TESS V3 Modular Total Shoulder System PMCF
NCT05002959 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 67
Last updated 2025-09-08
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
Interventions
- DEVICE
-
Anatomic TESS V3
Implantation of the T.E.S.S.® V3 Modular Total Shoulder System, Anatomic configuration.
- DEVICE
-
Reverse TESS V3
Implantation of the T.E.S.S.® V3 Modular Total Shoulder System, Reverse configuration.
Sponsors & Collaborators
-
Zimmer Biomet
lead INDUSTRY
Principal Investigators
-
Emilie Rohmer · Zimmer Biomet
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-02-01
- Primary Completion
- 2026-10-31
- Completion
- 2026-12-31
Countries
- France
Study Locations
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