N/A
Completed N=106
Multi Centre Study on TESS V2 Shoulder System
Source: ClinicalTrials.gov NCT03431857 ↗Enrolled (actual)
106
Serious AEs
41.5%
Results posted
Oct 2021
Primary outcomePrimary: Constant Shoulder Score — 27.36; 63.5 score on a scale
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Constant Shoulder Score |
27.36; 63.5 | — |
| SECONDARY Active Anterior Elevation |
89.02; 131 | — |
| SECONDARY Active Lateral Elevation |
72.57; 105.70 | — |
| SECONDARY Active External Rotation RE1 |
22.45; 34.80 | — |
| SECONDARY Active External Rotation RE2 |
28.22; 61.94 | — |
| SECONDARY Passive Elevation |
112.32; 140.90 | — |
| SECONDARY Passive External Rotation |
28.37; 43.47 | — |
| SECONDARY Radiographic Evaluation |
2; 6; 7; 7; 11; 5 | — |
| SECONDARY Survivorship |
94.4 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT03431857). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.