff deficient joint with severe arthroplasty
- The patient's joint was anatomically and structurally suited to receive the selected implants, with a functional deltoid muscle
- Surgery date is at least 24 months from screening of data
Key exclusion criteria (1 listed)
- 1 Patient was treated with the SMR Reverse Shoulder System device (either with 36-mm CoCrMo glenosphere or 40-mm cross-linked UHMWPE glenosphere) between January 1, 2013 and January 1, 2020 out of the Indications for Use
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 shoulder arthroplastyData collection of population that underwent a reverse shoulder arthroplasty performed with SMR 36-mm CoCrMo versus 40-mm cross-linked UHMWPE glenospheres | Device | 36 mm CoCrMo glenospheres, 40 mm cross-linked UHMWPE glenospheres |
Primary outcome
The primary endpoint is based upon achieving composite clinical success (CCS)
Time frame: From baseline to FU 24 months
The primary endpoint is based upon achieving composite clinical success (CCS) from baseline to 24-month follow-up measured as: - No continuous radiolucent line around the implant Glenoid Component Radiolucency will be graded in accordance with the following definitions: 0. Absent: No evidence of radiolucency > 2 mm in width along the bone-implant interface in any zone. 1. Present: Presence of radiolucency > 2 mm in width along the bone-implant interface in one or more zones
The primary endpoint is based upon achieving composite clinical success (CCS)
Time frame: From baseline to FU 24 months
The primary endpoint is based upon achieving composite clinical success (CCS) from baseline to 24-month follow-up measured as: - Change from baseline of the Oxford Should Score ≥ 6 points. Oxford Shoulder Score (OSS) is a 12-item patient-reported PRO specifically designed and developed for assessing outcomes of shoulder surgery.
The primary endpoint is based upon achieving composite clinical success (CCS)
Time frame: From baseline to FU 24 months
The primary endpoint is based upon achieving composite clinical success (CCS) from baseline to 24-month follow-up measured as: - No revision or removals. A removal of the glenosphere component is intended as a revision and of the implant.
The primary endpoint is based upon achieving composite clinical success (CCS)
Time frame: From baseline to FU 24 months
The primary endpoint is based upon achieving composite clinical success (CCS) from baseline to 24-month follow-up measured as: No system-related SAE (device-related) Device Related Adverse Events/Serious Adverse Events, device deficiencies, malfunctions and use errors at all follow-up time points.
6 secondary outcomes
Assessment of the clinical evaluation of the SMR Reverse glenosphere used in real life settings over a period of 2 years (24 months) through PROMs when available and medical evaluation.
Time frame: From baseline to FU 24 months
Assessment of the clinical evaluation of the SMR Reverse glenosphere used in real life settings over a period of 2 years (24 months) through PROMs when available and medical evaluation.
Time frame: From baseline to FU 24 months
Assessment of the clinical evaluation of the SMR Reverse glenosphere used in real life settings over a period of 2 years (24 months) through PROMs when available and medical evaluation.
Time frame: From baseline to FU 24 months
Assessment of the clinical evaluation of the SMR Reverse glenosphere used in real life settings over a period of 2 years (24 months) through PROMs when available and medical evaluation.
Time frame: From baseline to FU 24 months
Survivorship of the implant (Kaplan-Meier estimate) through 2 years (24 months) of follow-up after surgery
Time frame: From baseline to FU 24 months
Incidence, type and severity of all Adverse Events (AEs), Serious Adverse Events (SAEs), Adverse Device Effect (ADEs), Serious Adverse Device Effects (SADEs)
Time frame: From baseline to FU 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2026.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Arthroplasty, Replacement, Shoulder, run by Limacorporate S.p.a at 1 site in United Kingdom.
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 6 inclusion and 1 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: finished, as of the sponsor's last update on 12 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary endpoint is based upon achieving composite clinical success (CCS) (time frame: From baseline to FU 24 months). The study lists 4 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 12 Jun 2026; AzTrials last refreshed its copy on 30 Oct 2026.