Multi Centre Study on TESS V2 Shoulder System

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Zimmer Biomet

Status

Completed

Conditions

Rotator Cuff Tear
Fracture
Osteoarthritis Shoulder
Revision
Avascular Necrosis
Rheumatoid Arthritis

Treatments

Device: TESS V2

Study type

Observational

Funder types

Industry

Identifiers

NCT03431857
ORTHO.CR.E13

Details and patient eligibility

About

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.

Full 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.

Enrollment

106 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Additional inclusion criteria include

  • 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

Trial design

106 participants in 1 patient group

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

Trial documents
1

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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