Phase
Condition
Rheumatoid Arthritis
Arthritis And Arthritic Pain
Osteomyelitis
Treatment
Anatomic TESS V3
Reverse TESS V3
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Patient is 18 years or older and skeletally mature
Patient is capable of understanding the surgeon's explanations and following hisinstructions, able and willing to participate in the follow-up program
Patient gave consent to take part in the study by signing the Informed Consent Form
Patient operated from January 2013 and received the Anatomic or Reverse T.E.S.S.® V3Modular Total Shoulder System to relieve pain and restore the joint function
Patient has adequate quality and quantity of bone stock to support the prosthesis
Patient meets at least one of the following indications:
For anatomic type:
Centered osteoarthritis of the shoulder
Humeral head fractures
Rheumatoid arthritis (with intact rotator cuff)
Avascular necrosis of the humeral head
Revision of a hemi-arthroplasty with a total arthroplasty
Revision of a reverse prosthesis with an anatomic prosthesis
Revision to increase the size of the stem (length and/or diameter)
Revision of a glenoid prosthesis, a glenoid insert or a competitor's prosthesis
For reverse type:
Offset osteoarthritis of the shoulder
Massive and non-repairable rotator cuff tears
Rheumatoid arthritis (with degenerative rotator cuff)
Revision of an anatomic prosthesis with a reverse prosthesis
Revision to increase the size of the stem (length and/or diameter)
Revision of a glenoid prosthesis, a glenoid insert or a competitor's prosthesis
Exclusion
Exclusion Criteria:
Patient is unwilling or unable to give consent or to comply with the follow-upprogram
Patient is known to be pregnant or breastfeeding
Patient has any condition that would, in the judgment of the Investigator, place thepatient at undue risk or interfere with the study
Patient is a vulnerable subject (prisoner, mentally incompetent or unable tounderstand what participation to the study entails, a known alcohol or drug abuser,anticipated to be non-compliant)
Patient who displays any of the following contra-indications cannot be included inthis study:
Local or systemic infections
Severe muscular, neurological, or vascular deficiency of the affected joint
Poor bone quality likely to prevent osseointegration or to affect the long-termstability of the implant (Paget's disease, osteoporosis)
Any concomitant conditions likely to affect the function of the implant
Allergy to any of the implant components
Do not use the modular humeral version (screwed connection) in cases where thecorolla cannot be two-thirds covered with bone stock and including the screwedmodular stem/corolla junction
Study Design
Study Description
Connect with a study center
Lyon Ortho Clinic
Lyon,
FranceSite Not Available
Clinique Saint-Jean (Group ORTHOSUD)
Saint Jean de Védas,
FranceSite Not Available
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