Osteoarthritis ShoulderNCT05002959
TESS V3 Modular Total Shoulder System PMCF
An observational study of Osteoarthritis Shoulder and Rheumatoid Arthritis, run by Zimmer Biomet at 2 sites in France.
Trial summary
This is a multicenter, retrospective and prospective, non-controlled post market surveillance study. The objectives of this study are to confirm safety, performance and clinical benefits of the T.E.S.S.® Version 3 Anatomic and Reverse Modular Total shoulder prosthesis and its instrumentation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteoarthritis Shoulder, Rheumatoid Arthritis, Rheumatoid Arthritis Shoulder
- What is being tested?
- Anatomic TESS V3 and Reverse TESS V3
- Type of treatment
- Medical device
- How many people
- 67 participants
- Where
- 2 sitesFrance
- Study dates
- 1 Feb 2022to 5 Mar 2026
- 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: Subjects who have received a T.E.S.S.® Version 3 Anatomic or Reverse shoulder prosthesis from January 2013, based on the Indications for Use and who meet all of the inclusion and none of exclusion criteria.
Who may be able to join
- Patient is 18 years or older and skeletally mature
- Patient is capable of understanding the surgeon's explanations and following his instructions, able and willing to participate in the follow-up program
- Patient gave consent to take part in the study by signing the Informed Consent Form
- Patient operated from January 2013 and received the Anatomic or Reverse T.E.S.S.® V3 Modular Total Shoulder System to relieve pain and restore the joint function
- Patient has adequate quality and quantity of bone stock to support the prosthesis
- Patient meets at least one of the following indications:
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- For anatomic type:
- Centered osteoarthritis of the shoulder
- Humeral head fractures
- Rheumatoid arthritis (with intact rotator cuff)
- Avascular necrosis of the humeral head
- Revision of a hemi-arthroplasty with a total arthroplasty
- Revision of a reverse prosthesis with an anatomic prosthesis
- Revision to increase the size of the stem (length and/or diameter)
- Revision of a glenoid prosthesis, a glenoid insert or a competitor's prosthesis
- For reverse type:
- Offset osteoarthritis of the shoulder
- Massive and non-repairable rotator cuff tears
- Rheumatoid arthritis (with degenerative rotator cuff)
- Revision of an anatomic prosthesis with a reverse prosthesis
- Revision to increase the size of the stem (length and/or diameter)
- Revision of a glenoid prosthesis, a glenoid insert or a competitor's prosthesis
Who cannot join
- Patient is unwilling or unable to give consent or to comply with the follow-up program
- Patient is known to be pregnant or breastfeeding
- Patient has any condition that would, in the judgment of the Investigator, place the patient at undue risk or interfere with the study
- Patient is a vulnerable subject (prisoner, mentally incompetent or unable to understand what participation to the study entails, a known alcohol or drug abuser, anticipated to be non-compliant)
- Patient who displays any of the following contra-indications cannot be included in this study:
- Local or systemic infections
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- Severe muscular, neurological, or vascular deficiency of the affected joint
- Poor bone quality likely to prevent osseointegration or to affect the long-term stability of the implant (Paget's disease, osteoporosis)
- Any concomitant conditions likely to affect the function of the implant
- Allergy to any of the implant components
- Do not use the modular humeral version (screwed connection) in cases where the corolla cannot be two-thirds covered with bone stock and including the screwed modular stem/corolla junction
Trial locations and contacts
2 sites in 1 country.
France2 sites
Lyon Ortho Clinic
Lyon
Clinique Saint-Jean (Group ORTHOSUD)
Saint-Jean-de-Védas
About this study
Official title: Retrospective and Prospective, Multicenter Study on T.E.S.S.® V3 (Implants and Instrumentation)
This is a multicenter, retrospective and prospective, non-controlled post market surveillance study. The objectives of this study are to confirm safety, performance and clinical benefits of the T.E.S.S.® Version 3 Anatomic and Reverse Modular Total shoulder prosthesis and its instrumentation.
Read the detailed description
The T.E.S.S.® (Total Evolutive Shoulder System) was developed to provide, with one instrumentation, a complete solution for all indications for shoulder arthroplasty: centered and eccentric rheumatoid osteoarthritis, necrosis, proximal fracture and mal-union of the humeral head. The T.E.S.S.® Modular system can be used in anatomic or reverse configurations with or without the use of a stem, providing a solution for hemi-arthroplasty, total shoulder arthroplasty and revision. The same instrumentation allows implantation of all versions of the T.E.S.S.®.
A maximum of 5 study centers will be involved in Europe. A total number of 146 implants, 73 T.E.S.S.® anatomic and 73 T.E.S.S.® reverse, will be included into the study. Each clinical site will be allowed to enroll a maximum 88 patients (60% of the total study cohort). Ethics Committee (EC) approval has to be obtained prior to conducting this study. All potential subjects will be required to participate in an informed consent process and sign the EC approved written informed consent prior to study enrollment.
- Conditions
- Osteoarthritis Shoulder, Rheumatoid Arthritis, Rheumatoid Arthritis Shoulder, Avascular Necrosis, Revision, Rotator Cuff Tears
- Being tested
- Anatomic TESS V3, Reverse TESS V3
- Keywords
- Shoulder arthroplasty, Medical device, Performance, Safety, Shoulder prosthesis
- Medical subject headings
- Arthritis, Rheumatoid, Osteonecrosis, Rotator Cuff Injuries, Rotator Cuff Tear Arthropathy, Shoulder Fractures, Fractures, Malunited
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anatomic TESS V3Device
Implantation of the T.E.S.S.® V3 Modular Total Shoulder System, Anatomic configuration.
Reverse TESS V3Device
Implantation of the T.E.S.S.® V3 Modular Total Shoulder System, Reverse configuration.
| Study group | Role | What they receive |
|---|---|---|
| TESS Anatomic | Subjects who received the Anatomic T.E.S.S.® V3 Modular Total Shoulder System to relieve pain and restore the joint function and who met the inclusion/exclusion criteria. Receives: Device: Anatomic TESS V3 | |
| TESS Reverse | Subjects who received the Reverse T.E.S.S.® V3 Modular Total Shoulder System to relieve pain and restore the joint function and who met the inclusion/exclusion criteria. Receives: Device: Reverse TESS V3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Implant survival at 10 years
The functional performance and clinical benefits will be determined by assessing the survival of the implant at 10 years using the Kaplan-Meier method. The survivorship of the implanted device will be recorded from the date of implantation to the date of revision or intended revision up to 10 years post-operatively.
Measured: 10 years
Frequency and incidence of adverse events
The safety will be assessed by monitoring the frequency and incidence of adverse events.
Adverse events will be collected in an Adverse Event Form, which gathers information on the date of occurrence, the nature of the adverse event, whether the device was involved, which treatment was used and the treatment outcome.
Measured: 10 years
Secondary outcomes (3)
Constant and Murley score
The functional performance and clinical benefits will be assessed by the Constant and Murley score.
The Constant Murley score 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 test is divided into four subscales: pain (15 points), activities of daily living (20 points), strength (25 points) and range of motion: forward elevation, external rotation, abduction and internal rotation of the shoulder (40 points). The higher the score, the higher the quality of the function.
Measured: 10 years
EQ-5D-5L questionnaire
The functional performance and clinical benefits will be evaluated by collecting the patient-filled EQ-5D-5L questionnaire.
EQ-5D-5L is a standardized instrument for measuring the health-related quality of life, which assesses health status in terms of five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each question has five levels of response (no problems, slight problems, moderate problems, severe problems, extreme problems/unable to), which are singularly rated and then combined into a health status score, with higher scores indicating higher health utility. The second part of the EQ-5D-5L questionnaire consists of a visual analogue scale (VAS) on which the patient rates his/her perceived health from 0 (the worst imaginable health) to 100 (the best imaginable health).
Measured: 10 years
Radiographic Evaluation
The functional performance and clinical benefit will be evaluated by analyzing the post-operative radiographic parameters (radiolucency, osteolysis, osteophytes, component migration and heterotopic ossification). At each post-operative follow-up visit, the radiographies will be evaluated and any finding will be collected in a Radiographic Evaluation Form.
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2021
- Study start1 Feb 2022
- Primary completion5 Mar 2026
- Study completion5 Mar 2026
Why it stopped: Termination of PMCF study due to product discontinuation (commercial reasons)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis ShoulderStudies of the same condition, open and under way.
- More trials run by Zimmer BiometThe 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
- Other
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zimmer Biomet
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Emilie Rohmer, Study director, Zimmer Biomet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05002959
- Sponsor's protocol ID
- CME2019-44E
- Status last verified
- Jun 2026
- First submitted
- 5 Aug 2021
- Last updated
- 9 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective and Prospective, Multicenter Study on T.E.S.S.® V3 (Implants and Instrumentation)
- ClinicalTrials.gov ID
- NCT05002959
- Acronym / sponsor ID
- CME2019-44E
- Conditions
- Osteoarthritis Shoulder, Rheumatoid Arthritis, Rheumatoid Arthritis Shoulder, Avascular Necrosis, Revision, Rotator Cuff Tears
- Keywords
- Shoulder arthroplasty, Medical device, Performance, Safety, Shoulder prosthesis
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Termination of PMCF study due to product discontinuation (commercial reasons)
- Enrolment
- 67 participants (actual)
- Lead sponsor
- Zimmer BiometIndustry (pharma, biotech, devices)
- Study start
- 1 Feb 2022 (actual)
- Primary completion
- 5 Mar 2026 (actual)
- Study completion
- 5 Mar 2026 (actual)
- First posted
- 12 Aug 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.
This is a multicenter, retrospective and prospective, non-controlled post market surveillance study. The objectives of this study are to confirm safety, performance and clinical benefits of the T.E.S.S.® Version 3 Anatomic and Reverse Modular Total shoulder prosthesis and its instrumentation.
Detailed description
The T.E.S.S.® (Total Evolutive Shoulder System) was developed to provide, with one instrumentation, a complete solution for all indications for shoulder arthroplasty: centered and eccentric rheumatoid osteoarthritis, necrosis, proximal fracture and mal-union of the humeral head. The T.E.S.S.® Modular system can be used in anatomic or reverse configurations with or without the use of a stem, providing a solution for hemi-arthroplasty, total shoulder arthroplasty and revision. The same instrumentation allows implantation of all versions of the T.E.S.S.®.
A maximum of 5 study centers will be involved in Europe. A total number of 146 implants, 73 T.E.S.S.® anatomic and 73 T.E.S.S.® reverse, will be included into the study. Each clinical site will be allowed to enroll a maximum 88 patients (60% of the total study cohort). Ethics Committee (EC) approval has to be obtained prior to conducting this study. All potential subjects will be required to participate in an informed consent process and sign the EC approved written informed consent prior to study enrollment.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TESS Anatomic | – | Device: Anatomic TESS V3Subjects who received the Anatomic T.E.S.S.® V3 Modular Total Shoulder System to relieve pain and restore the joint function and who met the inclusion/exclusion criteria. |
| TESS Reverse | – | Device: Reverse TESS V3Subjects who received the Reverse T.E.S.S.® V3 Modular Total Shoulder System to relieve pain and restore the joint function and who met the inclusion/exclusion criteria. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects who have received a T.E.S.S.® Version 3 Anatomic or Reverse shoulder prosthesis from January 2013, based on the Indications for Use and who meet all of the inclusion and none of exclusion criteria.
Key inclusion criteria (22 listed)
- Patient is 18 years or older and skeletally mature
- Patient is capable of understanding the surgeon's explanations and following his instructions, able and willing to participate in the follow-up program
- Patient gave consent to take part in the study by signing the Informed Consent Form
- Patient operated from January 2013 and received the Anatomic or Reverse T.E.S.S.® V3 Modular Total Shoulder System to relieve pain and restore the joint function
- Patient has adequate quality and quantity of bone stock to support the prosthesis
Key exclusion criteria (11 listed)
- Patient is unwilling or unable to give consent or to comply with the follow-up program
- Patient is known to be pregnant or breastfeeding
- Patient has any condition that would, in the judgment of the Investigator, place the patient at undue risk or interfere with the study
- Patient is a vulnerable subject (prisoner, mentally incompetent or unable to understand what participation to the study entails, a known alcohol or drug abuser, anticipated to be non-compliant)
- Patient who displays any of the following contra-indications cannot be included 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.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Anatomic TESS V3Implantation of the T.E.S.S.® V3 Modular Total Shoulder System, Anatomic configuration. | Device | TESS Anatomic |
| Reverse TESS V3Implantation of the T.E.S.S.® V3 Modular Total Shoulder System, Reverse configuration. | Device | TESS Reverse |
Primary outcome
Implant survival at 10 years
Time frame: 10 years
The functional performance and clinical benefits will be determined by assessing the survival of the implant at 10 years using the Kaplan-Meier method. The survivorship of the implanted device will be recorded from the date of implantation to the date of revision or intended revision up to 10 years post-operatively.
Frequency and incidence of adverse events
Time frame: 10 years
The safety will be assessed by monitoring the frequency and incidence of adverse events. Adverse events will be collected in an Adverse Event Form, which gathers information on the date of occurrence, the nature of the adverse event, whether the device was involved, which treatment was used and the treatment outcome.
3 secondary outcomes
Constant and Murley score
Time frame: 10 years
EQ-5D-5L questionnaire
Time frame: 10 years
Radiographic Evaluation
Time frame: 10 years
Results and safety
The study was stopped early (reason given: Termination of PMCF study due to product discontinuation (commercial reasons)). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2026.
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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.
Emilie Rohmer study director
Zimmer Biomet
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Osteoarthritis Shoulder and Rheumatoid Arthritis, run by Zimmer Biomet at 2 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 22 inclusion and 11 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: stopped early, as of the sponsor's last update on 9 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 2 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?
The study was stopped early (reason given: Termination of PMCF study due to product discontinuation (commercial reasons)). Results are not available in the source record.
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?
Implant survival at 10 years (time frame: 10 years). 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 9 Jun 2026.