Multi Centre Study on TESS V2 Shoulder System

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