Trial Outcomes & Findings for PMCF Study on the Safety, Performance and Clinical Benefits Data of the Zimmer® Plates and Screws System (NCT NCT05215613)
NCT ID: NCT05215613
Last Updated: 2025-02-25
Results Overview
Performance will be assessed by analyzing fracture healing radiographically or clinically. Timepoints at which the data will be collected will be summarized through means.
Recruitment status
COMPLETED
Target enrollment
57 participants
Primary outcome timeframe
At last consultation visit either at minimum 6 months post-operative by radiographic assessment or, if no x-rays available, by clinical assessment at the follow-up phone call at minimum 1 year postoperative.
Results posted on
2025-02-25
Participant Flow
1 patient's fracture was revised with the study device and was therefore enrolled twice as 2 separate cases in the study, as two study devices were used.
Unit of analysis: Fracture
Participant milestones
| Measure |
Patients Implanted With a Zimmer® Plates and Screws System Diaphysis Plate
30 participants (31 cases) who meet the inclusion and none of the exclusion criteria and who received the Zimmer® Plates and Screws System in the Diaphysis.
|
Patients Implanted With a Zimmer® Plates and Screws System Proximal Tibia Plate
26 participants (26 cases) who meet the inclusion and none of the exclusion criteria and who received the Zimmer® Plates and Screws System in the Proximal Tibia.
|
|---|---|---|
|
Overall Study
STARTED
|
30 31
|
26 26
|
|
Overall Study
COMPLETED
|
30 31
|
26 26
|
|
Overall Study
NOT COMPLETED
|
0 0
|
0 0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Patients Implanted With a Zimmer® Plates and Screws System Diaphysis Plate
n=31 Fractures
30 participants (31 cases) who meet the inclusion and none of the exclusion criteria and who received the Zimmer® Plates and Screws System in the Diaphysis.
|
Patients Implanted With a Zimmer® Plates and Screws System Proximal Tibia Plate
n=26 Fractures
26 participants (26 cases) who meet the inclusion and none of the exclusion criteria and who received the Zimmer® Plates and Screws System in the Proximal Tibia.
|
Total
n=57 Fractures
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
39.9 years
STANDARD_DEVIATION 19.6 • n=31 Fractures
|
36.2 years
STANDARD_DEVIATION 13.6 • n=26 Fractures
|
38.2 years
STANDARD_DEVIATION 17.1 • n=57 Fractures
|
|
Sex: Female, Male
Female
|
9 Fractures
n=31 Fractures
|
10 Fractures
n=26 Fractures
|
19 Fractures
n=57 Fractures
|
|
Sex: Female, Male
Male
|
22 Fractures
n=31 Fractures
|
16 Fractures
n=26 Fractures
|
38 Fractures
n=57 Fractures
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Concomitant Diseases
None
|
25 Fractures
n=31 Fractures
|
17 Fractures
n=26 Fractures
|
42 Fractures
n=57 Fractures
|
|
Concomitant Diseases
Cardiac / Respiratory Disease and Hypertension
|
2 Fractures
n=31 Fractures
|
1 Fractures
n=26 Fractures
|
3 Fractures
n=57 Fractures
|
|
Concomitant Diseases
Vascular Disease and Hypertension
|
1 Fractures
n=31 Fractures
|
1 Fractures
n=26 Fractures
|
2 Fractures
n=57 Fractures
|
|
Concomitant Diseases
Congenital Hip Dysplasia
|
0 Fractures
n=31 Fractures
|
2 Fractures
n=26 Fractures
|
2 Fractures
n=57 Fractures
|
|
Concomitant Diseases
Vascular Disease and Venous Insufficiency Right Lower Limb
|
0 Fractures
n=31 Fractures
|
1 Fractures
n=26 Fractures
|
1 Fractures
n=57 Fractures
|
|
Concomitant Diseases
Hypothyroidism
|
0 Fractures
n=31 Fractures
|
1 Fractures
n=26 Fractures
|
1 Fractures
n=57 Fractures
|
|
Concomitant Diseases
Osteogenesis Imperfecta
|
0 Fractures
n=31 Fractures
|
1 Fractures
n=26 Fractures
|
1 Fractures
n=57 Fractures
|
|
Concomitant Diseases
Cardiac / Respiratory Disease, Hypertension and Hypercholesterolemia
|
1 Fractures
n=31 Fractures
|
0 Fractures
n=26 Fractures
|
1 Fractures
n=57 Fractures
|
|
Concomitant Diseases
Diabetes and Hypercholesterolemia
|
1 Fractures
n=31 Fractures
|
0 Fractures
n=26 Fractures
|
1 Fractures
n=57 Fractures
|
|
Concomitant Diseases
Cardiac / Respiratory Disease, Hypertension, Hypercholesterolemia and Diabetes
|
1 Fractures
n=31 Fractures
|
0 Fractures
n=26 Fractures
|
1 Fractures
n=57 Fractures
|
|
Concomitant Diseases
Prothrombin Gene Mutation
|
0 Fractures
n=31 Fractures
|
1 Fractures
n=26 Fractures
|
1 Fractures
n=57 Fractures
|
|
Concomitant Diseases
Previous Open Fracture and Internal Fixation Right Femur and Patella 1 year earlier
|
0 Fractures
n=31 Fractures
|
1 Fractures
n=26 Fractures
|
1 Fractures
n=57 Fractures
|
|
Confounding fractures for bone union
None
|
22 Fractures
n=31 Fractures
|
21 Fractures
n=26 Fractures
|
43 Fractures
n=57 Fractures
|
|
Confounding fractures for bone union
Smoking
|
5 Fractures
n=31 Fractures
|
4 Fractures
n=26 Fractures
|
9 Fractures
n=57 Fractures
|
|
Confounding fractures for bone union
Obesity
|
2 Fractures
n=31 Fractures
|
0 Fractures
n=26 Fractures
|
2 Fractures
n=57 Fractures
|
|
Confounding fractures for bone union
Smoking and Obesity
|
1 Fractures
n=31 Fractures
|
0 Fractures
n=26 Fractures
|
1 Fractures
n=57 Fractures
|
|
Confounding fractures for bone union
Obesity and Leri-Weill Dischondrosteosis
|
0 Fractures
n=31 Fractures
|
1 Fractures
n=26 Fractures
|
1 Fractures
n=57 Fractures
|
|
Confounding fractures for bone union
Patient with paralized lower limbs following polio
|
1 Fractures
n=31 Fractures
|
0 Fractures
n=26 Fractures
|
1 Fractures
n=57 Fractures
|
|
Fracture Cause
Domestic accident
|
1 Fractures
n=31 Fractures
|
9 Fractures
n=26 Fractures
|
10 Fractures
n=57 Fractures
|
|
Fracture Cause
Road traffic accident
|
5 Fractures
n=31 Fractures
|
8 Fractures
n=26 Fractures
|
13 Fractures
n=57 Fractures
|
|
Fracture Cause
Non-union
|
11 Fractures
n=31 Fractures
|
3 Fractures
n=26 Fractures
|
14 Fractures
n=57 Fractures
|
|
Fracture Cause
Domestic accident and Fall
|
1 Fractures
n=31 Fractures
|
0 Fractures
n=26 Fractures
|
1 Fractures
n=57 Fractures
|
|
Fracture Cause
Non-union and Pseudarthrosis after osteotomy in hip dysplasia
|
2 Fractures
n=31 Fractures
|
0 Fractures
n=26 Fractures
|
2 Fractures
n=57 Fractures
|
|
Fracture Cause
Fall
|
4 Fractures
n=31 Fractures
|
0 Fractures
n=26 Fractures
|
4 Fractures
n=57 Fractures
|
|
Fracture Cause
Trauma
|
2 Fractures
n=31 Fractures
|
0 Fractures
n=26 Fractures
|
2 Fractures
n=57 Fractures
|
|
Fracture Cause
Distorsion Trauma
|
2 Fractures
n=31 Fractures
|
0 Fractures
n=26 Fractures
|
2 Fractures
n=57 Fractures
|
|
Fracture Cause
Crush Trauma
|
1 Fractures
n=31 Fractures
|
0 Fractures
n=26 Fractures
|
1 Fractures
n=57 Fractures
|
|
Fracture Cause
New fracture on previous synthesis
|
1 Fractures
n=31 Fractures
|
0 Fractures
n=26 Fractures
|
1 Fractures
n=57 Fractures
|
|
Fracture Cause
Non-union and Nail breakage
|
1 Fractures
n=31 Fractures
|
0 Fractures
n=26 Fractures
|
1 Fractures
n=57 Fractures
|
|
Fracture Cause
Winter Sports accident
|
0 Fractures
n=31 Fractures
|
5 Fractures
n=26 Fractures
|
5 Fractures
n=57 Fractures
|
|
Fracture Cause
Correction following reduction and osteosynthesis performed at another center
|
0 Fractures
n=31 Fractures
|
1 Fractures
n=26 Fractures
|
1 Fractures
n=57 Fractures
|
|
Open or Closed Fracture
Closed
|
31 Fractures
n=31 Fractures
|
26 Fractures
n=26 Fractures
|
57 Fractures
n=57 Fractures
|
|
Open or Closed Fracture
Open
|
0 Fractures
n=31 Fractures
|
0 Fractures
n=26 Fractures
|
0 Fractures
n=57 Fractures
|
|
Existence of Additional Fractures / Injuries
Yes
|
4 Fractures
n=31 Fractures
|
0 Fractures
n=26 Fractures
|
4 Fractures
n=57 Fractures
|
|
Existence of Additional Fractures / Injuries
No
|
27 Fractures
n=31 Fractures
|
26 Fractures
n=26 Fractures
|
53 Fractures
n=57 Fractures
|
|
AO/OTA Fracture Classification
2U2A2
|
1 Fractures
n=31 Fractures
|
0 Fractures
n=26 Fractures
|
1 Fractures
n=57 Fractures
|
|
AO/OTA Fracture Classification
4F2B1
|
2 Fractures
n=31 Fractures
|
0 Fractures
n=26 Fractures
|
2 Fractures
n=57 Fractures
|
|
AO/OTA Fracture Classification
4F2B2
|
1 Fractures
n=31 Fractures
|
0 Fractures
n=26 Fractures
|
1 Fractures
n=57 Fractures
|
|
AO/OTA Fracture Classification
12A1
|
1 Fractures
n=31 Fractures
|
0 Fractures
n=26 Fractures
|
1 Fractures
n=57 Fractures
|
|
AO/OTA Fracture Classification
12A2
|
3 Fractures
n=31 Fractures
|
0 Fractures
n=26 Fractures
|
3 Fractures
n=57 Fractures
|
|
AO/OTA Fracture Classification
12A3
|
3 Fractures
n=31 Fractures
|
0 Fractures
n=26 Fractures
|
3 Fractures
n=57 Fractures
|
|
AO/OTA Fracture Classification
12B2
|
2 Fractures
n=31 Fractures
|
0 Fractures
n=26 Fractures
|
2 Fractures
n=57 Fractures
|
|
AO/OTA Fracture Classification
12B3
|
1 Fractures
n=31 Fractures
|
0 Fractures
n=26 Fractures
|
1 Fractures
n=57 Fractures
|
|
AO/OTA Fracture Classification
32A1
|
4 Fractures
n=31 Fractures
|
0 Fractures
n=26 Fractures
|
4 Fractures
n=57 Fractures
|
|
AO/OTA Fracture Classification
32A2
|
3 Fractures
n=31 Fractures
|
0 Fractures
n=26 Fractures
|
3 Fractures
n=57 Fractures
|
|
AO/OTA Fracture Classification
32A3
|
1 Fractures
n=31 Fractures
|
0 Fractures
n=26 Fractures
|
1 Fractures
n=57 Fractures
|
|
AO/OTA Fracture Classification
32B2
|
1 Fractures
n=31 Fractures
|
0 Fractures
n=26 Fractures
|
1 Fractures
n=57 Fractures
|
|
AO/OTA Fracture Classification
32B3
|
1 Fractures
n=31 Fractures
|
0 Fractures
n=26 Fractures
|
1 Fractures
n=57 Fractures
|
|
AO/OTA Fracture Classification
32C2
|
1 Fractures
n=31 Fractures
|
0 Fractures
n=26 Fractures
|
1 Fractures
n=57 Fractures
|
|
AO/OTA Fracture Classification
42A1
|
2 Fractures
n=31 Fractures
|
0 Fractures
n=26 Fractures
|
2 Fractures
n=57 Fractures
|
|
AO/OTA Fracture Classification
42B1
|
1 Fractures
n=31 Fractures
|
0 Fractures
n=26 Fractures
|
1 Fractures
n=57 Fractures
|
|
AO/OTA Fracture Classification
42B3
|
1 Fractures
n=31 Fractures
|
0 Fractures
n=26 Fractures
|
1 Fractures
n=57 Fractures
|
|
AO/OTA Fracture Classification
87A2
|
2 Fractures
n=31 Fractures
|
0 Fractures
n=26 Fractures
|
2 Fractures
n=57 Fractures
|
|
AO/OTA Fracture Classification
41A
|
0 Fractures
n=31 Fractures
|
2 Fractures
n=26 Fractures
|
2 Fractures
n=57 Fractures
|
|
AO/OTA Fracture Classification
41A1.2
|
0 Fractures
n=31 Fractures
|
1 Fractures
n=26 Fractures
|
1 Fractures
n=57 Fractures
|
|
AO/OTA Fracture Classification
41A2
|
0 Fractures
n=31 Fractures
|
2 Fractures
n=26 Fractures
|
2 Fractures
n=57 Fractures
|
|
AO/OTA Fracture Classification
41A3
|
0 Fractures
n=31 Fractures
|
1 Fractures
n=26 Fractures
|
1 Fractures
n=57 Fractures
|
|
AO/OTA Fracture Classification
41A2.1
|
0 Fractures
n=31 Fractures
|
1 Fractures
n=26 Fractures
|
1 Fractures
n=57 Fractures
|
|
AO/OTA Fracture Classification
41A2.2
|
0 Fractures
n=31 Fractures
|
7 Fractures
n=26 Fractures
|
7 Fractures
n=57 Fractures
|
|
AO/OTA Fracture Classification
41A2.3
|
0 Fractures
n=31 Fractures
|
3 Fractures
n=26 Fractures
|
3 Fractures
n=57 Fractures
|
|
AO/OTA Fracture Classification
41A3.2
|
0 Fractures
n=31 Fractures
|
1 Fractures
n=26 Fractures
|
1 Fractures
n=57 Fractures
|
|
AO/OTA Fracture Classification
41A3.3
|
0 Fractures
n=31 Fractures
|
1 Fractures
n=26 Fractures
|
1 Fractures
n=57 Fractures
|
|
AO/OTA Fracture Classification
41B1.1
|
0 Fractures
n=31 Fractures
|
2 Fractures
n=26 Fractures
|
2 Fractures
n=57 Fractures
|
|
AO/OTA Fracture Classification
41B1.2
|
0 Fractures
n=31 Fractures
|
1 Fractures
n=26 Fractures
|
1 Fractures
n=57 Fractures
|
|
AO/OTA Fracture Classification
41B2.1
|
0 Fractures
n=31 Fractures
|
1 Fractures
n=26 Fractures
|
1 Fractures
n=57 Fractures
|
|
AO/OTA Fracture Classification
41B3.1
|
0 Fractures
n=31 Fractures
|
1 Fractures
n=26 Fractures
|
1 Fractures
n=57 Fractures
|
|
AO/OTA Fracture Classification
41C1
|
0 Fractures
n=31 Fractures
|
1 Fractures
n=26 Fractures
|
1 Fractures
n=57 Fractures
|
|
AO/OTA Fracture Classification
41C3.3
|
0 Fractures
n=31 Fractures
|
1 Fractures
n=26 Fractures
|
1 Fractures
n=57 Fractures
|
|
Operated Side
Left
|
16 Fractures
n=31 Fractures
|
13 Fractures
n=26 Fractures
|
29 Fractures
n=57 Fractures
|
|
Operated Side
Right
|
15 Fractures
n=31 Fractures
|
13 Fractures
n=26 Fractures
|
28 Fractures
n=57 Fractures
|
|
Length of Hospital Stay
|
4.3 days
STANDARD_DEVIATION 2.6 • n=31 Fractures
|
4.2 days
STANDARD_DEVIATION 2.2 • n=26 Fractures
|
4.2 days
STANDARD_DEVIATION 2.4 • n=57 Fractures
|
PRIMARY outcome
Timeframe: At last consultation visit either at minimum 6 months post-operative by radiographic assessment or, if no x-rays available, by clinical assessment at the follow-up phone call at minimum 1 year postoperative.Performance will be assessed by analyzing fracture healing radiographically or clinically. Timepoints at which the data will be collected will be summarized through means.
Outcome measures
| Measure |
Patients Implanted With a Zimmer® Plates and Screws System Diaphysis Plate
n=31 Fractures
30 participants (31 cases) who meet the inclusion and none of the exclusion criteria and who received the Zimmer® Plates and Screws System in the Diaphysis.
|
Patients Implanted With a Zimmer® Plates and Screws System Proximal Tibia Plate
n=26 Fractures
26 participants (26 cases) who meet the inclusion and none of the exclusion criteria and who received the Zimmer® Plates and Screws System in the Proximal Tibia.
|
|---|---|---|
|
Performance: Fracture Healing
Fracture healed
|
29 Fractures
|
26 Fractures
|
|
Performance: Fracture Healing
Fracture not healed
|
2 Fractures
|
0 Fractures
|
SECONDARY outcome
Timeframe: At operative evaluation, immediate post-operative evaluation, last consultation visit at minimum 6 months post-operative and at the follow-up phone call at minimum 1 year postoperative.Safety will be assessed by recording and analyzing the incidence and frequency of complications and adverse events. Timepoints at which the data will be collected will be summarized through means.
Outcome measures
| Measure |
Patients Implanted With a Zimmer® Plates and Screws System Diaphysis Plate
n=31 Participants
30 participants (31 cases) who meet the inclusion and none of the exclusion criteria and who received the Zimmer® Plates and Screws System in the Diaphysis.
|
Patients Implanted With a Zimmer® Plates and Screws System Proximal Tibia Plate
n=26 Participants
26 participants (26 cases) who meet the inclusion and none of the exclusion criteria and who received the Zimmer® Plates and Screws System in the Proximal Tibia.
|
|---|---|---|
|
Product Safety (Number of Adverse Events, Serious Adverse Events, Adverse Device Effects and Serious Adverse Device Effects)
Adverse Events (AEs)
|
0 Participants
|
3 Participants
|
|
Product Safety (Number of Adverse Events, Serious Adverse Events, Adverse Device Effects and Serious Adverse Device Effects)
Serious Adverse Events (SAEs)
|
0 Participants
|
3 Participants
|
|
Product Safety (Number of Adverse Events, Serious Adverse Events, Adverse Device Effects and Serious Adverse Device Effects)
Adverse Device Effects (ADEs)
|
0 Participants
|
0 Participants
|
|
Product Safety (Number of Adverse Events, Serious Adverse Events, Adverse Device Effects and Serious Adverse Device Effects)
Serious Adverse Device Effects (SADEs)
|
2 Participants
|
2 Participants
|
|
Product Safety (Number of Adverse Events, Serious Adverse Events, Adverse Device Effects and Serious Adverse Device Effects)
No Adverse Events
|
29 Participants
|
18 Participants
|
SECONDARY outcome
Timeframe: Final follow-up visit at minimum 1 year postoperative.Population: Patients implanted with the device in the Proximal Tibia.
Assessment of patient-reported outcome measures (PROMs):The Lysholm Knee Scoring Scale is an outcome measure addressing the following 8 symptoms; instability (25 points), pain (25 points), locking (15 points), swelling (10 points), stair climbing (10 points), limp (5 points), support (5 points), and squatting (5 points). Each of the 8 metrics uses different scoring systems. The total score is the sum of the 8 individual responses. Scores range from 0 (worse disability) to 100 (less disability).
Outcome measures
| Measure |
Patients Implanted With a Zimmer® Plates and Screws System Diaphysis Plate
n=26 Participants
30 participants (31 cases) who meet the inclusion and none of the exclusion criteria and who received the Zimmer® Plates and Screws System in the Diaphysis.
|
Patients Implanted With a Zimmer® Plates and Screws System Proximal Tibia Plate
26 participants (26 cases) who meet the inclusion and none of the exclusion criteria and who received the Zimmer® Plates and Screws System in the Proximal Tibia.
|
|---|---|---|
|
Tegner Lysholm Knee Score (Proximal Tibia)
|
87.4 Score on a scale
Standard Deviation 19.0
|
—
|
SECONDARY outcome
Timeframe: Final follow-up visit at minimum 1 year postoperative.Population: No cases implanted with a Zimmer® Plates and Screws Proximal Humerus Plate were enrolled and analyzed in this study.
Assessment of patient-reported outcome measures (PROMs): The Oxford Shoulder Score (OSS) is a patient-reported outcome questionnaire that was developed to specifically assess the patient's perspective of outcome following TSA. The OSS consists of twelve questions covering function and pain associated with the shoulder. To calculate the total score, each question is scored from 5 (worst outcome) to 0 (best outcome) and the sum of all 12 items is reported with a maximum of 60, representing the worst score possible.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Final follow-up visit at minimum 1 year postoperative.Population: Patients implanted with the device in the Diaphysis.
Assessment of patient-reported outcome measures (PROMs): The EuroQol fivedimensional Health Questionnaire (EQ-5D) is a standardized instrument widely used to measure health status. It is a self-reported assessment about the patient's quality of life composed of two parts: a questionnaire and a visual analogue scale (VAS), the highest score is 100 and the lowest score is 0. The questionnaire includes 5 questions referring to mobility, self-care, daily activities, pain/discomfort and anxiety/depression. Each question can be answered in five ways, indicating no, slight, moderate, severe problems or inability to complete the task. In the derived EQ-5D-5L score, the highest score is 1 and the lowest score is -0.573.
Outcome measures
| Measure |
Patients Implanted With a Zimmer® Plates and Screws System Diaphysis Plate
n=29 Participants
30 participants (31 cases) who meet the inclusion and none of the exclusion criteria and who received the Zimmer® Plates and Screws System in the Diaphysis.
|
Patients Implanted With a Zimmer® Plates and Screws System Proximal Tibia Plate
26 participants (26 cases) who meet the inclusion and none of the exclusion criteria and who received the Zimmer® Plates and Screws System in the Proximal Tibia.
|
|---|---|---|
|
EuroQol Five-dimensional Health Questionnaire (EQ-5D-5L) (Diaphysis)
EQ-5D-5L Profile
|
0.70 Score on a scale
Standard Deviation 0.30
|
—
|
|
EuroQol Five-dimensional Health Questionnaire (EQ-5D-5L) (Diaphysis)
Health State / VAS
|
80.7 Score on a scale
Standard Deviation 20.9
|
—
|
Adverse Events
Patients Implanted With a Zimmer® Plates and Screws System Diaphysis Plate
Serious events: 2 serious events
Other events: 0 other events
Deaths: 0 deaths
Patients Implanted With a Zimmer® Plates and Screws System Proximal Tibia Plate
Serious events: 5 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Patients Implanted With a Zimmer® Plates and Screws System Diaphysis Plate
n=30 participants at risk
30 participants (31 cases) who meet the inclusion and none of the exclusion criteria and who received the Zimmer® Plates and Screws System in the Diaphysis.
|
Patients Implanted With a Zimmer® Plates and Screws System Proximal Tibia Plate
n=26 participants at risk
26 participants (26 cases) who meet the inclusion and none of the exclusion criteria and who received the Zimmer® Plates and Screws System in the Proximal Tibia.
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Pseudarthrosis
|
3.3%
1/30 • Number of events 1 • Reported Adverse Events (AEs) include events from the date each subject was implanted up to 14.6 years after surgery, when the last follow-up was performed and patients completed the study.
Adverse Events were collected in an Excel Spreadsheet, which gathered information of the date of occurrence, the nature of the adverse event, whether the device was involved, which treatment was used and the treatment outcome. No case was enrolled in the proximal humerus group and consequently no Adverse Events were reported in this group.
|
0.00%
0/26 • Reported Adverse Events (AEs) include events from the date each subject was implanted up to 14.6 years after surgery, when the last follow-up was performed and patients completed the study.
Adverse Events were collected in an Excel Spreadsheet, which gathered information of the date of occurrence, the nature of the adverse event, whether the device was involved, which treatment was used and the treatment outcome. No case was enrolled in the proximal humerus group and consequently no Adverse Events were reported in this group.
|
|
Musculoskeletal and connective tissue disorders
Failure of device and new fracture
|
3.3%
1/30 • Number of events 1 • Reported Adverse Events (AEs) include events from the date each subject was implanted up to 14.6 years after surgery, when the last follow-up was performed and patients completed the study.
Adverse Events were collected in an Excel Spreadsheet, which gathered information of the date of occurrence, the nature of the adverse event, whether the device was involved, which treatment was used and the treatment outcome. No case was enrolled in the proximal humerus group and consequently no Adverse Events were reported in this group.
|
0.00%
0/26 • Reported Adverse Events (AEs) include events from the date each subject was implanted up to 14.6 years after surgery, when the last follow-up was performed and patients completed the study.
Adverse Events were collected in an Excel Spreadsheet, which gathered information of the date of occurrence, the nature of the adverse event, whether the device was involved, which treatment was used and the treatment outcome. No case was enrolled in the proximal humerus group and consequently no Adverse Events were reported in this group.
|
|
Musculoskeletal and connective tissue disorders
Valgus knee deviation
|
0.00%
0/30 • Reported Adverse Events (AEs) include events from the date each subject was implanted up to 14.6 years after surgery, when the last follow-up was performed and patients completed the study.
Adverse Events were collected in an Excel Spreadsheet, which gathered information of the date of occurrence, the nature of the adverse event, whether the device was involved, which treatment was used and the treatment outcome. No case was enrolled in the proximal humerus group and consequently no Adverse Events were reported in this group.
|
3.8%
1/26 • Number of events 1 • Reported Adverse Events (AEs) include events from the date each subject was implanted up to 14.6 years after surgery, when the last follow-up was performed and patients completed the study.
Adverse Events were collected in an Excel Spreadsheet, which gathered information of the date of occurrence, the nature of the adverse event, whether the device was involved, which treatment was used and the treatment outcome. No case was enrolled in the proximal humerus group and consequently no Adverse Events were reported in this group.
|
|
Infections and infestations
Infection
|
0.00%
0/30 • Reported Adverse Events (AEs) include events from the date each subject was implanted up to 14.6 years after surgery, when the last follow-up was performed and patients completed the study.
Adverse Events were collected in an Excel Spreadsheet, which gathered information of the date of occurrence, the nature of the adverse event, whether the device was involved, which treatment was used and the treatment outcome. No case was enrolled in the proximal humerus group and consequently no Adverse Events were reported in this group.
|
7.7%
2/26 • Number of events 2 • Reported Adverse Events (AEs) include events from the date each subject was implanted up to 14.6 years after surgery, when the last follow-up was performed and patients completed the study.
Adverse Events were collected in an Excel Spreadsheet, which gathered information of the date of occurrence, the nature of the adverse event, whether the device was involved, which treatment was used and the treatment outcome. No case was enrolled in the proximal humerus group and consequently no Adverse Events were reported in this group.
|
|
Musculoskeletal and connective tissue disorders
New accident with a multifragmented fracture of the proximal tibia
|
0.00%
0/30 • Reported Adverse Events (AEs) include events from the date each subject was implanted up to 14.6 years after surgery, when the last follow-up was performed and patients completed the study.
Adverse Events were collected in an Excel Spreadsheet, which gathered information of the date of occurrence, the nature of the adverse event, whether the device was involved, which treatment was used and the treatment outcome. No case was enrolled in the proximal humerus group and consequently no Adverse Events were reported in this group.
|
3.8%
1/26 • Number of events 1 • Reported Adverse Events (AEs) include events from the date each subject was implanted up to 14.6 years after surgery, when the last follow-up was performed and patients completed the study.
Adverse Events were collected in an Excel Spreadsheet, which gathered information of the date of occurrence, the nature of the adverse event, whether the device was involved, which treatment was used and the treatment outcome. No case was enrolled in the proximal humerus group and consequently no Adverse Events were reported in this group.
|
|
Blood and lymphatic system disorders
Continued postoperative blood loss from the surgical wound
|
0.00%
0/30 • Reported Adverse Events (AEs) include events from the date each subject was implanted up to 14.6 years after surgery, when the last follow-up was performed and patients completed the study.
Adverse Events were collected in an Excel Spreadsheet, which gathered information of the date of occurrence, the nature of the adverse event, whether the device was involved, which treatment was used and the treatment outcome. No case was enrolled in the proximal humerus group and consequently no Adverse Events were reported in this group.
|
3.8%
1/26 • Number of events 1 • Reported Adverse Events (AEs) include events from the date each subject was implanted up to 14.6 years after surgery, when the last follow-up was performed and patients completed the study.
Adverse Events were collected in an Excel Spreadsheet, which gathered information of the date of occurrence, the nature of the adverse event, whether the device was involved, which treatment was used and the treatment outcome. No case was enrolled in the proximal humerus group and consequently no Adverse Events were reported in this group.
|
Other adverse events
| Measure |
Patients Implanted With a Zimmer® Plates and Screws System Diaphysis Plate
n=30 participants at risk
30 participants (31 cases) who meet the inclusion and none of the exclusion criteria and who received the Zimmer® Plates and Screws System in the Diaphysis.
|
Patients Implanted With a Zimmer® Plates and Screws System Proximal Tibia Plate
n=26 participants at risk
26 participants (26 cases) who meet the inclusion and none of the exclusion criteria and who received the Zimmer® Plates and Screws System in the Proximal Tibia.
|
|---|---|---|
|
Blood and lymphatic system disorders
Postoperative anemia
|
0.00%
0/30 • Reported Adverse Events (AEs) include events from the date each subject was implanted up to 14.6 years after surgery, when the last follow-up was performed and patients completed the study.
Adverse Events were collected in an Excel Spreadsheet, which gathered information of the date of occurrence, the nature of the adverse event, whether the device was involved, which treatment was used and the treatment outcome. No case was enrolled in the proximal humerus group and consequently no Adverse Events were reported in this group.
|
7.7%
2/26 • Number of events 2 • Reported Adverse Events (AEs) include events from the date each subject was implanted up to 14.6 years after surgery, when the last follow-up was performed and patients completed the study.
Adverse Events were collected in an Excel Spreadsheet, which gathered information of the date of occurrence, the nature of the adverse event, whether the device was involved, which treatment was used and the treatment outcome. No case was enrolled in the proximal humerus group and consequently no Adverse Events were reported in this group.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60