Trial Outcomes & Findings for Multi Centre Study on TESS V2 Shoulder System (NCT NCT03431857)

NCT ID: NCT03431857

Last Updated: 2021-10-19

Results Overview

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.

• Recruitment status: COMPLETED
• Target enrollment: 106 participants
• Primary outcome timeframe: Pre-operative, 5 years follow-up
• Results posted on: 2021-10-19

Participant Flow

Participant milestones

Measure	TESS V2 Prosthesis Single study patient cohort, including 106 patients who meet the inclusion/exclusion criteria and who received the TESS V2 shoulder prosthesis.
Overall Study STARTED	106
Overall Study COMPLETED	52
Overall Study NOT COMPLETED	54

Reasons for withdrawal

Measure	TESS V2 Prosthesis Single study patient cohort, including 106 patients who meet the inclusion/exclusion criteria and who received the TESS V2 shoulder prosthesis.
Overall Study Death	6
Overall Study Lost to Follow-up	41
Overall Study Adverse Event	6
Overall Study Withdrawal by Subject	1

Baseline Characteristics

The gender of 2 patients (1.9% of participants) was unspecified in the CRF.

Baseline characteristics by cohort

Measure	TESS V2 Prosthesis n=106 Participants Single study patient cohort, including 106 patients who meet the inclusion/exclusion criteria and who received the TESS V2 shoulder prosthesis.
Age, Continuous	73.3 years STANDARD_DEVIATION 8 • n=106 Participants
Sex: Female, Male Female	74 Participants n=104 Participants • The gender of 2 patients (1.9% of participants) was unspecified in the CRF.
Sex: Female, Male Male	30 Participants n=104 Participants • The gender of 2 patients (1.9% of participants) was unspecified in the CRF.
Height cm	163.7 cm STANDARD_DEVIATION 7.6 • n=102 Participants • Height was not available for 4 of the patients.
Weight kg	75.9 Kg STANDARD_DEVIATION 17.1 • n=104 Participants • Weight was not available for 2 of the patients.

PRIMARY outcome

Timeframe: Pre-operative, 5 years follow-up

Population: Number of cases for each time point: 99 (pre-operative) and 50 (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.

Outcome measures

Measure	TESS V2 Prosthesis n=99 Participants Single study patient cohort, including 106 patients who meet the inclusion/exclusion criteria and who received the TESS V2 shoulder prosthesis.
Constant Shoulder Score Pre-operative	27.36 score on a scale Standard Deviation 13.95
Constant Shoulder Score 5 years follow-up	63.5 score on a scale Standard Deviation 9.86

SECONDARY outcome

Timeframe: Pre-operative, 5 years follow-up

Population: Number of cases for each time point: 92 (pre-operative) and 50 (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.

Outcome measures

Measure	TESS V2 Prosthesis n=92 Participants Single study patient cohort, including 106 patients who meet the inclusion/exclusion criteria and who received the TESS V2 shoulder prosthesis.
Active Anterior Elevation Pre-operative	89.02 degrees Standard Deviation 36.3
Active Anterior Elevation 5 years follow-up	131 degrees Standard Deviation 19.09

SECONDARY outcome

Timeframe: Pre-operative, 5 years follow-up

Population: Number of cases for each time point: 91 (pre-operative) and 50 (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.

Outcome measures

Measure	TESS V2 Prosthesis n=91 Participants Single study patient cohort, including 106 patients who meet the inclusion/exclusion criteria and who received the TESS V2 shoulder prosthesis.
Active Lateral Elevation Pre-operative	72.57 degrees Standard Deviation 40.17
Active Lateral Elevation 5 years follow-up	105.70 degrees Standard Deviation 17.67

SECONDARY outcome

Timeframe: Pre-operative, 5 years follow-up

Population: Number of cases for each time point: 96 (pre-operative) and 50 (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.

Outcome measures

Measure	TESS V2 Prosthesis n=96 Participants Single study patient cohort, including 106 patients who meet the inclusion/exclusion criteria and who received the TESS V2 shoulder prosthesis.
Active External Rotation RE1 Pre-operative	22.45 degrees Standard Deviation 18.58
Active External Rotation RE1 5 years follow-up	34.80 degrees Standard Deviation 18.54

SECONDARY outcome

Timeframe: Pre-operative, 5 years follow-up

Population: Number of cases for each time point: 76 (pre-operative) and 49 (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.

Outcome measures

Measure	TESS V2 Prosthesis n=76 Participants Single study patient cohort, including 106 patients who meet the inclusion/exclusion criteria and who received the TESS V2 shoulder prosthesis.
Active External Rotation RE2 Pre-operative	28.22 degrees Standard Deviation 26.1
Active External Rotation RE2 5 years follow-up	61.94 degrees Standard Deviation 17.22

SECONDARY outcome

Timeframe: Pre-operative, 5 years follow-up

Population: Number of cases for each time point: 95 (pre-operative) and 50 (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.

Outcome measures

Measure	TESS V2 Prosthesis n=95 Participants Single study patient cohort, including 106 patients who meet the inclusion/exclusion criteria and who received the TESS V2 shoulder prosthesis.
Passive Elevation Pre-operative	112.32 degrees Standard Deviation 27.40
Passive Elevation 5 years follow-up	140.90 degrees Standard Deviation 18.15

SECONDARY outcome

Timeframe: Pre-operative, 5 years follow-up

Population: Number of cases for each time point: 95 (pre-operative) and 49 (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.

Outcome measures

Measure	TESS V2 Prosthesis n=95 Participants Single study patient cohort, including 106 patients who meet the inclusion/exclusion criteria and who received the TESS V2 shoulder prosthesis.
Passive External Rotation Pre-operative	28.37 degrees Standard Deviation 18
Passive External Rotation 5 years follow-up	43.47 degrees Standard Deviation 19.13

SECONDARY outcome

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.

Population: Number of radiographies analysed: 90 immediately post-operative, 83 at 6 weeks follow-up, 85 at 6 months follow-up, 75 at 1 year follow-up, 59 at 2 years follow-up, 36 at 3 years follow-up, 22 at 4 years follow-up, 44 at 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.

Outcome measures

Measure	TESS V2 Prosthesis n=90 radiographies Single study patient cohort, including 106 patients who meet the inclusion/exclusion criteria and who received the TESS V2 shoulder prosthesis.
Radiographic Evaluation Immediate post-operative	2 changed radiographies compared to pre-op
Radiographic Evaluation 6 weeks follow-up	6 changed radiographies compared to pre-op
Radiographic Evaluation 6 months follow-up	7 changed radiographies compared to pre-op
Radiographic Evaluation 1 year follow-up	7 changed radiographies compared to pre-op
Radiographic Evaluation 2 years follow-up	11 changed radiographies compared to pre-op
Radiographic Evaluation 3 years follow-up	5 changed radiographies compared to pre-op
Radiographic Evaluation 4 years follow-up	1 changed radiographies compared to pre-op
Radiographic Evaluation 5 years follow-up	12 changed radiographies compared to pre-op

SECONDARY outcome

Timeframe: 5 years follow-up

Population: Number of cases analyzed for each time point: 102 implanted devices (immediate post-operative) and 43 implanted devices (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.

Outcome measures

Measure	TESS V2 Prosthesis n=43 implanted devices Single study patient cohort, including 106 patients who meet the inclusion/exclusion criteria and who received the TESS V2 shoulder prosthesis.
Survivorship	94.4 Percentage of implanted devices Interval 89.7 to 99.4

Adverse Events

TESS V2 Prosthesis

Serious events: 44 serious events

Other events: 16 other events

Deaths: 5 deaths

Serious adverse events

Measure	TESS V2 Prosthesis n=106 participants at risk Single study patient cohort, including 106 patients who meet the inclusion/exclusion criteria and who received the TESS V2 shoulder prosthesis.
Surgical and medical procedures Revision	5.7% 6/106 • Number of events 6 • Reported Adverse Events (AEs) include events from the date each subject was implanted up to 5 years after surgery, when the last follow-up was performed and patients completed the study. Adverse events were collected in an Adverse Event Form, which gathers information on the date of occurrence, the nature of the adverse event, whether the device was involved, which treatment was used and the treatment outcome.
Surgical and medical procedures Knee arthroplasty	3.8% 4/106 • Number of events 5 • Reported Adverse Events (AEs) include events from the date each subject was implanted up to 5 years after surgery, when the last follow-up was performed and patients completed the study. Adverse events were collected in an Adverse Event Form, which gathers information on the date of occurrence, the nature of the adverse event, whether the device was involved, which treatment was used and the treatment outcome.
Surgical and medical procedures Lumbar surgery	0.94% 1/106 • Number of events 1 • Reported Adverse Events (AEs) include events from the date each subject was implanted up to 5 years after surgery, when the last follow-up was performed and patients completed the study. Adverse events were collected in an Adverse Event Form, which gathers information on the date of occurrence, the nature of the adverse event, whether the device was involved, which treatment was used and the treatment outcome.
Surgical and medical procedures Shoulder surgery	5.7% 6/106 • Number of events 6 • Reported Adverse Events (AEs) include events from the date each subject was implanted up to 5 years after surgery, when the last follow-up was performed and patients completed the study. Adverse events were collected in an Adverse Event Form, which gathers information on the date of occurrence, the nature of the adverse event, whether the device was involved, which treatment was used and the treatment outcome.
Surgical and medical procedures Hip arthroplasty	2.8% 3/106 • Number of events 3 • Reported Adverse Events (AEs) include events from the date each subject was implanted up to 5 years after surgery, when the last follow-up was performed and patients completed the study. Adverse events were collected in an Adverse Event Form, which gathers information on the date of occurrence, the nature of the adverse event, whether the device was involved, which treatment was used and the treatment outcome.
Surgical and medical procedures Hand surgery	0.94% 1/106 • Number of events 1 • Reported Adverse Events (AEs) include events from the date each subject was implanted up to 5 years after surgery, when the last follow-up was performed and patients completed the study. Adverse events were collected in an Adverse Event Form, which gathers information on the date of occurrence, the nature of the adverse event, whether the device was involved, which treatment was used and the treatment outcome.
Surgical and medical procedures Elbow arthroplasty	0.94% 1/106 • Number of events 1 • Reported Adverse Events (AEs) include events from the date each subject was implanted up to 5 years after surgery, when the last follow-up was performed and patients completed the study. Adverse events were collected in an Adverse Event Form, which gathers information on the date of occurrence, the nature of the adverse event, whether the device was involved, which treatment was used and the treatment outcome.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cancer	4.7% 5/106 • Number of events 6 • Reported Adverse Events (AEs) include events from the date each subject was implanted up to 5 years after surgery, when the last follow-up was performed and patients completed the study. Adverse events were collected in an Adverse Event Form, which gathers information on the date of occurrence, the nature of the adverse event, whether the device was involved, which treatment was used and the treatment outcome.
Infections and infestations Respiratory infection	3.8% 4/106 • Number of events 5 • Reported Adverse Events (AEs) include events from the date each subject was implanted up to 5 years after surgery, when the last follow-up was performed and patients completed the study. Adverse events were collected in an Adverse Event Form, which gathers information on the date of occurrence, the nature of the adverse event, whether the device was involved, which treatment was used and the treatment outcome.
Cardiac disorders Stroke	1.9% 2/106 • Number of events 3 • Reported Adverse Events (AEs) include events from the date each subject was implanted up to 5 years after surgery, when the last follow-up was performed and patients completed the study. Adverse events were collected in an Adverse Event Form, which gathers information on the date of occurrence, the nature of the adverse event, whether the device was involved, which treatment was used and the treatment outcome.
Cardiac disorders Cardiac arrest	1.9% 2/106 • Number of events 2 • Reported Adverse Events (AEs) include events from the date each subject was implanted up to 5 years after surgery, when the last follow-up was performed and patients completed the study. Adverse events were collected in an Adverse Event Form, which gathers information on the date of occurrence, the nature of the adverse event, whether the device was involved, which treatment was used and the treatment outcome.
Renal and urinary disorders Urinary disorder	1.9% 2/106 • Number of events 2 • Reported Adverse Events (AEs) include events from the date each subject was implanted up to 5 years after surgery, when the last follow-up was performed and patients completed the study. Adverse events were collected in an Adverse Event Form, which gathers information on the date of occurrence, the nature of the adverse event, whether the device was involved, which treatment was used and the treatment outcome.
Renal and urinary disorders Kidney disorder	0.94% 1/106 • Number of events 1 • Reported Adverse Events (AEs) include events from the date each subject was implanted up to 5 years after surgery, when the last follow-up was performed and patients completed the study. Adverse events were collected in an Adverse Event Form, which gathers information on the date of occurrence, the nature of the adverse event, whether the device was involved, which treatment was used and the treatment outcome.
Gastrointestinal disorders Gastrointestinal bleeding	0.94% 1/106 • Number of events 1 • Reported Adverse Events (AEs) include events from the date each subject was implanted up to 5 years after surgery, when the last follow-up was performed and patients completed the study. Adverse events were collected in an Adverse Event Form, which gathers information on the date of occurrence, the nature of the adverse event, whether the device was involved, which treatment was used and the treatment outcome.
Musculoskeletal and connective tissue disorders Fracture thoracical vertebrae	0.94% 1/106 • Number of events 1 • Reported Adverse Events (AEs) include events from the date each subject was implanted up to 5 years after surgery, when the last follow-up was performed and patients completed the study. Adverse events were collected in an Adverse Event Form, which gathers information on the date of occurrence, the nature of the adverse event, whether the device was involved, which treatment was used and the treatment outcome.
Respiratory, thoracic and mediastinal disorders Lung edema	0.94% 1/106 • Number of events 1 • Reported Adverse Events (AEs) include events from the date each subject was implanted up to 5 years after surgery, when the last follow-up was performed and patients completed the study. Adverse events were collected in an Adverse Event Form, which gathers information on the date of occurrence, the nature of the adverse event, whether the device was involved, which treatment was used and the treatment outcome.
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.94% 1/106 • Number of events 1 • Reported Adverse Events (AEs) include events from the date each subject was implanted up to 5 years after surgery, when the last follow-up was performed and patients completed the study. Adverse events were collected in an Adverse Event Form, which gathers information on the date of occurrence, the nature of the adverse event, whether the device was involved, which treatment was used and the treatment outcome.
Musculoskeletal and connective tissue disorders Knee wound	0.94% 1/106 • Number of events 1 • Reported Adverse Events (AEs) include events from the date each subject was implanted up to 5 years after surgery, when the last follow-up was performed and patients completed the study. Adverse events were collected in an Adverse Event Form, which gathers information on the date of occurrence, the nature of the adverse event, whether the device was involved, which treatment was used and the treatment outcome.
Musculoskeletal and connective tissue disorders Pubis bone fracture	0.94% 1/106 • Number of events 1 • Reported Adverse Events (AEs) include events from the date each subject was implanted up to 5 years after surgery, when the last follow-up was performed and patients completed the study. Adverse events were collected in an Adverse Event Form, which gathers information on the date of occurrence, the nature of the adverse event, whether the device was involved, which treatment was used and the treatment outcome.
Musculoskeletal and connective tissue disorders Stenosis	0.94% 1/106 • Number of events 1 • Reported Adverse Events (AEs) include events from the date each subject was implanted up to 5 years after surgery, when the last follow-up was performed and patients completed the study. Adverse events were collected in an Adverse Event Form, which gathers information on the date of occurrence, the nature of the adverse event, whether the device was involved, which treatment was used and the treatment outcome.
Musculoskeletal and connective tissue disorders Wrist fracture	0.94% 1/106 • Number of events 1 • Reported Adverse Events (AEs) include events from the date each subject was implanted up to 5 years after surgery, when the last follow-up was performed and patients completed the study. Adverse events were collected in an Adverse Event Form, which gathers information on the date of occurrence, the nature of the adverse event, whether the device was involved, which treatment was used and the treatment outcome.
Musculoskeletal and connective tissue disorders Humerus fracture	0.94% 1/106 • Number of events 1 • Reported Adverse Events (AEs) include events from the date each subject was implanted up to 5 years after surgery, when the last follow-up was performed and patients completed the study. Adverse events were collected in an Adverse Event Form, which gathers information on the date of occurrence, the nature of the adverse event, whether the device was involved, which treatment was used and the treatment outcome.
Musculoskeletal and connective tissue disorders Shoulder fracture	0.94% 1/106 • Number of events 1 • Reported Adverse Events (AEs) include events from the date each subject was implanted up to 5 years after surgery, when the last follow-up was performed and patients completed the study. Adverse events were collected in an Adverse Event Form, which gathers information on the date of occurrence, the nature of the adverse event, whether the device was involved, which treatment was used and the treatment outcome.
Musculoskeletal and connective tissue disorders Pseudoarthritis rhizomelic	0.94% 1/106 • Number of events 1 • Reported Adverse Events (AEs) include events from the date each subject was implanted up to 5 years after surgery, when the last follow-up was performed and patients completed the study. Adverse events were collected in an Adverse Event Form, which gathers information on the date of occurrence, the nature of the adverse event, whether the device was involved, which treatment was used and the treatment outcome.
Musculoskeletal and connective tissue disorders Neuropathy and athrosis of inferior limbs	0.94% 1/106 • Number of events 1 • Reported Adverse Events (AEs) include events from the date each subject was implanted up to 5 years after surgery, when the last follow-up was performed and patients completed the study. Adverse events were collected in an Adverse Event Form, which gathers information on the date of occurrence, the nature of the adverse event, whether the device was involved, which treatment was used and the treatment outcome.
Musculoskeletal and connective tissue disorders Radius fracture	0.94% 1/106 • Number of events 1 • Reported Adverse Events (AEs) include events from the date each subject was implanted up to 5 years after surgery, when the last follow-up was performed and patients completed the study. Adverse events were collected in an Adverse Event Form, which gathers information on the date of occurrence, the nature of the adverse event, whether the device was involved, which treatment was used and the treatment outcome.
Musculoskeletal and connective tissue disorders Osteoporosis, fractures	0.94% 1/106 • Number of events 1 • Reported Adverse Events (AEs) include events from the date each subject was implanted up to 5 years after surgery, when the last follow-up was performed and patients completed the study. Adverse events were collected in an Adverse Event Form, which gathers information on the date of occurrence, the nature of the adverse event, whether the device was involved, which treatment was used and the treatment outcome.
Musculoskeletal and connective tissue disorders Acromio-clavicular arthrosis	0.94% 1/106 • Number of events 1 • Reported Adverse Events (AEs) include events from the date each subject was implanted up to 5 years after surgery, when the last follow-up was performed and patients completed the study. Adverse events were collected in an Adverse Event Form, which gathers information on the date of occurrence, the nature of the adverse event, whether the device was involved, which treatment was used and the treatment outcome.
Musculoskeletal and connective tissue disorders Rachialgia and scapulalgia	0.94% 1/106 • Number of events 1 • Reported Adverse Events (AEs) include events from the date each subject was implanted up to 5 years after surgery, when the last follow-up was performed and patients completed the study. Adverse events were collected in an Adverse Event Form, which gathers information on the date of occurrence, the nature of the adverse event, whether the device was involved, which treatment was used and the treatment outcome.
Musculoskeletal and connective tissue disorders Cubital and Carpal Tunnel Syndrome	0.94% 1/106 • Number of events 1 • Reported Adverse Events (AEs) include events from the date each subject was implanted up to 5 years after surgery, when the last follow-up was performed and patients completed the study. Adverse events were collected in an Adverse Event Form, which gathers information on the date of occurrence, the nature of the adverse event, whether the device was involved, which treatment was used and the treatment outcome.
Musculoskeletal and connective tissue disorders Humerocubital ostephytes	0.94% 1/106 • Number of events 1 • Reported Adverse Events (AEs) include events from the date each subject was implanted up to 5 years after surgery, when the last follow-up was performed and patients completed the study. Adverse events were collected in an Adverse Event Form, which gathers information on the date of occurrence, the nature of the adverse event, whether the device was involved, which treatment was used and the treatment outcome.
General disorders Dementia + respiratory infection	0.94% 1/106 • Number of events 1 • Reported Adverse Events (AEs) include events from the date each subject was implanted up to 5 years after surgery, when the last follow-up was performed and patients completed the study. Adverse events were collected in an Adverse Event Form, which gathers information on the date of occurrence, the nature of the adverse event, whether the device was involved, which treatment was used and the treatment outcome.
General disorders Weakness	0.94% 1/106 • Number of events 1 • Reported Adverse Events (AEs) include events from the date each subject was implanted up to 5 years after surgery, when the last follow-up was performed and patients completed the study. Adverse events were collected in an Adverse Event Form, which gathers information on the date of occurrence, the nature of the adverse event, whether the device was involved, which treatment was used and the treatment outcome.
General disorders Stress incontinence	0.94% 1/106 • Number of events 1 • Reported Adverse Events (AEs) include events from the date each subject was implanted up to 5 years after surgery, when the last follow-up was performed and patients completed the study. Adverse events were collected in an Adverse Event Form, which gathers information on the date of occurrence, the nature of the adverse event, whether the device was involved, which treatment was used and the treatment outcome.
Blood and lymphatic system disorders Anemia	0.94% 1/106 • Number of events 1 • Reported Adverse Events (AEs) include events from the date each subject was implanted up to 5 years after surgery, when the last follow-up was performed and patients completed the study. Adverse events were collected in an Adverse Event Form, which gathers information on the date of occurrence, the nature of the adverse event, whether the device was involved, which treatment was used and the treatment outcome.
Eye disorders Vitrectomy	1.9% 2/106 • Number of events 2 • Reported Adverse Events (AEs) include events from the date each subject was implanted up to 5 years after surgery, when the last follow-up was performed and patients completed the study. Adverse events were collected in an Adverse Event Form, which gathers information on the date of occurrence, the nature of the adverse event, whether the device was involved, which treatment was used and the treatment outcome.
Skin and subcutaneous tissue disorders Head wound	0.94% 1/106 • Number of events 1 • Reported Adverse Events (AEs) include events from the date each subject was implanted up to 5 years after surgery, when the last follow-up was performed and patients completed the study. Adverse events were collected in an Adverse Event Form, which gathers information on the date of occurrence, the nature of the adverse event, whether the device was involved, which treatment was used and the treatment outcome.
Surgical and medical procedures Cement effraction	0.94% 1/106 • Number of events 1 • Reported Adverse Events (AEs) include events from the date each subject was implanted up to 5 years after surgery, when the last follow-up was performed and patients completed the study. Adverse events were collected in an Adverse Event Form, which gathers information on the date of occurrence, the nature of the adverse event, whether the device was involved, which treatment was used and the treatment outcome.
Nervous system disorders Parkinson	0.94% 1/106 • Number of events 1 • Reported Adverse Events (AEs) include events from the date each subject was implanted up to 5 years after surgery, when the last follow-up was performed and patients completed the study. Adverse events were collected in an Adverse Event Form, which gathers information on the date of occurrence, the nature of the adverse event, whether the device was involved, which treatment was used and the treatment outcome.
Nervous system disorders Hyperalgic lumbosciatic	0.94% 1/106 • Number of events 1 • Reported Adverse Events (AEs) include events from the date each subject was implanted up to 5 years after surgery, when the last follow-up was performed and patients completed the study. Adverse events were collected in an Adverse Event Form, which gathers information on the date of occurrence, the nature of the adverse event, whether the device was involved, which treatment was used and the treatment outcome.

Other adverse events

Measure	TESS V2 Prosthesis n=106 participants at risk Single study patient cohort, including 106 patients who meet the inclusion/exclusion criteria and who received the TESS V2 shoulder prosthesis.
Musculoskeletal and connective tissue disorders Dislocation	1.9% 2/106 • Number of events 2 • Reported Adverse Events (AEs) include events from the date each subject was implanted up to 5 years after surgery, when the last follow-up was performed and patients completed the study. Adverse events were collected in an Adverse Event Form, which gathers information on the date of occurrence, the nature of the adverse event, whether the device was involved, which treatment was used and the treatment outcome.
Musculoskeletal and connective tissue disorders Shoulder pain	2.8% 3/106 • Number of events 3 • Reported Adverse Events (AEs) include events from the date each subject was implanted up to 5 years after surgery, when the last follow-up was performed and patients completed the study. Adverse events were collected in an Adverse Event Form, which gathers information on the date of occurrence, the nature of the adverse event, whether the device was involved, which treatment was used and the treatment outcome.
Renal and urinary disorders Urinary retention	0.94% 1/106 • Number of events 1 • Reported Adverse Events (AEs) include events from the date each subject was implanted up to 5 years after surgery, when the last follow-up was performed and patients completed the study. Adverse events were collected in an Adverse Event Form, which gathers information on the date of occurrence, the nature of the adverse event, whether the device was involved, which treatment was used and the treatment outcome.
Musculoskeletal and connective tissue disorders Heterotopic ossification	0.94% 1/106 • Number of events 1 • Reported Adverse Events (AEs) include events from the date each subject was implanted up to 5 years after surgery, when the last follow-up was performed and patients completed the study. Adverse events were collected in an Adverse Event Form, which gathers information on the date of occurrence, the nature of the adverse event, whether the device was involved, which treatment was used and the treatment outcome.
Nervous system disorders Nerve injury	0.94% 1/106 • Number of events 1 • Reported Adverse Events (AEs) include events from the date each subject was implanted up to 5 years after surgery, when the last follow-up was performed and patients completed the study. Adverse events were collected in an Adverse Event Form, which gathers information on the date of occurrence, the nature of the adverse event, whether the device was involved, which treatment was used and the treatment outcome.
Gastrointestinal disorders Ileus	0.94% 1/106 • Number of events 1 • Reported Adverse Events (AEs) include events from the date each subject was implanted up to 5 years after surgery, when the last follow-up was performed and patients completed the study. Adverse events were collected in an Adverse Event Form, which gathers information on the date of occurrence, the nature of the adverse event, whether the device was involved, which treatment was used and the treatment outcome.
Musculoskeletal and connective tissue disorders Neck pain, paresthesia	0.94% 1/106 • Number of events 1 • Reported Adverse Events (AEs) include events from the date each subject was implanted up to 5 years after surgery, when the last follow-up was performed and patients completed the study. Adverse events were collected in an Adverse Event Form, which gathers information on the date of occurrence, the nature of the adverse event, whether the device was involved, which treatment was used and the treatment outcome.
Musculoskeletal and connective tissue disorders Shoulder injury	0.94% 1/106 • Number of events 1 • Reported Adverse Events (AEs) include events from the date each subject was implanted up to 5 years after surgery, when the last follow-up was performed and patients completed the study. Adverse events were collected in an Adverse Event Form, which gathers information on the date of occurrence, the nature of the adverse event, whether the device was involved, which treatment was used and the treatment outcome.
Infections and infestations Respiratory infection	0.94% 1/106 • Number of events 1 • Reported Adverse Events (AEs) include events from the date each subject was implanted up to 5 years after surgery, when the last follow-up was performed and patients completed the study. Adverse events were collected in an Adverse Event Form, which gathers information on the date of occurrence, the nature of the adverse event, whether the device was involved, which treatment was used and the treatment outcome.
Musculoskeletal and connective tissue disorders Biceps rupture	0.94% 1/106 • Number of events 1 • Reported Adverse Events (AEs) include events from the date each subject was implanted up to 5 years after surgery, when the last follow-up was performed and patients completed the study. Adverse events were collected in an Adverse Event Form, which gathers information on the date of occurrence, the nature of the adverse event, whether the device was involved, which treatment was used and the treatment outcome.
Nervous system disorders Reflex sympathetic syndrom	0.94% 1/106 • Number of events 1 • Reported Adverse Events (AEs) include events from the date each subject was implanted up to 5 years after surgery, when the last follow-up was performed and patients completed the study. Adverse events were collected in an Adverse Event Form, which gathers information on the date of occurrence, the nature of the adverse event, whether the device was involved, which treatment was used and the treatment outcome.
Infections and infestations Postoperative inflammation suspected	0.94% 1/106 • Number of events 1 • Reported Adverse Events (AEs) include events from the date each subject was implanted up to 5 years after surgery, when the last follow-up was performed and patients completed the study. Adverse events were collected in an Adverse Event Form, which gathers information on the date of occurrence, the nature of the adverse event, whether the device was involved, which treatment was used and the treatment outcome.
Musculoskeletal and connective tissue disorders Acromion inflammation	0.94% 1/106 • Number of events 1 • Reported Adverse Events (AEs) include events from the date each subject was implanted up to 5 years after surgery, when the last follow-up was performed and patients completed the study. Adverse events were collected in an Adverse Event Form, which gathers information on the date of occurrence, the nature of the adverse event, whether the device was involved, which treatment was used and the treatment outcome.
Musculoskeletal and connective tissue disorders Acromial fracture	0.94% 1/106 • Number of events 1 • Reported Adverse Events (AEs) include events from the date each subject was implanted up to 5 years after surgery, when the last follow-up was performed and patients completed the study. Adverse events were collected in an Adverse Event Form, which gathers information on the date of occurrence, the nature of the adverse event, whether the device was involved, which treatment was used and the treatment outcome.
Surgical and medical procedures Screw breakage	0.94% 1/106 • Number of events 1 • Reported Adverse Events (AEs) include events from the date each subject was implanted up to 5 years after surgery, when the last follow-up was performed and patients completed the study. Adverse events were collected in an Adverse Event Form, which gathers information on the date of occurrence, the nature of the adverse event, whether the device was involved, which treatment was used and the treatment outcome.

Additional Information

Emilie Rohmer, Clinical Ops manager

Zimmer Biomet

Phone: +41588548210

Email: emilie.rohmer@zimmerbiomet.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place