An observational study in Osteoarthritis Shoulder, Rheumatoid Arthritis and Rheumatoid Arthritis Shoulder, sponsored by Zimmer Biomet. Terminated at 2 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-09.
Sponsored by Zimmer Biomet · Observational
Among 59 studies in Arthritis, Rheumatoid by Zimmer Biomet — 4 open to participants now, 22 under way, none of them phase 3. Arthritis, Rheumatoid · Zimmer Biomet.
Among the 59 studies in Arthritis, Rheumatoid by Zimmer Biomet, this one is the 29th largest by enrollment of the 34 observational ones that give a count, is one of 2 that started in 2022, is one of 34 observational ones, and was the 53rd registered.
3,332 studies on the registry are indexed under Arthritis, Rheumatoid; 443 are open to participants now.
Browse Arthritis, Rheumatoid studies →4 of the 59 studies in Arthritis, Rheumatoid by Zimmer Biomet are open now, in 5 countries. Recruiting first, the newest first:
Zimmer Biomet · Sites in Japan
Zimmer Biomet · Sites in United States
Zimmer Biomet · Sites in United States, Belgium, Italy and 1 more country
Zimmer Biomet · Sites in United States
By country, each count listing its studies:
Of the 293 Arthritis, Rheumatoid studies recruiting now, 150 (51%) set no upper age limit and 109 (37%) stop at 75 or younger; 15 take children under 18; 36 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
59 studies; the count open now beside each. This study's row is marked.
First in 2004; this study’s year is marked. 2 started in 2022.
This study's enrollment of 67 is below the median of 176 across 1,016 observational studies indexed under Arthritis, Rheumatoid.
Median enrollment 148 across the 25 interventional studies, 156 across the 34 observational. Of the 33 that completed or were terminated, 18 (55%) have results posted.
This tab as a report to print or save as PDF → With an account.
Zimmer Biomet is the lead sponsor of 275 studies on the registry; 28 are open to participants now.
Of its 22 completed or terminated interventional studies of FDA-regulated products, 19 (86%) have results posted.
6 of the studies in Arthritis, Rheumatoid by Zimmer Biomet that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT03409718Zimmer BiometDatabase Retrieval for the Comprehensive Shoulder | 2026-12 |
| NCT01480440Zimmer BiometOutcomes Study of the Trabecular Metal (TM) Reverse Shoulder System | 2026-12 |
| NCT03626038Zimmer BiometPost Market Clinical Follow-up (PMCF) Study of the A.L.P.S. Proximal Humerus Plating System | 2026-12 |
| NCT03404778Zimmer BiometComprehensive Reverse Shoulder Data Collection | 2026-12 |
| NCT05966519Zimmer BiometROSA Knee Intraoperative Planning Flexibility Study | 2027-01 |
Among the 59 studies in Arthritis, Rheumatoid by Zimmer Biomet, from their registry updates:
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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.
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.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
For anatomic type:
For reverse type:
Exclusion Criteria:
Patient who displays any of the following cannot be included in this study:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Device: Anatomic TESS V3
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.
Device: Reverse TESS V3
Implantation of the T.E.S.S.® V3 Modular Total Shoulder System, Anatomic configuration.
Implantation of the T.E.S.S.® V3 Modular Total Shoulder System, Reverse configuration.
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.
Time frame: 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.
Time frame: 10 years
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.
Time frame: 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).
Time frame: 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.
Time frame: 10 years
Ran from Feb 2022 to primary completion in Mar 2026, 49 months.
How these figures are worked out, and which studies are left out of them.
This study is terminated, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.
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