Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
67 participants
OBSERVATIONAL
2022-02-01
2026-12-31
Brief Summary
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Detailed Description
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A maximum of 5 study centers will be involved in Europe. A total number of 146 implants, 73 T.E.S.S.® anatomic and 73 T.E.S.S.® reverse, will be included into the study. Each clinical site will be allowed to enroll a maximum 88 patients (60% of the total study cohort). Ethics Committee (EC) approval has to be obtained prior to conducting this study. All potential subjects will be required to participate in an informed consent process and sign the EC approved written informed consent prior to study enrollment.
Conditions
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Study Design
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COHORT
OTHER
Study Groups
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TESS Anatomic
Subjects who received the Anatomic T.E.S.S.® V3 Modular Total Shoulder System to relieve pain and restore the joint function and who met the inclusion/exclusion criteria.
Anatomic TESS V3
Implantation of the T.E.S.S.® V3 Modular Total Shoulder System, Anatomic configuration.
TESS Reverse
Subjects who received the Reverse T.E.S.S.® V3 Modular Total Shoulder System to relieve pain and restore the joint function and who met the inclusion/exclusion criteria.
Reverse TESS V3
Implantation of the T.E.S.S.® V3 Modular Total Shoulder System, Reverse configuration.
Interventions
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Anatomic TESS V3
Implantation of the T.E.S.S.® V3 Modular Total Shoulder System, Anatomic configuration.
Reverse TESS V3
Implantation of the T.E.S.S.® V3 Modular Total Shoulder System, Reverse configuration.
Eligibility Criteria
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Inclusion Criteria
* Patient is capable of understanding the surgeon's explanations and following his instructions, 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.® V3 Modular 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 Criteria
* Patient is known to be pregnant or breastfeeding
* Patient has any condition that would, in the judgment of the Investigator, place the patient at undue risk or interfere with the study
* Patient is a vulnerable subject (prisoner, mentally incompetent or unable to understand 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 in this 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-term stability 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 the corolla cannot be two-thirds covered with bone stock and including the screwed modular stem/corolla junction
18 Years
ALL
No
Sponsors
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Zimmer Biomet
INDUSTRY
Responsible Party
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Principal Investigators
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Emilie Rohmer
Role: STUDY_DIRECTOR
Zimmer Biomet
Locations
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Lyon Ortho Clinic
Lyon, , France
Clinique Saint-Jean (Group ORTHOSUD)
Saint-Jean-de-Védas, , France
Countries
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Other Identifiers
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CME2019-44E
Identifier Type: -
Identifier Source: org_study_id
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