Multi Centre Study on TESS V2 Shoulder System

Retrospective and Prospective, Multi Centre Study on T.E.S.S® V2 Shoulder System

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03431857

Enrollment

106

Registered

2018-02-13

Start date

2010-10-20

Completion date

2019-12-31

Last updated

2021-10-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Avascular Necrosis, Fracture, Osteoarthritis Shoulder, Revision, Rheumatoid Arthritis, Rotator Cuff Tear

Keywords

Shoulder arthroplasty, Medical device, Shoulder prosthesis, Performance

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.

Interventions

DEVICETESS V2

Patients requiring the TESS V2 prosthesis.

Study design

Observational model

COHORT

Time perspective

OTHER

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Constant Shoulder Score	Pre-operative, 5 years follow-up	The Constant Murley score is a multi-item scale assessing the level of pain and the ability to carry out the normal daily activities of the patient. The test is divided into four subscales: pain (0-15 points), activities of daily living (0-20 points), strength (0-25 points) and range of motion: forward elevation, external rotation, abduction and internal rotation of the shoulder (0-40 points). The results are here reported as final score, which ranges from 0 to 100, with 0 representing the worst and 100 the best shoulder function.

Secondary

Measure	Time frame	Description
Active Lateral Elevation	Pre-operative, 5 years follow-up	The active mobility is measured with 4 movements: active anterior elevation, active lateral elevation, external rotation elbow to body (RE 1) and external shoulder rotation in abduction at 90° (RE 2). Active lateral elevation measures the extent to which a patient can elevate the arm laterally and is here reported in degrees.
Active External Rotation RE1	Pre-operative, 5 years follow-up	The active mobility is measured with 4 movements: active anterior elevation, active lateral elevation, external rotation elbow to body (RE 1) and external shoulder rotation in abduction at 90° (RE 2). Active external rotation RE1 measures the extent to which a patient can rotate the bent arm externally and is here reported in degrees.
Active External Rotation RE2	Pre-operative, 5 years follow-up	The active mobility is measured with 4 movements: active anterior elevation, active lateral elevation, external rotation elbow to body (RE 1) and external shoulder rotation in abduction at 90° (RE 2). Active external rotation RE2 measures the extent to which a patient can rotate the arm externally from a position of 90° of abduction and is here reported in degrees.
Active Anterior Elevation	Pre-operative, 5 years follow-up	The active mobility is measured with 4 movements: active anterior elevation, active lateral elevation, external rotation elbow to body (RE 1) and external shoulder rotation in abduction at 90° (RE 2). Active anterior elevation measures the extent to which a patient can elevate the arm anteriorly and is here reported in degrees.
Passive External Rotation	Pre-operative, 5 years follow-up	The passive mobility is measured with 2 movements: elevation and external rotation elbow to body (RE 1). Passive external rotation elbow to body (RE 1) measures the extent to which the bent arm of the patient can be passively rotated externally and is here reported in degrees.
Radiographic Evaluation	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.	A complete radiographic evaluation (front view 3 rotations, lateral view) is completed pre-operatively. For the post-operative radiographic evaluations, the form is simplified and contains two options: unchanged or changed when compared to the preoperative x-ray, with presence of radiolucencies and/or notching. The number of changed radiographic evaluations per time point are here reported.
Survivorship	5 years follow-up	The Kaplan-Meier method is used to report implant survivorship. This outcome measures survivorship of the implanted devices from the date of implantation to the date of revision or intended revision up to 5 years post-operatively.
Passive Elevation	Pre-operative, 5 years follow-up	The passive mobility is measured with 2 movements: elevation and external rotation elbow to body (RE 1). Passive elevation measures the extent to which the arm of the patient can be passively elevated in the plane of the scapula and is here reported in degrees.

Countries

Belgium, France

Participant flow

Participants by arm

Arm	Count
TESS V2 Prosthesis Single study patient cohort, including 106 patients who meet the inclusion/exclusion criteria and who received the TESS V2 shoulder prosthesis.	106
Total	106

Withdrawals & dropouts

Period	Reason	FG000
Overall Study	Adverse Event	6
Overall Study	Death	6
Overall Study	Lost to Follow-up	41
Overall Study	Withdrawal by Subject	1

Baseline characteristics

Characteristic	TESS V2 Prosthesis	—
Age, Continuous	73.3 years STANDARD_DEVIATION 8	—
Height cm	163.7 cm STANDARD_DEVIATION 7.6	—
Race and Ethnicity Not Collected	—	— Participants
Sex: Female, Male Female	74 Participants	—
Sex: Female, Male Male	30 Participants	—
Weight kg	75.9 Kg STANDARD_DEVIATION 17.1	—

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	5 / 106
other Total, other adverse events	16 / 106
serious Total, serious adverse events	44 / 106

Outcome results

Primary

Constant Shoulder Score

The Constant Murley score is a multi-item scale assessing the level of pain and the ability to carry out the normal daily activities of the patient. The test is divided into four subscales: pain (0-15 points), activities of daily living (0-20 points), strength (0-25 points) and range of motion: forward elevation, external rotation, abduction and internal rotation of the shoulder (0-40 points). The results are here reported as final score, which ranges from 0 to 100, with 0 representing the worst and 100 the best shoulder function.