Trials / Active Not Recruiting
Active Not RecruitingNCT05002959
TESS V3 Modular Total Shoulder System PMCF
Retrospective and Prospective, Multicenter Study on T.E.S.S.® V3 (Implants and Instrumentation)
- Status
- Active Not Recruiting
- Phase
- —
- Study type
- Observational
- Enrollment
- 67 (actual)
- Sponsor
- Zimmer Biomet · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Detailed 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.
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
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2022-02-01
- Primary completion
- 2026-10-01
- Completion
- 2026-12-01
- First posted
- 2021-08-12
- Last updated
- 2025-09-08
Locations
2 sites across 1 country: France
Source: ClinicalTrials.gov record NCT05002959. Inclusion in this directory is not an endorsement.