Rotator Cuff Tear ArthropathySSPRNCT04529798
Clinical Study Evaluating Outcomes of Reverse Shoulder Arthroplasty With SMR Stemless
An observational study of Rotator Cuff Tear Arthropathy and Osteo Arthritis Shoulders, run by Arthro Medics AG at 1 site in Switzerland.
Trial summary
The objectives of this study are the assessment of the clinical, radiographical and patient-reported outcomes of SMR Stemless Reverse Shoulder Arthroplasty (LimaCorporate S.p.A.) used as standard of care over a period of at least 2 years of follow-up and the evaluation of the incidence of any complication. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rotator Cuff Tear Arthropathy, Osteo Arthritis Shoulders
- How many people
- 60 participants
- Where
- 1 siteSwitzerland
- Study dates
- 22 Nov 2016to 30 Aug 2025
- 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: There is a retrospective and prospective study population. All participants are older than 18 years old and approved the written informed consent. Additionally they are suffering from rotator-cuff arthropathy and/or osteoarthritis.
Who may be able to join
- rotator-cuff arthropathy, osteoarthritis
- approving written informed consent
Who cannot join
- Female patients who are pregnant, nursing, or planning a pregnancy.
- All adult patients with any of the SMR Stemless contraindication for use for the reverse configuration as reported in the current local Instruction for use.
- not consenting in participating in this study
Trial locations and contacts
1 site in 1 country.
Switzerland1 site, 1 recruiting
- Recruiting
Arthro Medics AG
Basel, Canton of Basel-City, 4054
Claudio Rosso, PD Dr. med., +41 61 301 26 26, c.rosso@arthro.ch
About this study
Official title: A Monocentric Clinical Study Evaluating Clinical and Patient-reported Outcomes of Reverse Shoulder Arthroplasty With SMR Stemless
The objectives of this study are the assessment of the clinical, radiographical and patient-reported outcomes of SMR Stemless Reverse Shoulder Arthroplasty (LimaCorporate S.p.A.) used as standard of care over a period of at least 2 years of follow-up and the evaluation of the incidence of any complication.
Read the detailed description
The focus of this study is the evaluation on clinical, patient-reported and radiographical outcomes of SMR Stemless Reverse Shoulder Arthroplasty. There is a retrospective and prospective study population.
The follow up time-points are (as of standard of care and not different for this study):
- Baseline
- 6 weeks postop
- 6 months postop
- 12 months postop
- 24 months postop
- Keywords
- stemless reverse shoulder arthroplasty
- Medical subject headings
- Rotator Cuff Tear Arthropathy
What is being measured
The primary outcome is the main question the study is designed to answer.
Subjective Shoulder Value score
Evaluation of the change of the Subjective Shoulder Value score from pre-operative to the last follow-up visit.
Measured: 5 years
Secondary outcomes (5)
ASES Shoulder Score
Evaluation of the change of the ASES shoulder score from pre-operative to the last follow-up visit.
Measured: 5 years
Quick-Dash score
Evaluation of the change of the Quick-Dash score from pre-operative to the last follow-up visit.
Measured: 5 years
VAS pain
Evaluation of the change of the VAS pain score from pre-operative to the last follow-up visit.
Measured: 5 years
UCLA shoulder score
Evaluation of the change of the UCLA shoulder score from pre-operative to the last follow-up visit.
Measured: 5 years
Loosening, implant stability, radiolucent lines
Radiographic evaluation of the implant stability as rate and progression of symptomatic radiolucent lines and loosening.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2020
- Study start22 Nov 2016
- Primary completion30 Aug 2024 (estimated)
- Study completion30 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rotator Cuff Tear ArthropathyStudies 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
- Cohort
- Time perspective
- Other
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Arthro Medics AG
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Dr. med Claudio Rosso, Arthro Medics AG
- Investigators
- Claudio Rosso, Prof. Dr. med., Principal investigator, Arthro Medics AG
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04529798
- Sponsor's protocol ID
- S-35
- Acronym
- SSPR
- Status last verified
- Jul 2024
- First submitted
- 25 Aug 2020
- Last updated
- 31 Jul 2024
- 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 31 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Monocentric Clinical Study Evaluating Clinical and Patient-reported Outcomes of Reverse Shoulder Arthroplasty With SMR Stemless
- ClinicalTrials.gov ID
- NCT04529798
- Acronym / sponsor ID
- SSPR / S-35
- Keywords
- stemless reverse shoulder arthroplasty
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Arthro Medics AGUniversity, hospital or other
- Study start
- 22 Nov 2016 (actual)
- Primary completion
- 30 Aug 2024 (estimated)
- Study completion
- 30 Aug 2025 (estimated)
- First posted
- 28 Aug 2020 (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 objectives of this study are the assessment of the clinical, radiographical and patient-reported outcomes of SMR Stemless Reverse Shoulder Arthroplasty (LimaCorporate S.p.A.) used as standard of care over a period of at least 2 years of follow-up and the evaluation of the incidence of any complication.
Detailed description
The focus of this study is the evaluation on clinical, patient-reported and radiographical outcomes of SMR Stemless Reverse Shoulder Arthroplasty. There is a retrospective and prospective study population.
The follow up time-points are (as of standard of care and not different for this study):
- Baseline
- 6 weeks postop
- 6 months postop
- 12 months postop
- 24 months postop
Study design
- Observational model
- Cohort
- Time perspective
- Other
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- There is a retrospective and prospective study population. All participants are older than 18 years old and approved the written informed consent. Additionally they are suffering from rotator-cuff arthropathy and/or osteoarthritis.
Key inclusion criteria (2 listed)
- rotator-cuff arthropathy, osteoarthritis
- approving written informed consent
Key exclusion criteria (3 listed)
- Female patients who are pregnant, nursing, or planning a pregnancy.
- All adult patients with any of the SMR Stemless contraindication for use for the reverse configuration as reported in the current local Instruction for use.
- not consenting in participating in this study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Subjective Shoulder Value score
Time frame: 5 years
Evaluation of the change of the Subjective Shoulder Value score from pre-operative to the last follow-up visit.
5 secondary outcomes
ASES Shoulder Score
Time frame: 5 years
Quick-Dash score
Time frame: 5 years
VAS pain
Time frame: 5 years
UCLA shoulder score
Time frame: 5 years
Loosening, implant stability, radiolucent lines
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 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.
Claudio Rosso, Prof. Dr. med. principal investigator
Arthro Medics AG
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 Rotator Cuff Tear Arthropathy and Osteo Arthritis Shoulders, run by Arthro Medics AG at 1 site in Switzerland.
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 2 inclusion and 3 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 31 Jul 2024. 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 Switzerland. 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 Claudio Rosso, PD Dr. med (+41 61 301 26 26, c.rosso@arthro.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Subjective Shoulder Value score (time frame: 5 years). 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 31 Jul 2024.