Shoulder implant under review: will it last 10 years?
NCT ID NCT05002959
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study looked at a shoulder implant used to treat pain and joint problems from conditions like arthritis, fractures, and rotator cuff tears. It involved 67 adults who received the implant and tracked how long it lasted and any side effects over 10 years. The goal was to confirm the implant is safe and works well.
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Study facts
What this study's own registry entry says, in plain language.
- Participants
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67 people
The number who actually took part.
- Started
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Feb 2022
- Finished
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Mar 2026
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
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.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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 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 * 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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Clinique Saint-Jean (Group ORTHOSUD)
Saint-Jean-de-Védas, France
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Lyon Ortho Clinic
Lyon, France
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Other studies related to the condition(s) this trial covers.
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