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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
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

Full criteria on ClinicalTrials.gov

Sites (2)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
Lyon Ortho ClinicLyonFranceUnknown status
Clinique Saint-Jean (Group ORTHOSUD)Saint-Jean-de-VédasFranceUnknown status

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This page is information, not medical advice. Discuss any trial with your doctor.