Shoulder ProsthesisMSSNCT04431973
Open-label, Prospective, Multicenter, Post-market Study to Evaluate the Reverse Medacta Shoulder System of Total Shoulder Prosthesis.
A study testing Medacta Shoulder System in people with Shoulder Prosthesis, run by University Hospital, Tours at 5 sites in France.
Trial summary
The goal of this study is to evaluate the performance of the Medacta Shoulder System total reverse shoulder prosthesis, at 2 years of follow up, in patients who required this prosthesis for primary omarthrosis, cuff tear arthropathy, massive cuff tear or post instability arthropathy. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Shoulder Prosthesis
- What is being tested?
- Medacta Shoulder System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 5 sitesFrance
- Study dates
- 1 Sep 2020to 1 Jul 2027
- Phase
- Interventional
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient aged 18 to 87 ;
- Patient with one of the following diseases: primary omarthrosis, cuff tear arthropathy, massive cuff tear or post instability arthropathy;
- Patient in need of a total shoulder prosthesis;
- Patient affiliated with or beneficiary of a social security scheme;
- Patient who has given written informed consent for the study.
Who cannot join
- Patient with malignant diseases;
- Patient with known or suspected infections;
- Patient with neurological deficits that may affect shoulder function;
- Patient with known incompatibility or allergy to product materials;
- Patient with previous open shoulder surgery (fracture sequelae, plate or nail, revision ...), treated for fractures, or suffering from rheumatoid arthritis (this does not concern patients treated by arthroscopy, or bone block);
- Protected major patient;
Show all 12Show fewer
- Vulnerable person according to article L1121-6 of the Public Health Code;
- Pregnant or breastfeeding woman or woman of childbearing age;
- Impossibility to follow the consultation schedule planned in the study (planned move or mutation, etc...).
- Patient with malignant diseases on the day of surgery;
- Patient with known incompatibility or allergy to product materials on the day of surgery;
- Patient with known or suspected infections on the day of surgery.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
France5 sites
Chu Angers
Angers
Chu Rennes
Rennes
Clinique Mutualiste la Sagesse
Rennes
Polyclinique santé atlantique
Saint-Herblain
Chu Tours
Tours
About this study
Official title: Étude Post-marché, Prospective, Multicentrique, Ouverte, d'évaluation de la prothèse Totale d'épaule inversée Medacta Shoulder System.
The goal of this study is to evaluate the performance of the Medacta Shoulder System total reverse shoulder prosthesis, at 2 years of follow up, in patients who required this prosthesis for primary omarthrosis, cuff tear arthropathy, massive cuff tear or post instability arthropathy.
The main goal is to evaluate at 2 years post-operatively the shoulder function of patients. The secondary goals are to assess the rate of complications, the survival rate of Reverse Medacta Shoulder System, the positioning of the prosthesis,pthe behaviour of the bone in contact with the humeral stem, Patient satisfaction and evolution of shoulder function in patients at 3 months and 1 year post-surgery.
Read the detailed description
This study is a prospective, national, multicenter, non-controlled, non-randomized study in order to evaluate outcomes of the MSS reverse prosthesis used for the management of primary osteoarthritis, cuff tear arthropathy, massive cuff tear, or post-instability arthroplasty.
Included patients, will have an oral and written information about the study, including the information note, during a preoperative visit. The surgeon will answer any questions that may arise and will collect their decision after sufficient time for the patient to reflect.
Patients participating in the research will be able to withdraw their consent and ask to stop the study at any time and for any reason. The investigator should document the reasons as fully as possible.
Patients will be followed according to the schedule below:
- V1 : Inclusion during a preoperative visit
- V2: Surgery maximum 4 months after inclusion
- V3: Follow-up visit at 3 months ± 1 month post-surgery
- V4: Follow-up visit at 12 months ± 2 months post-surgery
- V5: Follow-up visit between 24 months and 28 months post-surgery, marking the end of follow-up for the patient.
The surgical technique for implantation of the Reverse Medacta Shoulder System total shoulder prosthesis will be performed according to the MyShoulder pre-operative planning (without custom-made guides). All procedures will be performed with conventional instrumentation according to each surgeon's current practice. It is possible to use the BIO-RSA technique to reposition the pre-morbid glenoid center. The stem that will be used is the short stem (cementless) with PE angulation at 145°.
The following data will be collected at each of the 3 month, 1 year and 2 year :
- Post-operative complications as dislocation, glenoid loosening, infection, neurological damage, fracture.
- Survival of implants according to these definitions Revision: A procedure that removes all or part of the original configuration of the implant, one or more of the components except for the polyethylene insert* if it has been removed and restored Re-operation: Any surgical procedure that does not remove, modify or add any components to the system.
- Clinical examination: evaluation of post-operative mobility, Constant score. This examination corresponds to current practice.
- Medical Imaging: the results of the radiological examinations will be reviewed centrally by independent assessors. These evaluators will collect the available data from the radiographs of the AP view, axillary profile, or Neer/Lamy. The data from the scans will be analyzed by each investigator and by the software.
- Patient questionnaire If a follow-up visit is not made, the reason will be collected and noted in the patient record and on the CRF. The investigator will proceed to obtain the most exhaustive follow-up data possible
- The clinical examination will be replaced by the Self-Constant Questionnaire which will be sent to the patient for completion.
- The results of available radiological examinations will be collected.
- The patient questionnaires planned for the study (ISS score and OSS score) will be sent to the patient for completion.
A web-based data collection medium will be used for this study. All the information required by the protocol will be collected in a e-crf. It requires only an Internet connection and a browser. A help document for the use of this tool will be provided to the investigators.
Data management for the study will be handled by a CIC INSERM 1415 data-manager. The electronic case report form (eCRF) will be developed using Ennov Clinical® software. Data management will be done according to the standard operating procedures (edited in CIC INSERM 1415. The Clinical Research Assistant in charge of the study will be trained in the use of the eCRF, then will be in charge of the training of investigators. Data relating to post-operative radiological data will be entered on the eCRF directly by the independent assessors commissioned for the centralized review of radiological examinations.
Analyses will be performed with SAS Version 9.4 (or later). The statistical analysis will be performed according to a pre-established statistical analysis plan. Missing values will not be replaced by estimated values but will be considered as missing in the statistical analysis.
A statistical analysis report will be written integrating all the elements to be reported.
A clinical research assistant will ensure the rigourous conduct of the study, the collection of the data generated in writing, their documentation, recording and reporting, in accordance with the Promotion and Quality Control Unit of the Tours CHRU as well as the legal and regulatory provisions.
- Conditions
- Shoulder Prosthesis
- Being tested
- Medacta Shoulder System
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medacta Shoulder SystemDevice
Surgical placement of the Medacta Shoulder System prothesis on patients with pathologies requiring the insertion of a total reverse shoulder prothesis for primary omarthrosis, cuff tear arthropathy, massive cuff rupture or post instability arthropathy
| Study group | Role | What they receive |
|---|---|---|
| Shoulder prothesis | Experimental | Evaluate the performance of the Medacta Shoulder System total reverse shoulder prothesis Receives: Device: Medacta Shoulder System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Shoulder function by evaluation of Constant's Score
The main evaluation criteria is the rate of improvement of the Constant Score and preoperative and postoperative mobility (active external and internal rotation, elbow to body) at 2 years post surgery.
Measured: 2 years post surgery
Secondary outcomes (7)
Complication rate
Assess the complication rate associated with the MSS prosthesis (safety of the prosthesis, safety of the prosthesis, etc.).
Measured: At 2 years post surgery
Survival implants
Evaluate the survival of Reverse Medacta Shoulder System implants
Measured: At 2 years post surgery
Position of the prosthesis
Evaluate the positioning of the prosthesis by radiological analysis
Measured: At 3 months, 1 year and 2 years post-surgery.
Bone behaviour
Evaluation of bone behaviour in contact with the humeral stem
Measured: At 3 months, 1 year and 2 years post-surgery.
Subjective Shoulder Value
Assess patient satisfaction after surgery at 3 months, 1 year and 2 years post-surgery
Measured: At 3 months, 1 year and 2 years post-surgery
Oxford Shoulder Score
Assess patient satisfaction after surgery at 3 months, 1 year and 2 years post-surgery
Measured: At 3 months, 1 year and 2 years post-surgery
Shoulder function by evaluation of Constant's Score
Evaluate the evolution of shoulder function in patients who received a Medacta Shoulder System reverse ETP with MyShoulder preoperative planning (without custom guides).
Measured: At 3 months and 1 year post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2020
- Study start1 Sep 2020
- Primary completion1 Jul 2027 (estimated)
- Study completion1 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Shoulder ProsthesisStudies 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Tours
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04431973
- Sponsor's protocol ID
- DR190289-MSS
- Other IDs
- 2019-A03228-49
- Acronym
- MSS
- Status last verified
- Nov 2025
- First submitted
- 13 May 2020
- Last updated
- 24 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Étude Post-marché, Prospective, Multicentrique, Ouverte, d'évaluation de la prothèse Totale d'épaule inversée Medacta Shoulder System.
- ClinicalTrials.gov ID
- NCT04431973
- Acronym / sponsor ID
- MSS / DR190289-MSS
- Conditions
- Shoulder Prosthesis
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University Hospital, ToursUniversity, hospital or other
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 1 Jul 2027 (estimated)
- Study completion
- 1 Jul 2027 (estimated)
- First posted
- 16 Jun 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 goal of this study is to evaluate the performance of the Medacta Shoulder System total reverse shoulder prosthesis, at 2 years of follow up, in patients who required this prosthesis for primary omarthrosis, cuff tear arthropathy, massive cuff tear or post instability arthropathy.
The main goal is to evaluate at 2 years post-operatively the shoulder function of patients. The secondary goals are to assess the rate of complications, the survival rate of Reverse Medacta Shoulder System, the positioning of the prosthesis,pthe behaviour of the bone in contact with the humeral stem, Patient satisfaction and evolution of shoulder function in patients at 3 months and 1 year post-surgery.
Detailed description
This study is a prospective, national, multicenter, non-controlled, non-randomized study in order to evaluate outcomes of the MSS reverse prosthesis used for the management of primary osteoarthritis, cuff tear arthropathy, massive cuff tear, or post-instability arthroplasty.
Included patients, will have an oral and written information about the study, including the information note, during a preoperative visit. The surgeon will answer any questions that may arise and will collect their decision after sufficient time for the patient to reflect.
Patients participating in the research will be able to withdraw their consent and ask to stop the study at any time and for any reason. The investigator should document the reasons as fully as possible.
Patients will be followed according to the schedule below:
- V1 : Inclusion during a preoperative visit
- V2: Surgery maximum 4 months after inclusion
- V3: Follow-up visit at 3 months ± 1 month post-surgery
- V4: Follow-up visit at 12 months ± 2 months post-surgery
- V5: Follow-up visit between 24 months and 28 months post-surgery, marking the end of follow-up for the patient.
The surgical technique for implantation of the Reverse Medacta Shoulder System total shoulder prosthesis will be performed according to the MyShoulder pre-operative planning (without custom-made guides). All procedures will be performed with conventional instrumentation according to each surgeon's current practice. It is possible to use the BIO-RSA technique to reposition the pre-morbid glenoid center. The stem that will be used is the short stem (cementless) with PE angulation at 145°.
The following data will be collected at each of the 3 month, 1 year and 2 year :
- Post-operative complications as dislocation, glenoid loosening, infection, neurological damage, fracture.
- Survival of implants according to these definitions Revision: A procedure that removes all or part of the original configuration of the implant, one or more of the components except for the polyethylene insert* if it has been removed and restored Re-operation: Any surgical procedure that does not remove, modify or add any components to the system.
- Clinical examination: evaluation of post-operative mobility, Constant score. This examination corresponds to current practice.
- Medical Imaging: the results of the radiological examinations will be reviewed centrally by independent assessors. These evaluators will collect the available data from the radiographs of the AP view, axillary profile, or Neer/Lamy. The data from the scans will be analyzed by each investigator and by the software.
- Patient questionnaire If a follow-up visit is not made, the reason will be collected and noted in the patient record and on the CRF. The investigator will proceed to obtain the most exhaustive follow-up data possible
- The clinical examination will be replaced by the Self-Constant Questionnaire which will be sent to the patient for completion.
- The results of available radiological examinations will be collected.
- The patient questionnaires planned for the study (ISS score and OSS score) will be sent to the patient for completion.
A web-based data collection medium will be used for this study. All the information required by the protocol will be collected in a e-crf. It requires only an Internet connection and a browser. A help document for the use of this tool will be provided to the investigators.
Data management for the study will be handled by a CIC INSERM 1415 data-manager. The electronic case report form (eCRF) will be developed using Ennov Clinical® software. Data management will be done according to the standard operating procedures (edited in CIC INSERM 1415. The Clinical Research Assistant in charge of the study will be trained in the use of the eCRF, then will be in charge of the training of investigators. Data relating to post-operative radiological data will be entered on the eCRF directly by the independent assessors commissioned for the centralized review of radiological examinations.
Analyses will be performed with SAS Version 9.4 (or later). The statistical analysis will be performed according to a pre-established statistical analysis plan. Missing values will not be replaced by estimated values but will be considered as missing in the statistical analysis.
A statistical analysis report will be written integrating all the elements to be reported.
A clinical research assistant will ensure the rigourous conduct of the study, the collection of the data generated in writing, their documentation, recording and reporting, in accordance with the Promotion and Quality Control Unit of the Tours CHRU as well as the legal and regulatory provisions.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Shoulder prothesis | Experimental | Device: Medacta Shoulder SystemEvaluate the performance of the Medacta Shoulder System total reverse shoulder prothesis |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patient aged 18 to 87 ;
- Patient with one of the following diseases: primary omarthrosis, cuff tear arthropathy, massive cuff tear or post instability arthropathy;
- Patient in need of a total shoulder prosthesis;
- Patient affiliated with or beneficiary of a social security scheme;
- Patient who has given written informed consent for the study.
Key exclusion criteria (12 listed)
- Patient with malignant diseases;
- Patient with known or suspected infections;
- Patient with neurological deficits that may affect shoulder function;
- Patient with known incompatibility or allergy to product materials;
- Patient with previous open shoulder surgery (fracture sequelae, plate or nail, revision ...), treated for fractures, or suffering from rheumatoid arthritis (this does not concern patients treated by arthroscopy, or bone block);
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 |
|---|---|---|
| Medacta Shoulder SystemSurgical placement of the Medacta Shoulder System prothesis on patients with pathologies requiring the insertion of a total reverse shoulder prothesis for primary omarthrosis, cuff tear arthropathy, massive cuff rupture or post instability arthropathy | Device | Shoulder prothesis |
Primary outcome
Shoulder function by evaluation of Constant's Score
Time frame: 2 years post surgery
The main evaluation criteria is the rate of improvement of the Constant Score and preoperative and postoperative mobility (active external and internal rotation, elbow to body) at 2 years post surgery.
7 secondary outcomes
Complication rate
Time frame: At 2 years post surgery
Survival implants
Time frame: At 2 years post surgery
Position of the prosthesis
Time frame: At 3 months, 1 year and 2 years post-surgery.
Bone behaviour
Time frame: At 3 months, 1 year and 2 years post-surgery.
Subjective Shoulder Value
Time frame: At 3 months, 1 year and 2 years post-surgery
Oxford Shoulder Score
Time frame: At 3 months, 1 year and 2 years post-surgery
Shoulder function by evaluation of Constant's Score
Time frame: At 3 months and 1 year post-surgery
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 24 Nov 2025.
Related trials for Shoulder Prosthesis
Not yet recruitingObservational study
Three Year Outcomes After Shoulder Arthroplasty
Arthroplasty, Replacement, Shoulder, Arthritis Shoulder
Active, not recruitingObservational study
Database Retrieval for the Comprehensive Shoulder
Osteoarthritis of the Shoulder, Avascular Necrosis
Active, not recruiting
Post-Market Study of Comprehensive Reverse Augmented Glenoid and Mini Humeral Tray in Total Shoulder Arthroplasty
Arthropathy of Shoulder Region, Grossly Deficient Rotator Cuff
Recruiting
Prosthesis Versus Active Exercise Program in Patients With Rotator Cuff Arthropathy
Rotator Cuff Arthropathy
RecruitingObservational study
Post-Market Clinical Follow-Up (PMCF) Study Evaluating the Safety and Efficacy of Tıpmed™ Shoulder Prosthesis System
Glenohumeral Osteoarthritis, Proximal Humerus Fracture
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.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Medacta Shoulder System in people with Shoulder Prosthesis, run by University Hospital, Tours at 5 sites in France.
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 5 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: under way, not looking for participants, as of the sponsor's last update on 24 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in France. 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?
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?
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?
Shoulder function by evaluation of Constant's Score (time frame: 2 years post surgery). 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 24 Nov 2025.