TESS V3 Modular Total Shoulder System PMCF

Last updated: March 19, 2025
Sponsor: Zimmer Biomet
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Rheumatoid Arthritis

Arthritis And Arthritic Pain

Osteomyelitis

Treatment

Anatomic TESS V3

Reverse TESS V3

Clinical Study ID

NCT05002959
CME2019-44E
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patient is 18 years or older and skeletally mature

  • Patient is capable of understanding the surgeon's explanations and following hisinstructions, 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.® V3Modular 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

Exclusion Criteria:

  • Patient is unwilling or unable to give consent or to comply with the follow-upprogram

  • Patient is known to be pregnant or breastfeeding

  • Patient has any condition that would, in the judgment of the Investigator, place thepatient at undue risk or interfere with the study

  • Patient is a vulnerable subject (prisoner, mentally incompetent or unable tounderstand 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 inthis 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-termstability 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 thecorolla cannot be two-thirds covered with bone stock and including the screwedmodular stem/corolla junction

Study Design

Total Participants: 67
Treatment Group(s): 2
Primary Treatment: Anatomic TESS V3
Phase:
Study Start date:
February 01, 2022
Estimated Completion Date:
December 31, 2026

Study Description

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.

Connect with a study center

  • Lyon Ortho Clinic

    Lyon,
    France

    Site Not Available

  • Clinique Saint-Jean (Group ORTHOSUD)

    Saint Jean de Védas,
    France

    Site Not Available

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