Retrospective and Prospective, Multi Centre Study on T.E.S.S® V2 Shoulder System
Conditions: Osteoarthritis Shoulder, Fracture, Rheumatoid Arthritis, Avascular Necrosis, Rotator Cuff Tear, Revision
Sponsor: Zimmer Biomet

T.E.S.S® VERSION 2 
 
2012-05-30- Rev. 2.0 
Protocol # ORTHO.CR.E13 
 
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T.E.S.S® VERSION 2 
Retrospective and Prospective, Multi centre Study on 
T.E.S.S® V2 Shoulder System 
 
PROTOCOL NO. ORTHO.CR.E13 
 
 
NCT NUMBER: NCT03431857 
 
 
 
PROTOCOL VERSION: 
2012-05-30 - REV. 2.0 
 
 
 
 
 
 
 
 
STUDY SPONSOR 
 
ZIMMER GMBH 
SULZERALLEE 8 
P.O. BOX 
CH-8404 WINTERTHUR 
SWITZERLAND 
 
 
 
 
 
 
 
 
 

T.E.S.S® VERSION 2 
 
2012-05-30- Rev. 2.0 
Protocol # ORTHO.CR.E13 
 
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Title: 
Retrospective and Prospective, Multi centre Study on T.E.S.S® V2 
Shoulder System 
Sponsor: 
Zimmer GmbH 
Objectives: 
The objective of this study is to evaluate mid-term (5-year) clinical 
performance of the T.E.S.S® Version 2 Anatomic and Reverse prostheses 
in shoulder arthroplasty. Patient and Shoulder function will be collected 
along with Constant Score, radiographic and survivorship data. 
Outcome 
Measures 
• 
Primary outcome: 
o 
Clinical efficacy using Constant Score 
• 
Other outcome measures 
o 
Passive and active mobility 
o 
Radiographic Evaluation 
o 
Complications (including dislocation and 
revisions/removals) 
o 
Survivorship. 
Indication/ 
Target Population: 
200 subjects suitable for T.E.S.S® Shoulder Replacement can be included 
into this study: 100 subjects in each subgroup 
Inclusion/Exclusion 
criteria 
Inclusion criteria 
The inclusion criteria are the same as the indications stated in the G-Med 
cleared labeling for 
the device. 
The range of T.E.S.S.® shoulder prostheses are indicated in the following 
cases: 
• 
Except in special cases, the "anatomic" type is indicated for: 
o 
Centered osteoarthritis of the shoulder 
o 
Humeral head fractures 
o 
Rheumatoid arthritis (with intact rotator cuff) 
o 
Avascular necrosis of the humeral head 
• 
Except in special cases, the "reversed" type is indicated for: 
o 
Offset osteoarthritis of the shoulder 
o 
Massive and non-repairable rotator cuff tears 
o 
Rheumatoid arthritis (with degenerative rotator cuff) 
• 
Revision in cases of: 
o 
Replacement of an "anatomic" prosthesis with a 
"reversed" prosthesis 
o 
Conversion of a hemi-arthroplasty into a total arthroplasty 
o 
Increasing the size of the stem (length and/or diameter) 
o 
Replacing a glenoid prosthesis 
o 
Replacing a competitor’s prosthesis 
o 
In rare cases, removing a "reversed" prosthesis and 
replacing it with an "anatomic" prosthesis 
Additional inclusion criteria include 
o 
Patient who read, understood study information and gave 
informed consent (oral or written depending on specific 
local regulatory requirements) 
 
Exclusion criteria 
The Exclusion criteria are the same as the indications stated in the G-Med 
cleared labeling for the device 

T.E.S.S® VERSION 2 
 
2012-05-30- Rev. 2.0 
Protocol # ORTHO.CR.E13 
 
Page 3 of 3 
 
Contraindications: 
Subjects displaying any of the following contra-indications shall be 
excluded from this evaluation: 
• 
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. 
Additional exclusion criteria include 
• 
Patient over 18 under law supervision 
Length of Study: 
The study assessment period will be 6,5 years: 18 months of recruitment 
and 5 years followup. The follow-up clinical reviews for all patients will be 
at discharge, 6 weeks, 6 months, 1 year, 2 years, 3 years, 4 years and 5 
years.