NCT05002959Terminated
TESS V3 Modular Total Shoulder System PMCF
Retrospective and Prospective, Multicenter Study on T.E.S.S.® V3 (Implants and Instrumentation)
Source: ClinicalTrials.gov · Last updated 9 Jun 2026
Reason given: Termination of PMCF study due to product discontinuation (commercial reasons)
Brief summary (registry, in English)
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.
- Status (registry)
- Terminated
- Study type
- Observational
- Enrollment
- 67 (actual)
- First submitted
- 5 Aug 2021
- Start date
- 1 Feb 2022
- Primary completion date
- 5 Mar 2026
- Lead sponsor
- Zimmer Biomet
- Diseases
- Rheumatoid arthritis
- NCT number
- NCT05002959
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
- 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
Other illness
- Patient has any condition that would, in the judgment of the Investigator, place the patient at undue risk or interfere with the study
Other
- Patient is unwilling or unable to give consent or to comply with the follow-up program
- Patient is known to be pregnant or breastfeeding
Who the study is looking for
- 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:
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Lyon Ortho Clinic | Lyon | France | Unknown status |
| Clinique Saint-Jean (Group ORTHOSUD) | Saint-Jean-de-Védas | France | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.