Trial Outcomes & Findings for Comparison of ARPE Prosthesis With the Literature (NCT NCT01904019)

NCT ID: NCT01904019

Last Updated: 2021-10-18

Results Overview

Grip strength is an indicator of muscle health in the hands and forearms and is measured with a hand-held dynamometer. The patients squeeze the dynamometer with all of their strength and the force applied is measured.

• Recruitment status: COMPLETED
• Target enrollment: 100 participants
• Primary outcome timeframe: Pre-operative, 1, 3 and 5 years follow-up
• Results posted on: 2021-10-18

Participant Flow

According to the protocol, 100 subjects were to be enrolled. Due to the inclusion of 5 bilateral patients the actual number of participants is 95, but 100 implants were included in the study.

Unit of analysis: implants

Participant milestones

Measure	ARPE Prosthesis Single study patient cohort, including 95 patients (100 implants) receiving the cementless ARPE trapeziometacarpal prosthesis.
Pre-operative STARTED	95 100
Pre-operative COMPLETED	95 100
Pre-operative NOT COMPLETED	0 0
1 Year Follow-up STARTED	95 100
1 Year Follow-up COMPLETED	86 91
1 Year Follow-up NOT COMPLETED	9 9
3 Year Follow-up STARTED	86 91
3 Year Follow-up COMPLETED	71 76
3 Year Follow-up NOT COMPLETED	15 15
5 Year Follow-up STARTED	71 76
5 Year Follow-up COMPLETED	65 69
5 Year Follow-up NOT COMPLETED	6 7

Reasons for withdrawal

Measure	ARPE Prosthesis Single study patient cohort, including 95 patients (100 implants) receiving the cementless ARPE trapeziometacarpal prosthesis.
1 Year Follow-up Withdrawal by Subject	4
1 Year Follow-up Impossibility to contact patient	5
3 Year Follow-up Withdrawal by Subject	1
3 Year Follow-up Impossibility to contact patient	14
5 Year Follow-up Withdrawal by Subject	2
5 Year Follow-up Impossibility to contact patient	4

Baseline Characteristics

Comparison of ARPE Prosthesis With the Literature

Baseline characteristics by cohort

Measure	ARPE Prosthesis n=100 implants Single study patient cohort, including 95 patients (100 implants) receiving the cementless ARPE trapeziometacarpal prosthesis.
Age, Continuous	62.3 years STANDARD_DEVIATION 7.2 • n=100 implants
Sex: Female, Male Female	87 implants n=100 implants
Sex: Female, Male Male	13 implants n=100 implants
Surgery Side Distribution Left	59 implants n=100 implants
Surgery Side Distribution Right	41 implants n=100 implants
Weight Distribution	70.4 kg STANDARD_DEVIATION 14.5 • n=100 implants
Height Distribution	165.3 cm STANDARD_DEVIATION 7.4 • n=100 implants
Other Joint Involvement of the Hand No	31 implants n=100 implants
Other Joint Involvement of the Hand Yes	69 implants n=100 implants
Previous Hand Surgeries/Treatments on Affected Hand No	77 implants n=100 implants
Previous Hand Surgeries/Treatments on Affected Hand Yes	23 implants n=100 implants
Trapezio Metacarpal Arthritis Disease Stage Stage II	26 implants n=100 implants
Trapezio Metacarpal Arthritis Disease Stage Stage III	68 implants n=100 implants
Trapezio Metacarpal Arthritis Disease Stage Stage IV	6 implants n=100 implants

PRIMARY outcome

Timeframe: Pre-operative, 1, 3 and 5 years follow-up

Population: Due to the inclusion of 5 bilateral patients the actual number of participants is 95, but 100 implants were included in the study. The results are indicated per implant number.

Grip strength is an indicator of muscle health in the hands and forearms and is measured with a hand-held dynamometer. The patients squeeze the dynamometer with all of their strength and the force applied is measured.

Outcome measures

Measure	ARPE Prosthesis n=100 implants Single study patient cohort, including 95 patients (100 implants) receiving the cementless ARPE trapeziometacarpal prosthesis.
Grip Strength Pre-operative	17.8 kg Standard Deviation 8.7
Grip Strength 1 year follow-up	23.4 kg Standard Deviation 9.2
Grip Strength 3 years follow-up	24.7 kg Standard Deviation 10.3
Grip Strength 5 years follow-up	25 kg Standard Deviation 8.9

PRIMARY outcome

Timeframe: Pre-operative, 1, 3 and 5 years follow-up

Population: Due to the inclusion of 5 bilateral patients the actual number of participants is 95, but 100 implants were included in the study. The results are indicated per implant number.

Key pinch strength is an indicator of muscle health and measures the precision grip by using a pinch dynamometer. The device is placed between the radial side of the index finger and thumb and the force applied while the patients pinch as hard as possible is measured.

Outcome measures

Measure	ARPE Prosthesis n=100 implants Single study patient cohort, including 95 patients (100 implants) receiving the cementless ARPE trapeziometacarpal prosthesis.
Key Pinch Strength Pre-operative	3.6 kg Standard Deviation 2.1
Key Pinch Strength 1 year follow-up	5.8 kg Standard Deviation 2.3
Key Pinch Strength 3 years follow-up	5.5 kg Standard Deviation 2.1
Key Pinch Strength 5 years follow-up	5.9 kg Standard Deviation 2.0

PRIMARY outcome

Timeframe: Pre-operative, 1, 3 and 5 years follow-up

Population: Due to the inclusion of 5 bilateral patients the actual number of participants is 95, but 100 implants were included in the study. The results are indicated per implant number.

Tip pinch strength is an indicator of muscle health and measures the precision grip by using a pinch dynamometer. The device is placed between the tip of the index finger and thumb and the force applied while the patients pinch as hard as possible is measured.

Outcome measures

Measure	ARPE Prosthesis n=100 implants Single study patient cohort, including 95 patients (100 implants) receiving the cementless ARPE trapeziometacarpal prosthesis.
Tip Pinch Strength Pre-operative	2.7 kg Standard Deviation 1.6
Tip Pinch Strength 1 year follow-up	4.5 kg Standard Deviation 1.8
Tip Pinch Strength 3 years follow-up	4.6 kg Standard Deviation 2
Tip Pinch Strength 5 years follow-up	4.5 kg Standard Deviation 1.5

PRIMARY outcome

Timeframe: Pre-operative, 1, 3 and 5 years follow-up

Population: Due to the inclusion of 5 bilateral patients the actual number of participants is 95, but 100 implants were included in the study. The results are indicated per implant number.

Pain level is collected with VAS (Visual Analog Scale): the patients are asked to mark their current pain level on a horizontal line containing values ranging from 0 (no pain) to 100 (very severe pain).

Outcome measures

Measure	ARPE Prosthesis n=100 implants Single study patient cohort, including 95 patients (100 implants) receiving the cementless ARPE trapeziometacarpal prosthesis.
VAS Pain Pre-operative	59.3 score on a scale Standard Deviation 19.5
VAS Pain 1 year follow-up	11.1 score on a scale Standard Deviation 14.8
VAS Pain 3 years follow-up	10.3 score on a scale Standard Deviation 19.6
VAS Pain 5 years follow-up	7.1 score on a scale Standard Deviation 15.1

SECONDARY outcome

Timeframe: Pre-operative, 1, 3 and 5 years follow-up

Population: Due to the inclusion of 5 bilateral patients the actual number of participants is 95, but 100 implants were included in the study. The results are indicated per implant number.

The range of motion (ROM) is the extent of movement of a joint and indicates the range through which the joint can be moved. ROM in radial abduction is measured while the patients move the thumb in parallel to the palm.

Outcome measures

Measure	ARPE Prosthesis n=100 implants Single study patient cohort, including 95 patients (100 implants) receiving the cementless ARPE trapeziometacarpal prosthesis.
Motion - ROM Measurement - Radial Abduction Pre-operative	41.5 degrees Standard Deviation 7.1
Motion - ROM Measurement - Radial Abduction 1 year follow-up	53.1 degrees Standard Deviation 37.8
Motion - ROM Measurement - Radial Abduction 3 years follow-up	47.5 degrees Standard Deviation 6.1
Motion - ROM Measurement - Radial Abduction 5 years follow-up	43.8 degrees Standard Deviation 9.9

SECONDARY outcome

Timeframe: Pre-operative, 1, 3 and 5 years follow-up

Population: Due to the inclusion of 5 bilateral patients the actual number of participants is 95, but 100 implants were included in the study. The results are indicated per implant number.

The range of motion (ROM) is the extent of movement of a joint and indicates the range through which the joint can be moved. The ROM in palmar abduction is measured while the patients move the thumb perpendicularly to the palm.

Outcome measures

Measure	ARPE Prosthesis n=100 implants Single study patient cohort, including 95 patients (100 implants) receiving the cementless ARPE trapeziometacarpal prosthesis.
Motion - ROM Measurement - Palmar Abduction Pre-operative	43.2 degrees Standard Deviation 5.8
Motion - ROM Measurement - Palmar Abduction 1 year follow-up	48.1 degrees Standard Deviation 6.4
Motion - ROM Measurement - Palmar Abduction 3 years follow-up	47.8 degrees Standard Deviation 5.9
Motion - ROM Measurement - Palmar Abduction 5 years follow-up	43.4 degrees Standard Deviation 8.4

SECONDARY outcome

Timeframe: Pre-operative, 1, 3 and 5 years follow-up

Population: Due to the inclusion of 5 bilateral patients the actual number of participants is 95, but 100 implants were included in the study. The results are indicated per implant number.

EQ-5D is a standardized instrument for measuring the health-related quality of life, which assesses health status in terms of five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each question has five levels of response (no problems, slight problems, moderate problems, severe problems, extreme problems/unable to), which are singularly rated and then combined into a health status score. The health status score ranges from less than 0 (where 0 is the value of a health state equivalent to dead; negative values representing values as worse than dead) to 1 (the value of full health), with higher scores indicating higher health utility.

Outcome measures

Measure	ARPE Prosthesis n=100 implants Single study patient cohort, including 95 patients (100 implants) receiving the cementless ARPE trapeziometacarpal prosthesis.
EQ-5D - Health Status Score Pre-operative	0.4 score on a scale Standard Deviation 0.3
EQ-5D - Health Status Score 1 year follow-up	0.8 score on a scale Standard Deviation 0.3
EQ-5D - Health Status Score 3 year follow-up	0.8 score on a scale Standard Deviation 0.3
EQ-5D - Health Status Score 5 year follow-up	0.8 score on a scale Standard Deviation 0.3

SECONDARY outcome

Timeframe: Pre-operative, 1, 3 and 5 years follow-up

Population: Due to the inclusion of 5 bilateral patients the actual number of participants is 95, but 100 implants were included in the study. The results are indicated per implant number.

The second part of the EQ-5D questionnaire consists of a visual analogue scale (VAS) on which the patient rates his/her perceived health from 0 (the worst imaginable health) to 100 (the best imaginable health).

Outcome measures

Measure	ARPE Prosthesis n=100 implants Single study patient cohort, including 95 patients (100 implants) receiving the cementless ARPE trapeziometacarpal prosthesis.
EQ-5D - VAS Score Pre-operative	72.7 score on a scale Standard Deviation 15.8
EQ-5D - VAS Score 1 year follow-up	74.1 score on a scale Standard Deviation 19.5
EQ-5D - VAS Score 3 years follow-up	77.9 score on a scale Standard Deviation 15.7
EQ-5D - VAS Score 5 years follow-up	76.2 score on a scale Standard Deviation 17.2

SECONDARY outcome

Timeframe: 1, 3 and 5 years follow-up

Population: Due to the inclusion of 5 bilateral patients the actual number of participants is 95, but 100 implants were included in the study. The results are indicated per implant number. There were no radiolucency lines reported for any of the patients included in the study at any time point.

Radiolucency lines are radiolucent gaps visible in the radiographic images between the prosthesis and the bone, which presence is commonly associated with early failure of the implantation, eventually leading to the loosening of the prosthesis. Every radiography taken at each follow-up time point was assessed to evaluate whether there are visible radiolucency lines around the implanted prosthesis and the number of implants with visible radiolucency lines is here reported.

Outcome measures

Measure	ARPE Prosthesis n=100 implants Single study patient cohort, including 95 patients (100 implants) receiving the cementless ARPE trapeziometacarpal prosthesis.
Number of Implants With Visible Radiolucency Line Around the Implanted Prosthesis 1 years follow-up	0 implants
Number of Implants With Visible Radiolucency Line Around the Implanted Prosthesis 3 years follow-up	0 implants
Number of Implants With Visible Radiolucency Line Around the Implanted Prosthesis 5 years follow-up	0 implants

SECONDARY outcome

Timeframe: Pre-operative, 1, 3 and 5 years follow-up

Population: Due to the inclusion of 5 bilateral patients the actual number of participants is 95, but 100 implants were included in the study. The results are indicated per implant number.

The DASH (Disabilities of the Arm, Shoulder and Hand) Questionnaire outcome measure is a 30-item, self-report questionnaire designed to assess the patients' health status during the previous week by asking to rate their ability to perform various daily activities. The questions are grouped in 3 categories: disability, work and sport, of which work and sport are optional.

The score ranges from 0 (no disability) to 100 (most severe disability), with higher scores indicating a greater level of disability and severity, whereas lower scores indicate a lower level of disability.

Outcome measures

Measure	ARPE Prosthesis n=100 implants Single study patient cohort, including 95 patients (100 implants) receiving the cementless ARPE trapeziometacarpal prosthesis.
Hand Function: DASH Questionnaire - Disability Pre-operative	41.7 score on a scale Standard Deviation 17.9
Hand Function: DASH Questionnaire - Disability 1 year follow-up	10.6 score on a scale Standard Deviation 14.3
Hand Function: DASH Questionnaire - Disability 3 year follow-up	10.2 score on a scale Standard Deviation 14.2
Hand Function: DASH Questionnaire - Disability 5 year follow-up	8.5 score on a scale Standard Deviation 11.8

SECONDARY outcome

Timeframe: Pre-operative, 1, 3 and 5 years follow-up

Population: Due to the inclusion of 5 bilateral patients the actual number of participants is 95, but 100 implants were included in the study. The results are indicated per implant number. The Work category is optional.

The DASH (Disabilities of the Arm, Shoulder and Hand) Questionnaire outcome measure is a 30-item, self-report questionnaire designed to assess the patients' health status during the previous week by asking to rate their ability to perform various daily activities. The questions are grouped in 3 categories: disability, work and sport, of which work and sport are optional.

The score ranges from 0 (no disability) to 100 (most severe disability), with higher scores indicating a greater level of disability and severity, whereas lower scores indicate a lower level of disability.

Outcome measures

Measure	ARPE Prosthesis n=100 implants Single study patient cohort, including 95 patients (100 implants) receiving the cementless ARPE trapeziometacarpal prosthesis.
Hand Function: DASH Questionnaire - Work Pre-operative	46.1 score on a scale Standard Deviation 25.9
Hand Function: DASH Questionnaire - Work 1 year follow-up	11.1 score on a scale Standard Deviation 17.2
Hand Function: DASH Questionnaire - Work 3 year follow-up	7.8 score on a scale Standard Deviation 16.5
Hand Function: DASH Questionnaire - Work 5 year follow-up	5.8 score on a scale Standard Deviation 13.5

SECONDARY outcome

Timeframe: Pre-operative, 1, 3 and 5 years follow-up

Population: Due to the inclusion of 5 bilateral patients the actual number of participants is 95, but 100 implants were included in the study. The results are indicated per implant number. The Sports category is optional.

The DASH (Disabilities of the Arm, Shoulder and Hand) Questionnaire outcome measure is a 30-item, self-report questionnaire designed to assess the patients' health status during the previous week by asking to rate their ability to perform various daily activities. The questions are grouped in 3 categories: disability, work and sport, of which work and sport are optional.

The score ranges from 0 (no disability) to 100 (most severe disability), with higher scores indicating a greater level of disability and severity, whereas lower scores indicate a lower level of disability.

Outcome measures

Measure	ARPE Prosthesis n=100 implants Single study patient cohort, including 95 patients (100 implants) receiving the cementless ARPE trapeziometacarpal prosthesis.
Hand Function: DASH Questionnaire - Sport Pre-operative	48.7 score on a scale Standard Deviation 32.4
Hand Function: DASH Questionnaire - Sport 1 year follow-up	6.7 score on a scale Standard Deviation 13.4
Hand Function: DASH Questionnaire - Sport 3 year follow-up	10.1 score on a scale Standard Deviation 21.8
Hand Function: DASH Questionnaire - Sport 5 year follow-up	2.2 score on a scale Standard Deviation 5.8

Adverse Events

ARPE Prosthesis

Serious events: 17 serious events

Other events: 19 other events

Deaths: 0 deaths

Serious adverse events

Measure	ARPE Prosthesis n=95 participants at risk Single study patient cohort, including 95 patients (100 implants) receiving the cementless ARPE trapeziometacarpal prosthesis.
Musculoskeletal and connective tissue disorders Prosthesis luxation	5.3% 5/95 • 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 replacement	2.1% 2/95 • 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.
General disorders Anaphylactic shock	1.1% 1/95 • 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 Discectomy	1.1% 1/95 • 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 Malnutrition	1.1% 1/95 • 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.
Cardiac disorders Heart arrhythmia	1.1% 1/95 • 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) Prostate cancer	1.1% 1/95 • 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 Gonarthrosis	1.1% 1/95 • 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 problems	1.1% 1/95 • 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.
Reproductive system and breast disorders Prostate hypertrophy	1.1% 1/95 • 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) Colon cancer	1.1% 1/95 • 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.
Renal and urinary disorders Bladder prolapse	1.1% 1/95 • 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 Gastric bleeding	1.1% 1/95 • 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 Rizarthrosis	1.1% 1/95 • 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 Cuff tear shoulder	1.1% 1/95 • 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 Fracture of pseudoarthrosis radius	1.1% 1/95 • 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	ARPE Prosthesis n=95 participants at risk Single study patient cohort, including 95 patients (100 implants) receiving the cementless ARPE trapeziometacarpal prosthesis.
Musculoskeletal and connective tissue disorders Thumb pain	3.2% 3/95 • 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.
Musculoskeletal and connective tissue disorders Tenosynovitis	11.6% 11/95 • Number of events 13 • 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 Thumb and/or wrist pain	1.1% 1/95 • 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 Carpal tunnel	4.2% 4/95 • 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.
Infections and infestations Thumb infection	1.1% 1/95 • 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 Arthrosis	1.1% 1/95 • 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 Operations Manager

Zimmer Biomet

Phone: +41 58 85 48210

Email: Emilie.Rohmer@zimmerbiomet.com

Results disclosure agreements

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