TESS V3 Modular Total Shoulder System PMCF (NCT05002959) | Clinical Trial Compass
TerminatedNot Applicable
TESS V3 Modular Total Shoulder System PMCF
Stopped: Termination of PMCF study due to product discontinuation (commercial reasons)
France67 participantsStarted 2022-02-01
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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
Exclusion Criteria:
* Patient is unwilling or …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial was terminated before it finished — does that mean there are unresolved safety or performance questions about the TESS V3 implant that I should be aware of before considering this type of shoulder replacement?
2Since the trial was measuring implant survival over 10 years and was cut short, how much long-term durability data actually exists for this specific modular shoulder system, and how does that compare to other implants my surgeon uses routinely?
3My condition is listed as one of the diagnoses this trial covered — given that the study didn't complete, is the TESS V3 device still being used in practice, and what does my doctor know about its track record in patients with my specific diagnosis?
4Because this was a post-market follow-up study rather than a randomized trial, what does 'Phase NA' mean for how much we can trust any safety or outcome findings that were collected before the study stopped?
5Are there other completed or ongoing studies on modular total shoulder systems that might give us better evidence to guide my decision, rather than relying on data from a terminated trial?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.