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Multi Centre Study on TESS V2 Shoulder System

NCT ID: NCT03431857

Last Updated: 2021-10-19

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

106 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-10-20

Study Completion Date

2019-12-31

Brief Summary

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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

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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

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Osteoarthritis Shoulder Fracture Rheumatoid Arthritis Avascular Necrosis Rotator Cuff Tear Revision

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Study Groups

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TESS V2 Prosthesis

Single study patient cohort, including 106 patients who meet the inclusion/exclusion criteria and who received the TESS V2 shoulder prosthesis.

TESS V2

Intervention Type DEVICE

Patients requiring the TESS V2 prosthesis.

Interventions

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TESS V2

Patients requiring the TESS V2 prosthesis.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Except in special cases, the "anatomic" type is indicated for:

* Centered osteoarthritis of the shoulder
* Humeral head fractures
* Rheumatoid arthritis (with intact rotator cuff)
* Avascular necrosis of the humeral head
* Except in special cases, the "reversed" type is indicated for:

* Offset osteoarthritis of the shoulder
* Massive and non-repairable rotator cuff tears
* Rheumatoid arthritis (with degenerative rotator cuff)
* Revision in cases of:

* Replacement of an "anatomic" prosthesis with a "reversed" prosthesis
* Conversion of a hemi-arthroplasty into a total arthroplasty
* Increasing the size of the stem (length and/or diameter)
* Replacing a glenoid prosthesis
* Replacing a competitor's prosthesis
* In rare cases, removing a "reversed" prosthesis and replacing it with an "anatomic" prosthesis

* Patient who read, understood study information and gave informed consent (oral or written depending on specific local regulatory requirements)
* Willing to return for follow-up evaluations

Exclusion Criteria

* Local or systemic infections.
* Severe muscular, neurological, or vascular deficiency of the affected joint.
* Bone destruction or poor bone quality liable to affect the stability of the implant (Paget's disease, osteoporosis, etc.)
* Cases where the corolla cannot be two-thirds covered with bone stock and including the stem/corolla junction.
* Any concomitant complaint likely to affect the functioning of the implant.
* Allergy to any of the implant components.
* Local bone tumors.
* Patient over 18 under law supervision
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Zimmer Biomet

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Paola Vivoda

Role: STUDY_DIRECTOR

Zimmer Biomet

Locations

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Orthokliniek Waasland

Sint-Niklaas, , Belgium

Site Status

Institut Calot

Berck, , France

Site Status

Countries

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Belgium France

Provided Documents

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Document Type: Study Protocol

View Document

Other Identifiers

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ORTHO.CR.E13

Identifier Type: -

Identifier Source: org_study_id