N/A
N=106
Multi Centre Study on TESS V2 Shoulder System
Osteoarthritis Shoulder · Fracture · Rheumatoid Arthritis · Avascular Necrosis · Rotator Cuff Tear
Bottom Line
View on ClinicalTrials.gov: NCT03431857 ↗Enrolled (actual)
106
Serious AEs
41.5%
Results posted
Oct 2021
Primary outcome: Primary: Constant Shoulder Score — 27.36; 63.5 score on a scale
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- TESS V2 (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Zimmer Biomet
- Primary completion
- Dec 2015
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 | — |
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.
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.