Clinical trial NCT03431857: Multi Centre Study on TESS V2 Shoulder System
Official title: Retrospective and Prospective, Multi Centre Study on T.E.S.S® V2 Shoulder System
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Osteoarthritis Shoulder
Fracture
Rheumatoid Arthritis
Avascular Necrosis
Rotator Cuff Tear
Revision
Keywords: Shoulder arthroplasty
Medical device
Shoulder prosthesis
Performance
Lead sponsor: Zimmer Biomet
Sponsor class: INDUSTRY
First posted: 2018-02-13
Enrollment: 106
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: Patients in need of Total Shoulder Arthroplasty (primary or revision) who receive the TESS V2 and who meet all of the inclusion and none of the exclusion criteria.

Brief 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.

Detailed description: The objective of this retrospective and prospective, multicenter, non-controlled Post Market Clinical Follow-up study is to evaluate the mid-term (5-year) clinical performance of the TESS Version 2 Anatomic and Reverse prostheses in shoulder arthroplasty. The primary outcome is defined as the clinical performance determined using Constant Score. The secondary outcomes are the passive and active mobility, the radiographic evaluation, the complications (including dislocation and revisions/removals) and survivorship.

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

Primary outcomes:
measure: Constant Shoulder Score
timeFrame: Pre-operative, 5 years follow-up
Secondary outcomes:
measure: Active Anterior Elevation
timeFrame: Pre-operative, 5 years follow-up
measure: Active Lateral Elevation
timeFrame: Pre-operative, 5 years follow-up
measure: Active External Rotation RE1
timeFrame: Pre-operative, 5 years follow-up
measure: Active External Rotation RE2
timeFrame: Pre-operative, 5 years follow-up
measure: Passive Elevation
timeFrame: Pre-operative, 5 years follow-up
measure: Passive External Rotation
timeFrame: Pre-operative, 5 years follow-up
measure: Radiographic Evaluation
timeFrame: Immediate post-operative, 6 weeks follow-up, 6 months follow-up, 1 year follow-up, 2 years follow-up, 3 years follow-up, 4 years follow-up, 5 years follow-up.
measure: Survivorship
timeFrame: 5 years follow-up
Other outcomes:
Locations:
city: Sint-Niklaas
country: Belgium
facility: Orthokliniek Waasland
city: Berck
country: France
facility: Institut Calot
Study officials:
affiliation: Zimmer Biomet
name: Paola Vivoda
role: STUDY_DIRECTOR
References: