TESS V3 Modular Total Shoulder System PMCF

NCT05002959 | Active Not Recruiting

• 1 other identifier: CME2019-44E
• Study Type: observational
• Target: 67
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Osteoarthritis Shoulder; Rheumatoid Arthritis; Rheumatoid Arthritis Shoulder; Avascular Necrosis; Revision; Rotator Cuff Tears; Osteonecrosis; Rotator Cuff Tear Arthropathy; Proximal Humeral Fracture; Malunion of Fracture, Shoulder Region

Keywords

Shoulder arthroplasty; Medical device; Performance; Safety; Shoulder prosthesis

Outcome Measures

Primary Outcomes (2)

• Implant survival at 10 years

  The functional performance and clinical benefits will be determined by assessing the survival of the implant at 10 years using the Kaplan-Meier method. The survivorship of the implanted device will be recorded from the date of implantation to the date of revision or intended revision up to 10 years post-operatively.

  10 years

• Frequency and incidence of adverse events

  The safety will be assessed by monitoring the frequency and incidence of adverse events. Adverse events will be collected in an Adverse Event Form, which gathers information on the date of occurrence, the nature of the adverse event, whether the device was involved, which treatment was used and the treatment outcome.

  10 years

Secondary Outcomes (3)

• Constant and Murley score

  10 years

• EQ-5D-5L questionnaire

  10 years

• Radiographic Evaluation

  10 years

Study Arms (2)

TESS Anatomic

Subjects who received the Anatomic T.E.S.S.® V3 Modular Total Shoulder System to relieve pain and restore the joint function and who met the inclusion/exclusion criteria.

Device: Anatomic TESS V3

TESS Reverse

Subjects who received the Reverse T.E.S.S.® V3 Modular Total Shoulder System to relieve pain and restore the joint function and who met the inclusion/exclusion criteria.

Device: Reverse TESS V3

Interventions

Anatomic TESS V3 DEVICE

Implantation of the T.E.S.S.® V3 Modular Total Shoulder System, Anatomic configuration.

TESS Anatomic

Reverse TESS V3 DEVICE

Implantation of the T.E.S.S.® V3 Modular Total Shoulder System, Reverse configuration.

TESS Reverse

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Zimmer Biomet: lead

Study Sites (2)

Lyon Ortho Clinic

Lyon, France

Location

Clinique Saint-Jean (Group ORTHOSUD)

Saint-Jean-de-Védas, France

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid; Osteonecrosis; Rotator Cuff Injuries; Rotator Cuff Tear Arthropathy; Shoulder Fractures; Fractures, Malunited

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Bone Diseases; Necrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Rupture; Wounds and Injuries; Shoulder Injuries; Tendon Injuries; Chondrocalcinosis; Crystal Arthropathies; Fractures, Bone

Study Officials

• Emilie Rohmer

  Zimmer Biomet

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 5, 2021
• First Posted: August 12, 2021
• Study Start: February 1, 2022
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: September 8, 2025

Record last verified: 2025-08

Locations

FR (2)