Trial Outcomes & Findings for PMCF Study on the Safety, Performance and Clinical Benefits of the DVR Plating System (NCT NCT04653051)

NCT ID: NCT04653051

Last Updated: 2024-11-20

Results Overview

Fracture healing will be evaluated by x-rays and clinical measures (no pain at fracture site)

• Recruitment status: COMPLETED
• Target enrollment: 111 participants
• Primary outcome timeframe: Mean time of 3.8 years after the surgery
• Results posted on: 2024-11-20

Participant Flow

Southampton General Hospital

191 consecutive patients were identified at the Southampton General Hospital. 11 patients died or moved out of the area so they could not be enrolled. So 180 patients were contacted and were asked to consider their study participation. 69 patients were either not reachable within three attempts or declined study participation leaving us with 111 patients enrolled into this study.

Unit of analysis: cases

Participant milestones

Measure	DVR Plating System Single study patient cohort, including 111 participants (115 cases) who meet the inclusion/exclusion criteria and who received the DVR Plating System and have a mean follow-up of 3.8 years
Last Consultation Visit at the Hospital STARTED	111 115
Last Consultation Visit at the Hospital COMPLETED	111 115
Last Consultation Visit at the Hospital NOT COMPLETED	0 0
Follow-up Phone Call STARTED	111 114
Follow-up Phone Call COMPLETED	111 114
Follow-up Phone Call NOT COMPLETED	0 0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

As the retrieval of the demographic data was not always possible the number of cases for the weight differs from the total amount of cases.

Baseline characteristics by cohort

Measure	Subjects Received DVR Plating System n=115 cases Single study patient cohort, including 111 participants (115 cases) who meet the inclusion/exclusion criteria and who received the DVR Plating System and have a mean follow-up of 3.8 years
Age, Continuous	60.1 years STANDARD_DEVIATION 18.5 • n=115 cases
Sex: Female, Male Female	76 cases n=115 cases
Sex: Female, Male Male	39 cases n=115 cases
Region of Enrollment United Kingdom	115 cases n=115 cases
Weight, Continuous	73.8 Kg STANDARD_DEVIATION 17.8 • n=64 cases • As the retrieval of the demographic data was not always possible the number of cases for the weight differs from the total amount of cases.
Height, Continuous	165.8 cm STANDARD_DEVIATION 16.2 • n=52 cases • As the retrieval of the demographic data was not always possible the number of cases for the height differs from the total amount of cases.
Body Mass Index, Continuous	26.3 Kg/m^2 STANDARD_DEVIATION 5.7 • n=49 cases • As the retrieval of the demographic data was not always possible the number of cases for the body mass index differs from the total amount of cases.

PRIMARY outcome

Timeframe: Mean time of 3.8 years after the surgery

Fracture healing will be evaluated by x-rays and clinical measures (no pain at fracture site)

Outcome measures

Measure	DVR Plating System n=115 cases Single study patient cohort, including 111 participants (115 cases) who meet the inclusion/exclusion criteria and who received the DVR Plating System and have a mean follow-up of 3.8 years
Fracture Healing Based on Clinical Measures and X-rays X-ray Evaluation · Fracture/Osteotomy healed	103 cases
Fracture Healing Based on Clinical Measures and X-rays X-ray Evaluation · Fracture/Osteotomy not healed	2 cases
Fracture Healing Based on Clinical Measures and X-rays X-ray Evaluation · Fracture/Osteotomy healing not assessed	10 cases
Fracture Healing Based on Clinical Measures and X-rays Clinical Evaluation · Fracture/Osteotomy healed	114 cases
Fracture Healing Based on Clinical Measures and X-rays Clinical Evaluation · Fracture/Osteotomy not healed	0 cases
Fracture Healing Based on Clinical Measures and X-rays Clinical Evaluation · Fracture/Osteotomy healing not assessed	1 cases

SECONDARY outcome

Timeframe: Mean time of 3.8 years after surgery

Population: complications \[Adverse Events (AEs), Serious Adverse Events (SAEs), Adverse Device Effects (ADEs), Serious Adverse Device Effects (SADEs)\] that occurred in the study cohort during the time of the study

Safety will be assessed by recording and analyzing the incidence and frequency of complications. The complications are classified per ISO 14155 Definitions: Adverse Events (AEs), Serious Adverse Events (SAEs), Adverse Device Effects (ADEs), Serious Adverse Device Effects (SADEs).

.

Outcome measures

Measure	DVR Plating System n=92 complications classified per ISO14155 Single study patient cohort, including 111 participants (115 cases) who meet the inclusion/exclusion criteria and who received the DVR Plating System and have a mean follow-up of 3.8 years
Product Safety Based on Complications Adverse Events (AEs)	77 complications classified per ISO14155
Product Safety Based on Complications Serious Adverse Events (SAEs)	4 complications classified per ISO14155
Product Safety Based on Complications Adverse Device Effects (ADEs)	11 complications classified per ISO14155
Product Safety Based on Complications Serious Adverse Device Effects (SADEs)	0 complications classified per ISO14155

SECONDARY outcome

Timeframe: Mean time of 3.8 years after surgery

Population: In a case the General Wrist Function could not be assessed as the patient is suffering from Kienbock's disease and is experiencing a lot of pain, therefore the General Wrist Function is calculated for 113 cases.

Patients were asked to complete a patient questionnaire (Patient-Rated Wrist Evaluation Score- PRWE)* and a question on their wrist function**

• the PRWE is a self-administered, patient-specific questionnaire that consists of 15 items. It was designed to measure wrist pain and disability in activities of daily living, and consists of two subscales: pain and function. A score of 100 represents the worst functional score, whereas 0 represents no disability

** Patient reported outcome: assessment of fractured wrist comparing to before injury on a scale from 0 to 10, 0 being worst imaginable, and 10 being as good as before the injury.

Outcome measures

Measure	DVR Plating System n=114 cases Single study patient cohort, including 111 participants (115 cases) who meet the inclusion/exclusion criteria and who received the DVR Plating System and have a mean follow-up of 3.8 years
Patient's Outcomes Were Also Assessed PRWE Score	12.8 cases Standard Deviation 17.9
Patient's Outcomes Were Also Assessed General Wrist Function	8.0 cases Standard Deviation 2.1

Adverse Events

111 Subjects Received DVR Plating System With a Mean Follow-up of 3.8 Years

Serious events: 4 serious events

Other events: 59 other events

Deaths: 0 deaths

Serious adverse events

Measure	111 Subjects Received DVR Plating System With a Mean Follow-up of 3.8 Years n=111 participants at risk Single study patient cohort, including 111 participants (115 patients) who meet the inclusion/exclusion criteria and who received the DVR Plating System
Nervous system disorders Altered sensation of the median nerve	0.90% 1/111 • Number of events 1 • Reported Adverse Events (AEs) include events from the date each subject was implanted up to 3.8 years after surgery, when the last follow-up was performed and patients completed the study. Adverse Event Reporting Description Adverse events were collected in an excel database on the tab of Adverse events, 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.
Injury, poisoning and procedural complications Car accident	0.90% 1/111 • Number of events 1 • Reported Adverse Events (AEs) include events from the date each subject was implanted up to 3.8 years after surgery, when the last follow-up was performed and patients completed the study. Adverse Event Reporting Description Adverse events were collected in an excel database on the tab of Adverse events, 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 Reduced mobility	0.90% 1/111 • Number of events 1 • Reported Adverse Events (AEs) include events from the date each subject was implanted up to 3.8 years after surgery, when the last follow-up was performed and patients completed the study. Adverse Event Reporting Description Adverse events were collected in an excel database on the tab of Adverse events, 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.
Vascular disorders Kienbock's disease	0.90% 1/111 • Number of events 1 • Reported Adverse Events (AEs) include events from the date each subject was implanted up to 3.8 years after surgery, when the last follow-up was performed and patients completed the study. Adverse Event Reporting Description Adverse events were collected in an excel database on the tab of Adverse events, 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	111 Subjects Received DVR Plating System With a Mean Follow-up of 3.8 Years n=111 participants at risk Single study patient cohort, including 111 participants (115 patients) who meet the inclusion/exclusion criteria and who received the DVR Plating System
Nervous system disorders Pain due to altered sensation	0.90% 1/111 • Number of events 1 • Reported Adverse Events (AEs) include events from the date each subject was implanted up to 3.8 years after surgery, when the last follow-up was performed and patients completed the study. Adverse Event Reporting Description Adverse events were collected in an excel database on the tab of Adverse events, 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 Plate removal	0.90% 1/111 • Number of events 1 • Reported Adverse Events (AEs) include events from the date each subject was implanted up to 3.8 years after surgery, when the last follow-up was performed and patients completed the study. Adverse Event Reporting Description Adverse events were collected in an excel database on the tab of Adverse events, 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/ arm pain	0.90% 1/111 • Number of events 1 • Reported Adverse Events (AEs) include events from the date each subject was implanted up to 3.8 years after surgery, when the last follow-up was performed and patients completed the study. Adverse Event Reporting Description Adverse events were collected in an excel database on the tab of Adverse events, 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 Pain in wrist	1.8% 2/111 • Number of events 2 • Reported Adverse Events (AEs) include events from the date each subject was implanted up to 3.8 years after surgery, when the last follow-up was performed and patients completed the study. Adverse Event Reporting Description Adverse events were collected in an excel database on the tab of Adverse events, 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.
Product Issues Loose screw	0.90% 1/111 • Number of events 1 • Reported Adverse Events (AEs) include events from the date each subject was implanted up to 3.8 years after surgery, when the last follow-up was performed and patients completed the study. Adverse Event Reporting Description Adverse events were collected in an excel database on the tab of Adverse events, 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 Stiffness and pain	2.7% 3/111 • Number of events 3 • Reported Adverse Events (AEs) include events from the date each subject was implanted up to 3.8 years after surgery, when the last follow-up was performed and patients completed the study. Adverse Event Reporting Description Adverse events were collected in an excel database on the tab of Adverse events, 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 Shooting spasm pains	1.8% 2/111 • Number of events 2 • Reported Adverse Events (AEs) include events from the date each subject was implanted up to 3.8 years after surgery, when the last follow-up was performed and patients completed the study. Adverse Event Reporting Description Adverse events were collected in an excel database on the tab of Adverse events, 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 Rotator cuff impingement	0.90% 1/111 • Number of events 1 • Reported Adverse Events (AEs) include events from the date each subject was implanted up to 3.8 years after surgery, when the last follow-up was performed and patients completed the study. Adverse Event Reporting Description Adverse events were collected in an excel database on the tab of Adverse events, 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 Collapsed joint line	0.90% 1/111 • Number of events 1 • Reported Adverse Events (AEs) include events from the date each subject was implanted up to 3.8 years after surgery, when the last follow-up was performed and patients completed the study. Adverse Event Reporting Description Adverse events were collected in an excel database on the tab of Adverse events, 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 Pain	1.8% 2/111 • Number of events 2 • Reported Adverse Events (AEs) include events from the date each subject was implanted up to 3.8 years after surgery, when the last follow-up was performed and patients completed the study. Adverse Event Reporting Description Adverse events were collected in an excel database on the tab of Adverse events, 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 Mild ache	1.8% 2/111 • Number of events 2 • Reported Adverse Events (AEs) include events from the date each subject was implanted up to 3.8 years after surgery, when the last follow-up was performed and patients completed the study. Adverse Event Reporting Description Adverse events were collected in an excel database on the tab of Adverse events, 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 Intermittent pain and instability	0.90% 1/111 • Number of events 1 • Reported Adverse Events (AEs) include events from the date each subject was implanted up to 3.8 years after surgery, when the last follow-up was performed and patients completed the study. Adverse Event Reporting Description Adverse events were collected in an excel database on the tab of Adverse events, 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 Lower Respiratory Tract Infection (LRTI)	0.90% 1/111 • Number of events 1 • Reported Adverse Events (AEs) include events from the date each subject was implanted up to 3.8 years after surgery, when the last follow-up was performed and patients completed the study. Adverse Event Reporting Description Adverse events were collected in an excel database on the tab of Adverse events, 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.
Immune system disorders Arthritis	3.6% 4/111 • Number of events 4 • Reported Adverse Events (AEs) include events from the date each subject was implanted up to 3.8 years after surgery, when the last follow-up was performed and patients completed the study. Adverse Event Reporting Description Adverse events were collected in an excel database on the tab of Adverse events, 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 Low wrist function	0.90% 1/111 • Number of events 1 • Reported Adverse Events (AEs) include events from the date each subject was implanted up to 3.8 years after surgery, when the last follow-up was performed and patients completed the study. Adverse Event Reporting Description Adverse events were collected in an excel database on the tab of Adverse events, 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.
Injury, poisoning and procedural complications Additional fall	2.7% 3/111 • Number of events 3 • Reported Adverse Events (AEs) include events from the date each subject was implanted up to 3.8 years after surgery, when the last follow-up was performed and patients completed the study. Adverse Event Reporting Description Adverse events were collected in an excel database on the tab of Adverse events, 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.
Product Issues Discomfort and pain	0.90% 1/111 • Number of events 1 • Reported Adverse Events (AEs) include events from the date each subject was implanted up to 3.8 years after surgery, when the last follow-up was performed and patients completed the study. Adverse Event Reporting Description Adverse events were collected in an excel database on the tab of Adverse events, 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.
Injury, poisoning and procedural complications Polytrauma	5.4% 6/111 • Number of events 6 • Reported Adverse Events (AEs) include events from the date each subject was implanted up to 3.8 years after surgery, when the last follow-up was performed and patients completed the study. Adverse Event Reporting Description Adverse events were collected in an excel database on the tab of Adverse events, 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 Aching and pain	0.90% 1/111 • Number of events 1 • Reported Adverse Events (AEs) include events from the date each subject was implanted up to 3.8 years after surgery, when the last follow-up was performed and patients completed the study. Adverse Event Reporting Description Adverse events were collected in an excel database on the tab of Adverse events, 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.
Product Issues Plate removal	2.7% 3/111 • Number of events 3 • Reported Adverse Events (AEs) include events from the date each subject was implanted up to 3.8 years after surgery, when the last follow-up was performed and patients completed the study. Adverse Event Reporting Description Adverse events were collected in an excel database on the tab of Adverse events, 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 Long recovery	0.90% 1/111 • Number of events 1 • Reported Adverse Events (AEs) include events from the date each subject was implanted up to 3.8 years after surgery, when the last follow-up was performed and patients completed the study. Adverse Event Reporting Description Adverse events were collected in an excel database on the tab of Adverse events, 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 Complex Regional Pain Syndrome	0.90% 1/111 • Number of events 1 • Reported Adverse Events (AEs) include events from the date each subject was implanted up to 3.8 years after surgery, when the last follow-up was performed and patients completed the study. Adverse Event Reporting Description Adverse events were collected in an excel database on the tab of Adverse events, 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 Reduced ROM	4.5% 5/111 • Number of events 5 • Reported Adverse Events (AEs) include events from the date each subject was implanted up to 3.8 years after surgery, when the last follow-up was performed and patients completed the study. Adverse Event Reporting Description Adverse events were collected in an excel database on the tab of Adverse events, 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 Pain when lifting heavy objects	0.90% 1/111 • Number of events 1 • Reported Adverse Events (AEs) include events from the date each subject was implanted up to 3.8 years after surgery, when the last follow-up was performed and patients completed the study. Adverse Event Reporting Description Adverse events were collected in an excel database on the tab of Adverse events, 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 Occasional pain and slightly reduced ROM	0.90% 1/111 • Number of events 1 • Reported Adverse Events (AEs) include events from the date each subject was implanted up to 3.8 years after surgery, when the last follow-up was performed and patients completed the study. Adverse Event Reporting Description Adverse events were collected in an excel database on the tab of Adverse events, 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 Numbness	0.90% 1/111 • Number of events 1 • Reported Adverse Events (AEs) include events from the date each subject was implanted up to 3.8 years after surgery, when the last follow-up was performed and patients completed the study. Adverse Event Reporting Description Adverse events were collected in an excel database on the tab of Adverse events, 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 Swollen wrist	0.90% 1/111 • Number of events 1 • Reported Adverse Events (AEs) include events from the date each subject was implanted up to 3.8 years after surgery, when the last follow-up was performed and patients completed the study. Adverse Event Reporting Description Adverse events were collected in an excel database on the tab of Adverse events, 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 Polymyalgia	0.90% 1/111 • Number of events 1 • Reported Adverse Events (AEs) include events from the date each subject was implanted up to 3.8 years after surgery, when the last follow-up was performed and patients completed the study. Adverse Event Reporting Description Adverse events were collected in an excel database on the tab of Adverse events, 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 Shooting nerve pain in wrist	0.90% 1/111 • Number of events 1 • Reported Adverse Events (AEs) include events from the date each subject was implanted up to 3.8 years after surgery, when the last follow-up was performed and patients completed the study. Adverse Event Reporting Description Adverse events were collected in an excel database on the tab of Adverse events, 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 Stitches opened	0.90% 1/111 • Number of events 1 • Reported Adverse Events (AEs) include events from the date each subject was implanted up to 3.8 years after surgery, when the last follow-up was performed and patients completed the study. Adverse Event Reporting Description Adverse events were collected in an excel database on the tab of Adverse events, 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.
Injury, poisoning and procedural complications Bones moving forward	0.90% 1/111 • Number of events 1 • Reported Adverse Events (AEs) include events from the date each subject was implanted up to 3.8 years after surgery, when the last follow-up was performed and patients completed the study. Adverse Event Reporting Description Adverse events were collected in an excel database on the tab of Adverse events, 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 Tingling sensation	1.8% 2/111 • Number of events 2 • Reported Adverse Events (AEs) include events from the date each subject was implanted up to 3.8 years after surgery, when the last follow-up was performed and patients completed the study. Adverse Event Reporting Description Adverse events were collected in an excel database on the tab of Adverse events, 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 Clicking and minor weakness	0.90% 1/111 • Number of events 1 • Reported Adverse Events (AEs) include events from the date each subject was implanted up to 3.8 years after surgery, when the last follow-up was performed and patients completed the study. Adverse Event Reporting Description Adverse events were collected in an excel database on the tab of Adverse events, 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.
Product Issues Thicker wrist	0.90% 1/111 • Number of events 1 • Reported Adverse Events (AEs) include events from the date each subject was implanted up to 3.8 years after surgery, when the last follow-up was performed and patients completed the study. Adverse Event Reporting Description Adverse events were collected in an excel database on the tab of Adverse events, 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.
Product Issues Plate pincing nerve	0.90% 1/111 • Number of events 1 • Reported Adverse Events (AEs) include events from the date each subject was implanted up to 3.8 years after surgery, when the last follow-up was performed and patients completed the study. Adverse Event Reporting Description Adverse events were collected in an excel database on the tab of Adverse events, 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 Loss of power and grip strenght	3.6% 4/111 • Number of events 4 • Reported Adverse Events (AEs) include events from the date each subject was implanted up to 3.8 years after surgery, when the last follow-up was performed and patients completed the study. Adverse Event Reporting Description Adverse events were collected in an excel database on the tab of Adverse events, 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.
Injury, poisoning and procedural complications Concurring spinal injuries	0.90% 1/111 • Number of events 1 • Reported Adverse Events (AEs) include events from the date each subject was implanted up to 3.8 years after surgery, when the last follow-up was performed and patients completed the study. Adverse Event Reporting Description Adverse events were collected in an excel database on the tab of Adverse events, 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.
Product Issues Collapse at fracture site	0.90% 1/111 • Number of events 1 • Reported Adverse Events (AEs) include events from the date each subject was implanted up to 3.8 years after surgery, when the last follow-up was performed and patients completed the study. Adverse Event Reporting Description Adverse events were collected in an excel database on the tab of Adverse events, 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 Back pain	0.90% 1/111 • Number of events 1 • Reported Adverse Events (AEs) include events from the date each subject was implanted up to 3.8 years after surgery, when the last follow-up was performed and patients completed the study. Adverse Event Reporting Description Adverse events were collected in an excel database on the tab of Adverse events, 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.
Product Issues Stiffness and irritation caused by the plate	1.8% 2/111 • Number of events 2 • Reported Adverse Events (AEs) include events from the date each subject was implanted up to 3.8 years after surgery, when the last follow-up was performed and patients completed the study. Adverse Event Reporting Description Adverse events were collected in an excel database on the tab of Adverse events, 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 Dull ache	0.90% 1/111 • Number of events 1 • Reported Adverse Events (AEs) include events from the date each subject was implanted up to 3.8 years after surgery, when the last follow-up was performed and patients completed the study. Adverse Event Reporting Description Adverse events were collected in an excel database on the tab of Adverse events, 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 weakness	0.90% 1/111 • Number of events 1 • Reported Adverse Events (AEs) include events from the date each subject was implanted up to 3.8 years after surgery, when the last follow-up was performed and patients completed the study. Adverse Event Reporting Description Adverse events were collected in an excel database on the tab of Adverse events, 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 Enlarged scar	0.90% 1/111 • Number of events 1 • Reported Adverse Events (AEs) include events from the date each subject was implanted up to 3.8 years after surgery, when the last follow-up was performed and patients completed the study. Adverse Event Reporting Description Adverse events were collected in an excel database on the tab of Adverse events, 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 Pins and needles feeling	1.8% 2/111 • Number of events 2 • Reported Adverse Events (AEs) include events from the date each subject was implanted up to 3.8 years after surgery, when the last follow-up was performed and patients completed the study. Adverse Event Reporting Description Adverse events were collected in an excel database on the tab of Adverse events, 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 Pain combined with stiffness	1.8% 2/111 • Number of events 2 • Reported Adverse Events (AEs) include events from the date each subject was implanted up to 3.8 years after surgery, when the last follow-up was performed and patients completed the study. Adverse Event Reporting Description Adverse events were collected in an excel database on the tab of Adverse events, 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 Pain when performing repeated wrist movements	0.90% 1/111 • Number of events 1 • Reported Adverse Events (AEs) include events from the date each subject was implanted up to 3.8 years after surgery, when the last follow-up was performed and patients completed the study. Adverse Event Reporting Description Adverse events were collected in an excel database on the tab of Adverse events, 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 Reduced strength	1.8% 2/111 • Number of events 2 • Reported Adverse Events (AEs) include events from the date each subject was implanted up to 3.8 years after surgery, when the last follow-up was performed and patients completed the study. Adverse Event Reporting Description Adverse events were collected in an excel database on the tab of Adverse events, 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.
Injury, poisoning and procedural complications Inpatient fall	0.90% 1/111 • Number of events 1 • Reported Adverse Events (AEs) include events from the date each subject was implanted up to 3.8 years after surgery, when the last follow-up was performed and patients completed the study. Adverse Event Reporting Description Adverse events were collected in an excel database on the tab of Adverse events, 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

Georgia Tsapara

Zimmer Biomet

Phone: +41 79 94 54936

Email: georgia.tsapara@zimmerbiomet.com

Results disclosure agreements

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

Restriction type: GT60