NCT03431857

Multi Centre Study on TESS V2 Shoulder System

Retrospective and Prospective, Multi Centre Study on T.E.S.S® V2 Shoulder System

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 106 (actual)
• Sponsor: Zimmer Biomet · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is a Post Market Clinical Follow-up study to fulfill the post market surveillance requirements. The data collected from this study will serve the purpose of confirming safety and performance of the TESS Shoulder System.

Detailed description

The objective of this retrospective and prospective, multicenter, non-controlled Post Market Clinical Follow-up study is to evaluate the mid-term (5-year) clinical performance of the TESS Version 2 Anatomic and Reverse prostheses in shoulder arthroplasty. The primary outcome is defined as the clinical performance determined using Constant Score. The secondary outcomes are the passive and active mobility, the radiographic evaluation, the complications (including dislocation and revisions/removals) and survivorship.

Conditions

• Osteoarthritis Shoulder
• Fracture
• Rheumatoid Arthritis
• Avascular Necrosis
• Rotator Cuff Tear
• Revision

Interventions

Type	Name	Description
DEVICE	TESS V2	Patients requiring the TESS V2 prosthesis.

Timeline

• Start date: 2010-10-20
• Primary completion: 2015-12-31
• Completion: 2019-12-31
• First posted: 2018-02-13
• Last updated: 2021-10-19
• Results posted: 2021-10-19

Locations

2 sites across 2 countries: Belgium, France