Trial Outcomes & Findings for Triathlon Tritanium Cone Augments Outcomes Study (NCT NCT02521103)
NCT ID: NCT02521103
Last Updated: 2026-06-01
Results Overview
The primary efficacy parameter is the revision/removal of femoral cone augment or tibial cone augment for aseptic loosening at 2 years postoperative. Success at 2 years is defined as no incidence of revision/removal of femoral or tibial cone augment for aseptic loosening within 2 years.
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
NA
Target enrollment
254 participants
Primary outcome timeframe
2 year
Results posted on
2026-06-01
Participant Flow
There were 254 participants / 259 cases that were enrolled in the study (this includes 5 bilateral participants).
Of the 254 participants (259 cases) enrolled, 64 participants (65 cases) were censored from the analysis, per the Sponsor's internal guidelines. Therefore,190 participants (194 cases) who did receive the study device and met protocol criteria, were followed. Those applicable data are reflected in this record.
Unit of analysis: cases
Participant milestones
| Measure |
Triathlon Tritanium Cone Augments
Cases who receive the Triathlon TS Total Knee System with at least one Triathlon Tritanium Cone Augment
Triathlon Tritanium Cone Augments: The Triathlon Tritanium Cone Augments are an extension of the Triathlon Total Stabilizer (TS) system, intended to be used as an optional accessory component in revision TKA
|
|---|---|
|
Overall Study
STARTED
|
254 259
|
|
Overall Study
COMPLETED
|
135 139
|
|
Overall Study
NOT COMPLETED
|
119 120
|
Reasons for withdrawal
| Measure |
Triathlon Tritanium Cone Augments
Cases who receive the Triathlon TS Total Knee System with at least one Triathlon Tritanium Cone Augment
Triathlon Tritanium Cone Augments: The Triathlon Tritanium Cone Augments are an extension of the Triathlon Total Stabilizer (TS) system, intended to be used as an optional accessory component in revision TKA
|
|---|---|
|
Overall Study
Censored (data not included in analysis)
|
64
|
|
Overall Study
Withdrawal by Subject
|
23
|
|
Overall Study
Participant did not complete the Primary Endpoint (2-yr follow-up) visit but continued in study
|
13
|
|
Overall Study
Lost to Follow-up
|
10
|
|
Overall Study
Death
|
5
|
|
Overall Study
Revision/Removal of all implanted cone augments
|
3
|
|
Overall Study
Physician Decision
|
1
|
Baseline Characteristics
Triathlon Tritanium Cone Augments Outcomes Study
Baseline characteristics by cohort
| Measure |
Triathlon Tritanium Cone Augments
n=190 Participants
Cases who receive the Triathlon TS Total Knee System with at least one Triathlon Tritanium Cone Augment
Triathlon Tritanium Cone Augments: The Triathlon Tritanium Cone Augments are an extension of the Triathlon Total Stabilizer (TS) system, intended to be used as an optional accessory component in revision TKA
|
|---|---|
|
Age, Continuous
|
66.67 years
n=24 Participants
|
|
Sex: Female, Male
Female
|
122 Participants
n=24 Participants
|
|
Sex: Female, Male
Male
|
68 Participants
n=24 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
7 Participants
n=24 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
183 Participants
n=24 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=24 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
3 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Black or African American
|
17 Participants
n=24 Participants
|
|
Race (NIH/OMB)
White
|
167 Participants
n=24 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=24 Participants
|
PRIMARY outcome
Timeframe: 2 yearPopulation: 190 participants / 194 cases were evaluated at the 2-year postoperative follow-up timeframe to determine if the femoral and/or tibial cone augment had been revised or removed due to aseptic loosening.
The primary efficacy parameter is the revision/removal of femoral cone augment or tibial cone augment for aseptic loosening at 2 years postoperative. Success at 2 years is defined as no incidence of revision/removal of femoral or tibial cone augment for aseptic loosening within 2 years.
Outcome measures
| Measure |
Revision/Removal of Cone Augment
n=194 cases
The number of revision/removals of tibial and/or femoral cone augment due to aseptic loosening.
|
End of Stem Pain Severity Tibial Only
Patients with only tibial cones completed end of stem pain severity questionnaire.
|
End of Stem Pain Severity Femoral Only
Patients with only femoral cones completed end of stem pain severity questionnaire.
|
Asymmetric Tibial Cone Augment
The Asymmetric Tibial Cone Augment features a lobe at the superior aspect of the cone to fill asymmetric bone voids in the tibial metaphysis.
|
|---|---|---|---|---|
|
Cases With Revision of the Femoral Cone Augment or Tibial Cone Augment for Aseptic Loosening.
|
0 cases
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 2 yearPopulation: 56 (57 cases) out of the 123 (127 cases) participants reported op side pain and answered the End-of-stem pain questionnaire. The number of participants per cones categories are 14 femoral and tibial cones, 41 tibial cones only, and 1 femoral cone only.
End-of-stem pain is determined via a patient questionnaire; 2 questions are asked in regard to shin and thigh pain. Pain for both the shin and thigh are identified using the following categories: * no pain * pain with extreme activity only * pain with moderate activity * pain with normal activity * pain at rest
Outcome measures
| Measure |
Revision/Removal of Cone Augment
n=14 cases
The number of revision/removals of tibial and/or femoral cone augment due to aseptic loosening.
|
End of Stem Pain Severity Tibial Only
n=42 cases
Patients with only tibial cones completed end of stem pain severity questionnaire.
|
End of Stem Pain Severity Femoral Only
n=1 cases
Patients with only femoral cones completed end of stem pain severity questionnaire.
|
Asymmetric Tibial Cone Augment
The Asymmetric Tibial Cone Augment features a lobe at the superior aspect of the cone to fill asymmetric bone voids in the tibial metaphysis.
|
|---|---|---|---|---|
|
Location and Severity of End-of-stem Pain.
Thigh No Pain, Shin No Pain
|
0 cases
|
0 cases
|
0 cases
|
—
|
|
Location and Severity of End-of-stem Pain.
Thigh No Pain, Shin Pain with Extreme Activity Only
|
0 cases
|
3 cases
|
0 cases
|
—
|
|
Location and Severity of End-of-stem Pain.
Thigh No Pain, Shin Pain with Moderate Activity
|
1 cases
|
4 cases
|
1 cases
|
—
|
|
Location and Severity of End-of-stem Pain.
Thigh No Pain, Shin Pain with Normal Activity
|
2 cases
|
3 cases
|
0 cases
|
—
|
|
Location and Severity of End-of-stem Pain.
Thigh No Pain, Shin Pain at Rest
|
0 cases
|
4 cases
|
0 cases
|
—
|
|
Location and Severity of End-of-stem Pain.
Thigh Pain with Extreme Activity Only, Shin No Pain
|
0 cases
|
2 cases
|
0 cases
|
—
|
|
Location and Severity of End-of-stem Pain.
Thigh Pain with Extreme Activity Only , Shin Pain with Extreme Activity Only
|
0 cases
|
1 cases
|
0 cases
|
—
|
|
Location and Severity of End-of-stem Pain.
Thigh Pain with Extreme Activity Only , Shin Pain with Moderate Activity
|
0 cases
|
0 cases
|
0 cases
|
—
|
|
Location and Severity of End-of-stem Pain.
Thigh Pain with Extreme Activity Only , Shin Pain at Rest
|
0 cases
|
0 cases
|
0 cases
|
—
|
|
Location and Severity of End-of-stem Pain.
Thigh Pain with Moderate Activity, Shin No Pain
|
3 cases
|
4 cases
|
0 cases
|
—
|
|
Location and Severity of End-of-stem Pain.
Thigh Pain with Moderate Activity, Shin Pain with Extreme Activity Only
|
0 cases
|
0 cases
|
0 cases
|
—
|
|
Location and Severity of End-of-stem Pain.
Thigh Pain with Moderate Activity, Shin Pain with Moderate Activity
|
4 cases
|
4 cases
|
0 cases
|
—
|
|
Location and Severity of End-of-stem Pain.
Thigh Pain with Moderate Activity, Shin Pain with Normal Activity
|
1 cases
|
4 cases
|
0 cases
|
—
|
|
Location and Severity of End-of-stem Pain.
Thigh Pain with Moderate Activity, Shin Pain at Rest
|
0 cases
|
0 cases
|
0 cases
|
—
|
|
Location and Severity of End-of-stem Pain.
Thigh Pain with Normal Activity, Shin No Pain
|
0 cases
|
2 cases
|
0 cases
|
—
|
|
Location and Severity of End-of-stem Pain.
Thigh Pain with Normal Activity, Shin Pain with Extreme Activity Only
|
0 cases
|
0 cases
|
0 cases
|
—
|
|
Location and Severity of End-of-stem Pain.
Thigh Pain with Normal Activity, Shin Pain with Moderate Activity
|
0 cases
|
2 cases
|
0 cases
|
—
|
|
Location and Severity of End-of-stem Pain.
Thigh Pain with Normal Activity, Shin Pain with Normal Activity
|
2 cases
|
2 cases
|
0 cases
|
—
|
|
Location and Severity of End-of-stem Pain.
Thigh Pain at Rest, Shin Pain with Extreme Activity Only
|
0 cases
|
0 cases
|
0 cases
|
—
|
|
Location and Severity of End-of-stem Pain.
Thigh Pain at Rest, Shin Pain with Moderate Activity
|
0 cases
|
1 cases
|
0 cases
|
—
|
|
Location and Severity of End-of-stem Pain.
Thigh Pain at Rest, Shin Pain with Normal Activity
|
0 cases
|
0 cases
|
0 cases
|
—
|
|
Location and Severity of End-of-stem Pain.
Thigh Pain at Rest, Shin Pain at Rest
|
1 cases
|
1 cases
|
0 cases
|
—
|
|
Location and Severity of End-of-stem Pain.
Thigh Pain with Extreme Activity Only, Shin Pain with Normal Activity
|
0 cases
|
1 cases
|
0 cases
|
—
|
|
Location and Severity of End-of-stem Pain.
Thigh Pain with Normal Activity, Shin Pain at Rest
|
0 cases
|
1 cases
|
0 cases
|
—
|
|
Location and Severity of End-of-stem Pain.
Thigh Pain at Rest, Shin No Pain
|
0 cases
|
3 cases
|
0 cases
|
—
|
SECONDARY outcome
Timeframe: IntraoperativePopulation: The number of cases of cone shape used in participants with AORI bone type classification.
The AORI is a bone defect classification which consists of four Types: Type I: Metaphyseal bone is intact, with minor bone defects not compromising component stability. Type IIA: There is metaphyseal bone damage and cancellous bone loss in one femoral/tibial condyle; cement reinforcement, bone grafting or metal augmentation is needed. Type IIB: There is metaphyseal bone damage and cancellous bone loss in both femoral/tibial condyles; cement reinforcement, bone grafting or metal augmentation is needed. Type III: The metaphyseal bone is deficient and a structural allograft or a custom-made, hinged or revision prosthesis with an extended intramedullary stem is needed.
Outcome measures
| Measure |
Revision/Removal of Cone Augment
n=23 cases
The number of revision/removals of tibial and/or femoral cone augment due to aseptic loosening.
|
End of Stem Pain Severity Tibial Only
n=44 cases
Patients with only tibial cones completed end of stem pain severity questionnaire.
|
End of Stem Pain Severity Femoral Only
n=168 cases
Patients with only femoral cones completed end of stem pain severity questionnaire.
|
Asymmetric Tibial Cone Augment
n=20 cases
The Asymmetric Tibial Cone Augment features a lobe at the superior aspect of the cone to fill asymmetric bone voids in the tibial metaphysis.
|
|---|---|---|---|---|
|
Anderson Orthopaedic Research Institute (AORI) Classification and Cone Augment Shape.
Size 1-2, Femoral AORI Type I
|
0 cases
|
1 cases
|
0 cases
|
0 cases
|
|
Anderson Orthopaedic Research Institute (AORI) Classification and Cone Augment Shape.
Size 1-2, Femoral AORI Type IIa
|
1 cases
|
11 cases
|
0 cases
|
0 cases
|
|
Anderson Orthopaedic Research Institute (AORI) Classification and Cone Augment Shape.
Size 1-2, Femoral AORI Type IIb
|
3 cases
|
18 cases
|
0 cases
|
0 cases
|
|
Anderson Orthopaedic Research Institute (AORI) Classification and Cone Augment Shape.
Size 1-2, Femoral AORI Type III
|
1 cases
|
3 cases
|
0 cases
|
0 cases
|
|
Anderson Orthopaedic Research Institute (AORI) Classification and Cone Augment Shape.
Size 3, Femoral AORI Type IIa
|
0 cases
|
0 cases
|
0 cases
|
0 cases
|
|
Anderson Orthopaedic Research Institute (AORI) Classification and Cone Augment Shape.
Size 3, Femoral AORI Type IIb
|
2 cases
|
0 cases
|
0 cases
|
0 cases
|
|
Anderson Orthopaedic Research Institute (AORI) Classification and Cone Augment Shape.
Size 4, Femoral AORI Type I
|
0 cases
|
0 cases
|
0 cases
|
0 cases
|
|
Anderson Orthopaedic Research Institute (AORI) Classification and Cone Augment Shape.
Size 4, Femoral AORI Type IIa
|
0 cases
|
0 cases
|
0 cases
|
0 cases
|
|
Anderson Orthopaedic Research Institute (AORI) Classification and Cone Augment Shape.
Size 4, Femoral AORI Type IIb
|
5 cases
|
0 cases
|
0 cases
|
0 cases
|
|
Anderson Orthopaedic Research Institute (AORI) Classification and Cone Augment Shape.
Size 4, Femoral AORI Type III
|
0 cases
|
0 cases
|
0 cases
|
0 cases
|
|
Anderson Orthopaedic Research Institute (AORI) Classification and Cone Augment Shape.
Size 3-4, Femoral AORI Type IIa
|
0 cases
|
1 cases
|
0 cases
|
0 cases
|
|
Anderson Orthopaedic Research Institute (AORI) Classification and Cone Augment Shape.
Size 5, Femoral AORI Type IIa
|
0 cases
|
2 cases
|
0 cases
|
0 cases
|
|
Anderson Orthopaedic Research Institute (AORI) Classification and Cone Augment Shape.
Size 5, Femoral AORI Type IIb
|
3 cases
|
1 cases
|
0 cases
|
0 cases
|
|
Anderson Orthopaedic Research Institute (AORI) Classification and Cone Augment Shape.
Size 5, Femoral AORI Type III
|
2 cases
|
0 cases
|
0 cases
|
0 cases
|
|
Anderson Orthopaedic Research Institute (AORI) Classification and Cone Augment Shape.
Size 6, Femoral AORI Type I
|
0 cases
|
0 cases
|
0 cases
|
0 cases
|
|
Anderson Orthopaedic Research Institute (AORI) Classification and Cone Augment Shape.
Size 6, Femoral AORI Type IIb
|
1 cases
|
0 cases
|
0 cases
|
0 cases
|
|
Anderson Orthopaedic Research Institute (AORI) Classification and Cone Augment Shape.
Size 6, Femoral AORI Type III
|
3 cases
|
0 cases
|
0 cases
|
0 cases
|
|
Anderson Orthopaedic Research Institute (AORI) Classification and Cone Augment Shape.
Size 7-8, Femoral AORI Type IIa
|
0 cases
|
1 cases
|
0 cases
|
0 cases
|
|
Anderson Orthopaedic Research Institute (AORI) Classification and Cone Augment Shape.
Size 7-8, Femoral AORI Type IIb
|
1 cases
|
0 cases
|
0 cases
|
0 cases
|
|
Anderson Orthopaedic Research Institute (AORI) Classification and Cone Augment Shape.
Size 7-8, Femoral AORI Type III
|
0 cases
|
0 cases
|
0 cases
|
0 cases
|
|
Anderson Orthopaedic Research Institute (AORI) Classification and Cone Augment Shape.
Size A, Tibial AORI Type I
|
0 cases
|
0 cases
|
8 cases
|
0 cases
|
|
Anderson Orthopaedic Research Institute (AORI) Classification and Cone Augment Shape.
Size A, Tibial AORI Type IIa
|
0 cases
|
0 cases
|
42 cases
|
0 cases
|
|
Anderson Orthopaedic Research Institute (AORI) Classification and Cone Augment Shape.
Size A, Tibial AORI Type IIb
|
0 cases
|
0 cases
|
10 cases
|
0 cases
|
|
Anderson Orthopaedic Research Institute (AORI) Classification and Cone Augment Shape.
Size A, Tibial AORI Type III
|
0 cases
|
0 cases
|
2 cases
|
0 cases
|
|
Anderson Orthopaedic Research Institute (AORI) Classification and Cone Augment Shape.
Size B, Tibial AORI Type IIa
|
0 cases
|
0 cases
|
23 cases
|
1 cases
|
|
Anderson Orthopaedic Research Institute (AORI) Classification and Cone Augment Shape.
Size B, Tibial AORI Type IIb
|
0 cases
|
0 cases
|
27 cases
|
10 cases
|
|
Anderson Orthopaedic Research Institute (AORI) Classification and Cone Augment Shape.
Size B, Tibial AORI Type III
|
0 cases
|
0 cases
|
3 cases
|
2 cases
|
|
Anderson Orthopaedic Research Institute (AORI) Classification and Cone Augment Shape.
Size C, Tibial AORI Type I
|
0 cases
|
0 cases
|
7 cases
|
0 cases
|
|
Anderson Orthopaedic Research Institute (AORI) Classification and Cone Augment Shape.
Size C, Tibial AORI Type IIa
|
0 cases
|
0 cases
|
8 cases
|
1 cases
|
|
Anderson Orthopaedic Research Institute (AORI) Classification and Cone Augment Shape.
Size C, Tibial AORI Type IIb
|
0 cases
|
0 cases
|
12 cases
|
2 cases
|
|
Anderson Orthopaedic Research Institute (AORI) Classification and Cone Augment Shape.
Size C, Tibial AORI Type III
|
0 cases
|
0 cases
|
2 cases
|
2 cases
|
|
Anderson Orthopaedic Research Institute (AORI) Classification and Cone Augment Shape.
Size D, Tibial AORI Type I
|
0 cases
|
0 cases
|
3 cases
|
0 cases
|
|
Anderson Orthopaedic Research Institute (AORI) Classification and Cone Augment Shape.
Size D, Tibial AORI Type IIa
|
0 cases
|
0 cases
|
4 cases
|
0 cases
|
|
Anderson Orthopaedic Research Institute (AORI) Classification and Cone Augment Shape.
Size D, Tibial AORI Type IIb
|
0 cases
|
0 cases
|
4 cases
|
0 cases
|
|
Anderson Orthopaedic Research Institute (AORI) Classification and Cone Augment Shape.
Size D, Tibial AORI Type III
|
0 cases
|
0 cases
|
0 cases
|
1 cases
|
|
Anderson Orthopaedic Research Institute (AORI) Classification and Cone Augment Shape.
Size E, Tibial AORI Type IIa
|
0 cases
|
0 cases
|
5 cases
|
0 cases
|
|
Anderson Orthopaedic Research Institute (AORI) Classification and Cone Augment Shape.
Size E, Tibial AORI Type IIb
|
0 cases
|
0 cases
|
2 cases
|
1 cases
|
|
Anderson Orthopaedic Research Institute (AORI) Classification and Cone Augment Shape.
Size 3, Femoral AORI Type I
|
0 cases
|
0 cases
|
0 cases
|
0 cases
|
|
Anderson Orthopaedic Research Institute (AORI) Classification and Cone Augment Shape.
Size 3, Femoral AORI Type III
|
1 cases
|
0 cases
|
0 cases
|
0 cases
|
|
Anderson Orthopaedic Research Institute (AORI) Classification and Cone Augment Shape.
Size 3-4, Femoral AORI Type I
|
0 cases
|
0 cases
|
0 cases
|
0 cases
|
|
Anderson Orthopaedic Research Institute (AORI) Classification and Cone Augment Shape.
Size 3-4, Femoral AORI Type IIb
|
0 cases
|
3 cases
|
0 cases
|
0 cases
|
|
Anderson Orthopaedic Research Institute (AORI) Classification and Cone Augment Shape.
Size 3-4, Femoral AORI Type III
|
0 cases
|
1 cases
|
0 cases
|
0 cases
|
|
Anderson Orthopaedic Research Institute (AORI) Classification and Cone Augment Shape.
Size 5, Femoral AORI Type I
|
0 cases
|
0 cases
|
0 cases
|
0 cases
|
|
Anderson Orthopaedic Research Institute (AORI) Classification and Cone Augment Shape.
Size 6, Femoral AORI Type IIa
|
0 cases
|
2 cases
|
0 cases
|
0 cases
|
|
Anderson Orthopaedic Research Institute (AORI) Classification and Cone Augment Shape.
Size 7-8, Femoral AORI Type I
|
0 cases
|
0 cases
|
0 cases
|
0 cases
|
|
Anderson Orthopaedic Research Institute (AORI) Classification and Cone Augment Shape.
Size B, Tibial AORI Type I
|
0 cases
|
0 cases
|
4 cases
|
0 cases
|
|
Anderson Orthopaedic Research Institute (AORI) Classification and Cone Augment Shape.
Size E, Tibial AORI Type I
|
0 cases
|
0 cases
|
2 cases
|
0 cases
|
|
Anderson Orthopaedic Research Institute (AORI) Classification and Cone Augment Shape.
Size E, Tibial AORI Type III
|
0 cases
|
0 cases
|
0 cases
|
0 cases
|
Adverse Events
Operative Site Events
Serious events: 29 serious events
Other events: 43 other events
Deaths: 0 deaths
Non-Operative Site Events
Serious events: 11 serious events
Other events: 0 other events
Deaths: 11 deaths
Serious adverse events
| Measure |
Operative Site Events
n=194 participants at risk
All adverse events whether serious or not that occurred within the study population of 194 knees. These events were reported by unit/knees because in the case of bilateral participants (when one participant has both knees enrolled in the study), an event can occur in one knee, both knees or the same knee at different times and are counted separately (by knee) for this reason.
|
Non-Operative Site Events
n=190 participants at risk
All serious systemic adverse events that occurred in the study population of 190 participants. Participants were not assessed for non-serious events that were unrelated to the operative site.
|
|---|---|---|
|
Cardiac disorders
Cardiovascular
|
0.00%
0/194 • The adverse event (AE) reporting requirements for this study are as follows: All AEs that meet the definition of serious and occur within the perioperative period (intraoperative to hospital discharge) to 90 days following the date of surgery. All AEs related to the operative site, regardless of seriousness or time of occurrence.
Serious systemic adverse events (excluding elective procedures), and all AEs, whether serious or not, related to the operative site were collected. Data of occurrence, date diagnosed, type of complication and treatment was collected. Industry standard AE and SAE terms were used in the study.
|
2.1%
4/190 • Number of events 4 • The adverse event (AE) reporting requirements for this study are as follows: All AEs that meet the definition of serious and occur within the perioperative period (intraoperative to hospital discharge) to 90 days following the date of surgery. All AEs related to the operative site, regardless of seriousness or time of occurrence.
Serious systemic adverse events (excluding elective procedures), and all AEs, whether serious or not, related to the operative site were collected. Data of occurrence, date diagnosed, type of complication and treatment was collected. Industry standard AE and SAE terms were used in the study.
|
|
Gastrointestinal disorders
Gastrointestinal
|
0.00%
0/194 • The adverse event (AE) reporting requirements for this study are as follows: All AEs that meet the definition of serious and occur within the perioperative period (intraoperative to hospital discharge) to 90 days following the date of surgery. All AEs related to the operative site, regardless of seriousness or time of occurrence.
Serious systemic adverse events (excluding elective procedures), and all AEs, whether serious or not, related to the operative site were collected. Data of occurrence, date diagnosed, type of complication and treatment was collected. Industry standard AE and SAE terms were used in the study.
|
0.53%
1/190 • Number of events 1 • The adverse event (AE) reporting requirements for this study are as follows: All AEs that meet the definition of serious and occur within the perioperative period (intraoperative to hospital discharge) to 90 days following the date of surgery. All AEs related to the operative site, regardless of seriousness or time of occurrence.
Serious systemic adverse events (excluding elective procedures), and all AEs, whether serious or not, related to the operative site were collected. Data of occurrence, date diagnosed, type of complication and treatment was collected. Industry standard AE and SAE terms were used in the study.
|
|
Infections and infestations
Deep Joint Infection
|
3.1%
6/194 • Number of events 6 • The adverse event (AE) reporting requirements for this study are as follows: All AEs that meet the definition of serious and occur within the perioperative period (intraoperative to hospital discharge) to 90 days following the date of surgery. All AEs related to the operative site, regardless of seriousness or time of occurrence.
Serious systemic adverse events (excluding elective procedures), and all AEs, whether serious or not, related to the operative site were collected. Data of occurrence, date diagnosed, type of complication and treatment was collected. Industry standard AE and SAE terms were used in the study.
|
0.00%
0/190 • The adverse event (AE) reporting requirements for this study are as follows: All AEs that meet the definition of serious and occur within the perioperative period (intraoperative to hospital discharge) to 90 days following the date of surgery. All AEs related to the operative site, regardless of seriousness or time of occurrence.
Serious systemic adverse events (excluding elective procedures), and all AEs, whether serious or not, related to the operative site were collected. Data of occurrence, date diagnosed, type of complication and treatment was collected. Industry standard AE and SAE terms were used in the study.
|
|
Infections and infestations
Excessive Knee Pain
|
0.52%
1/194 • Number of events 1 • The adverse event (AE) reporting requirements for this study are as follows: All AEs that meet the definition of serious and occur within the perioperative period (intraoperative to hospital discharge) to 90 days following the date of surgery. All AEs related to the operative site, regardless of seriousness or time of occurrence.
Serious systemic adverse events (excluding elective procedures), and all AEs, whether serious or not, related to the operative site were collected. Data of occurrence, date diagnosed, type of complication and treatment was collected. Industry standard AE and SAE terms were used in the study.
|
0.00%
0/190 • The adverse event (AE) reporting requirements for this study are as follows: All AEs that meet the definition of serious and occur within the perioperative period (intraoperative to hospital discharge) to 90 days following the date of surgery. All AEs related to the operative site, regardless of seriousness or time of occurrence.
Serious systemic adverse events (excluding elective procedures), and all AEs, whether serious or not, related to the operative site were collected. Data of occurrence, date diagnosed, type of complication and treatment was collected. Industry standard AE and SAE terms were used in the study.
|
|
Infections and infestations
Superficial Wound Infection
|
1.0%
2/194 • Number of events 2 • The adverse event (AE) reporting requirements for this study are as follows: All AEs that meet the definition of serious and occur within the perioperative period (intraoperative to hospital discharge) to 90 days following the date of surgery. All AEs related to the operative site, regardless of seriousness or time of occurrence.
Serious systemic adverse events (excluding elective procedures), and all AEs, whether serious or not, related to the operative site were collected. Data of occurrence, date diagnosed, type of complication and treatment was collected. Industry standard AE and SAE terms were used in the study.
|
0.00%
0/190 • The adverse event (AE) reporting requirements for this study are as follows: All AEs that meet the definition of serious and occur within the perioperative period (intraoperative to hospital discharge) to 90 days following the date of surgery. All AEs related to the operative site, regardless of seriousness or time of occurrence.
Serious systemic adverse events (excluding elective procedures), and all AEs, whether serious or not, related to the operative site were collected. Data of occurrence, date diagnosed, type of complication and treatment was collected. Industry standard AE and SAE terms were used in the study.
|
|
Infections and infestations
Wound Related
|
0.52%
1/194 • Number of events 1 • The adverse event (AE) reporting requirements for this study are as follows: All AEs that meet the definition of serious and occur within the perioperative period (intraoperative to hospital discharge) to 90 days following the date of surgery. All AEs related to the operative site, regardless of seriousness or time of occurrence.
Serious systemic adverse events (excluding elective procedures), and all AEs, whether serious or not, related to the operative site were collected. Data of occurrence, date diagnosed, type of complication and treatment was collected. Industry standard AE and SAE terms were used in the study.
|
0.00%
0/190 • The adverse event (AE) reporting requirements for this study are as follows: All AEs that meet the definition of serious and occur within the perioperative period (intraoperative to hospital discharge) to 90 days following the date of surgery. All AEs related to the operative site, regardless of seriousness or time of occurrence.
Serious systemic adverse events (excluding elective procedures), and all AEs, whether serious or not, related to the operative site were collected. Data of occurrence, date diagnosed, type of complication and treatment was collected. Industry standard AE and SAE terms were used in the study.
|
|
Injury, poisoning and procedural complications
Neurosensory
|
0.00%
0/194 • The adverse event (AE) reporting requirements for this study are as follows: All AEs that meet the definition of serious and occur within the perioperative period (intraoperative to hospital discharge) to 90 days following the date of surgery. All AEs related to the operative site, regardless of seriousness or time of occurrence.
Serious systemic adverse events (excluding elective procedures), and all AEs, whether serious or not, related to the operative site were collected. Data of occurrence, date diagnosed, type of complication and treatment was collected. Industry standard AE and SAE terms were used in the study.
|
0.53%
1/190 • Number of events 1 • The adverse event (AE) reporting requirements for this study are as follows: All AEs that meet the definition of serious and occur within the perioperative period (intraoperative to hospital discharge) to 90 days following the date of surgery. All AEs related to the operative site, regardless of seriousness or time of occurrence.
Serious systemic adverse events (excluding elective procedures), and all AEs, whether serious or not, related to the operative site were collected. Data of occurrence, date diagnosed, type of complication and treatment was collected. Industry standard AE and SAE terms were used in the study.
|
|
Blood and lymphatic system disorders
Systemic Other
|
0.00%
0/194 • The adverse event (AE) reporting requirements for this study are as follows: All AEs that meet the definition of serious and occur within the perioperative period (intraoperative to hospital discharge) to 90 days following the date of surgery. All AEs related to the operative site, regardless of seriousness or time of occurrence.
Serious systemic adverse events (excluding elective procedures), and all AEs, whether serious or not, related to the operative site were collected. Data of occurrence, date diagnosed, type of complication and treatment was collected. Industry standard AE and SAE terms were used in the study.
|
1.1%
2/190 • Number of events 2 • The adverse event (AE) reporting requirements for this study are as follows: All AEs that meet the definition of serious and occur within the perioperative period (intraoperative to hospital discharge) to 90 days following the date of surgery. All AEs related to the operative site, regardless of seriousness or time of occurrence.
Serious systemic adverse events (excluding elective procedures), and all AEs, whether serious or not, related to the operative site were collected. Data of occurrence, date diagnosed, type of complication and treatment was collected. Industry standard AE and SAE terms were used in the study.
|
|
Injury, poisoning and procedural complications
Femoral Fracture
|
1.0%
2/194 • Number of events 2 • The adverse event (AE) reporting requirements for this study are as follows: All AEs that meet the definition of serious and occur within the perioperative period (intraoperative to hospital discharge) to 90 days following the date of surgery. All AEs related to the operative site, regardless of seriousness or time of occurrence.
Serious systemic adverse events (excluding elective procedures), and all AEs, whether serious or not, related to the operative site were collected. Data of occurrence, date diagnosed, type of complication and treatment was collected. Industry standard AE and SAE terms were used in the study.
|
0.00%
0/190 • The adverse event (AE) reporting requirements for this study are as follows: All AEs that meet the definition of serious and occur within the perioperative period (intraoperative to hospital discharge) to 90 days following the date of surgery. All AEs related to the operative site, regardless of seriousness or time of occurrence.
Serious systemic adverse events (excluding elective procedures), and all AEs, whether serious or not, related to the operative site were collected. Data of occurrence, date diagnosed, type of complication and treatment was collected. Industry standard AE and SAE terms were used in the study.
|
|
Injury, poisoning and procedural complications
Loosening Patellar Component
|
0.52%
1/194 • Number of events 1 • The adverse event (AE) reporting requirements for this study are as follows: All AEs that meet the definition of serious and occur within the perioperative period (intraoperative to hospital discharge) to 90 days following the date of surgery. All AEs related to the operative site, regardless of seriousness or time of occurrence.
Serious systemic adverse events (excluding elective procedures), and all AEs, whether serious or not, related to the operative site were collected. Data of occurrence, date diagnosed, type of complication and treatment was collected. Industry standard AE and SAE terms were used in the study.
|
0.00%
0/190 • The adverse event (AE) reporting requirements for this study are as follows: All AEs that meet the definition of serious and occur within the perioperative period (intraoperative to hospital discharge) to 90 days following the date of surgery. All AEs related to the operative site, regardless of seriousness or time of occurrence.
Serious systemic adverse events (excluding elective procedures), and all AEs, whether serious or not, related to the operative site were collected. Data of occurrence, date diagnosed, type of complication and treatment was collected. Industry standard AE and SAE terms were used in the study.
|
|
Injury, poisoning and procedural complications
Patellar Component Dislocation
|
0.52%
1/194 • Number of events 1 • The adverse event (AE) reporting requirements for this study are as follows: All AEs that meet the definition of serious and occur within the perioperative period (intraoperative to hospital discharge) to 90 days following the date of surgery. All AEs related to the operative site, regardless of seriousness or time of occurrence.
Serious systemic adverse events (excluding elective procedures), and all AEs, whether serious or not, related to the operative site were collected. Data of occurrence, date diagnosed, type of complication and treatment was collected. Industry standard AE and SAE terms were used in the study.
|
0.00%
0/190 • The adverse event (AE) reporting requirements for this study are as follows: All AEs that meet the definition of serious and occur within the perioperative period (intraoperative to hospital discharge) to 90 days following the date of surgery. All AEs related to the operative site, regardless of seriousness or time of occurrence.
Serious systemic adverse events (excluding elective procedures), and all AEs, whether serious or not, related to the operative site were collected. Data of occurrence, date diagnosed, type of complication and treatment was collected. Industry standard AE and SAE terms were used in the study.
|
|
Injury, poisoning and procedural complications
Patellar Tendon Rupture
|
0.52%
1/194 • Number of events 1 • The adverse event (AE) reporting requirements for this study are as follows: All AEs that meet the definition of serious and occur within the perioperative period (intraoperative to hospital discharge) to 90 days following the date of surgery. All AEs related to the operative site, regardless of seriousness or time of occurrence.
Serious systemic adverse events (excluding elective procedures), and all AEs, whether serious or not, related to the operative site were collected. Data of occurrence, date diagnosed, type of complication and treatment was collected. Industry standard AE and SAE terms were used in the study.
|
0.00%
0/190 • The adverse event (AE) reporting requirements for this study are as follows: All AEs that meet the definition of serious and occur within the perioperative period (intraoperative to hospital discharge) to 90 days following the date of surgery. All AEs related to the operative site, regardless of seriousness or time of occurrence.
Serious systemic adverse events (excluding elective procedures), and all AEs, whether serious or not, related to the operative site were collected. Data of occurrence, date diagnosed, type of complication and treatment was collected. Industry standard AE and SAE terms were used in the study.
|
|
Injury, poisoning and procedural complications
Wound Related
|
0.52%
1/194 • Number of events 1 • The adverse event (AE) reporting requirements for this study are as follows: All AEs that meet the definition of serious and occur within the perioperative period (intraoperative to hospital discharge) to 90 days following the date of surgery. All AEs related to the operative site, regardless of seriousness or time of occurrence.
Serious systemic adverse events (excluding elective procedures), and all AEs, whether serious or not, related to the operative site were collected. Data of occurrence, date diagnosed, type of complication and treatment was collected. Industry standard AE and SAE terms were used in the study.
|
0.00%
0/190 • The adverse event (AE) reporting requirements for this study are as follows: All AEs that meet the definition of serious and occur within the perioperative period (intraoperative to hospital discharge) to 90 days following the date of surgery. All AEs related to the operative site, regardless of seriousness or time of occurrence.
Serious systemic adverse events (excluding elective procedures), and all AEs, whether serious or not, related to the operative site were collected. Data of occurrence, date diagnosed, type of complication and treatment was collected. Industry standard AE and SAE terms were used in the study.
|
|
Musculoskeletal and connective tissue disorders
Arthrofibrosis
|
5.2%
10/194 • Number of events 10 • The adverse event (AE) reporting requirements for this study are as follows: All AEs that meet the definition of serious and occur within the perioperative period (intraoperative to hospital discharge) to 90 days following the date of surgery. All AEs related to the operative site, regardless of seriousness or time of occurrence.
Serious systemic adverse events (excluding elective procedures), and all AEs, whether serious or not, related to the operative site were collected. Data of occurrence, date diagnosed, type of complication and treatment was collected. Industry standard AE and SAE terms were used in the study.
|
0.00%
0/190 • The adverse event (AE) reporting requirements for this study are as follows: All AEs that meet the definition of serious and occur within the perioperative period (intraoperative to hospital discharge) to 90 days following the date of surgery. All AEs related to the operative site, regardless of seriousness or time of occurrence.
Serious systemic adverse events (excluding elective procedures), and all AEs, whether serious or not, related to the operative site were collected. Data of occurrence, date diagnosed, type of complication and treatment was collected. Industry standard AE and SAE terms were used in the study.
|
|
Musculoskeletal and connective tissue disorders
Excessive Knee Pain
|
1.0%
2/194 • Number of events 2 • The adverse event (AE) reporting requirements for this study are as follows: All AEs that meet the definition of serious and occur within the perioperative period (intraoperative to hospital discharge) to 90 days following the date of surgery. All AEs related to the operative site, regardless of seriousness or time of occurrence.
Serious systemic adverse events (excluding elective procedures), and all AEs, whether serious or not, related to the operative site were collected. Data of occurrence, date diagnosed, type of complication and treatment was collected. Industry standard AE and SAE terms were used in the study.
|
0.00%
0/190 • The adverse event (AE) reporting requirements for this study are as follows: All AEs that meet the definition of serious and occur within the perioperative period (intraoperative to hospital discharge) to 90 days following the date of surgery. All AEs related to the operative site, regardless of seriousness or time of occurrence.
Serious systemic adverse events (excluding elective procedures), and all AEs, whether serious or not, related to the operative site were collected. Data of occurrence, date diagnosed, type of complication and treatment was collected. Industry standard AE and SAE terms were used in the study.
|
|
Musculoskeletal and connective tissue disorders
Loosening Femoral Component
|
0.52%
1/194 • Number of events 1 • The adverse event (AE) reporting requirements for this study are as follows: All AEs that meet the definition of serious and occur within the perioperative period (intraoperative to hospital discharge) to 90 days following the date of surgery. All AEs related to the operative site, regardless of seriousness or time of occurrence.
Serious systemic adverse events (excluding elective procedures), and all AEs, whether serious or not, related to the operative site were collected. Data of occurrence, date diagnosed, type of complication and treatment was collected. Industry standard AE and SAE terms were used in the study.
|
0.00%
0/190 • The adverse event (AE) reporting requirements for this study are as follows: All AEs that meet the definition of serious and occur within the perioperative period (intraoperative to hospital discharge) to 90 days following the date of surgery. All AEs related to the operative site, regardless of seriousness or time of occurrence.
Serious systemic adverse events (excluding elective procedures), and all AEs, whether serious or not, related to the operative site were collected. Data of occurrence, date diagnosed, type of complication and treatment was collected. Industry standard AE and SAE terms were used in the study.
|
|
Musculoskeletal and connective tissue disorders
Loosening Tibial Component
|
0.52%
1/194 • Number of events 1 • The adverse event (AE) reporting requirements for this study are as follows: All AEs that meet the definition of serious and occur within the perioperative period (intraoperative to hospital discharge) to 90 days following the date of surgery. All AEs related to the operative site, regardless of seriousness or time of occurrence.
Serious systemic adverse events (excluding elective procedures), and all AEs, whether serious or not, related to the operative site were collected. Data of occurrence, date diagnosed, type of complication and treatment was collected. Industry standard AE and SAE terms were used in the study.
|
0.00%
0/190 • The adverse event (AE) reporting requirements for this study are as follows: All AEs that meet the definition of serious and occur within the perioperative period (intraoperative to hospital discharge) to 90 days following the date of surgery. All AEs related to the operative site, regardless of seriousness or time of occurrence.
Serious systemic adverse events (excluding elective procedures), and all AEs, whether serious or not, related to the operative site were collected. Data of occurrence, date diagnosed, type of complication and treatment was collected. Industry standard AE and SAE terms were used in the study.
|
|
Musculoskeletal and connective tissue disorders
Operative Site Other
|
0.52%
1/194 • Number of events 1 • The adverse event (AE) reporting requirements for this study are as follows: All AEs that meet the definition of serious and occur within the perioperative period (intraoperative to hospital discharge) to 90 days following the date of surgery. All AEs related to the operative site, regardless of seriousness or time of occurrence.
Serious systemic adverse events (excluding elective procedures), and all AEs, whether serious or not, related to the operative site were collected. Data of occurrence, date diagnosed, type of complication and treatment was collected. Industry standard AE and SAE terms were used in the study.
|
0.00%
0/190 • The adverse event (AE) reporting requirements for this study are as follows: All AEs that meet the definition of serious and occur within the perioperative period (intraoperative to hospital discharge) to 90 days following the date of surgery. All AEs related to the operative site, regardless of seriousness or time of occurrence.
Serious systemic adverse events (excluding elective procedures), and all AEs, whether serious or not, related to the operative site were collected. Data of occurrence, date diagnosed, type of complication and treatment was collected. Industry standard AE and SAE terms were used in the study.
|
|
Musculoskeletal and connective tissue disorders
Patellar Subluxation
|
1.0%
2/194 • Number of events 2 • The adverse event (AE) reporting requirements for this study are as follows: All AEs that meet the definition of serious and occur within the perioperative period (intraoperative to hospital discharge) to 90 days following the date of surgery. All AEs related to the operative site, regardless of seriousness or time of occurrence.
Serious systemic adverse events (excluding elective procedures), and all AEs, whether serious or not, related to the operative site were collected. Data of occurrence, date diagnosed, type of complication and treatment was collected. Industry standard AE and SAE terms were used in the study.
|
0.00%
0/190 • The adverse event (AE) reporting requirements for this study are as follows: All AEs that meet the definition of serious and occur within the perioperative period (intraoperative to hospital discharge) to 90 days following the date of surgery. All AEs related to the operative site, regardless of seriousness or time of occurrence.
Serious systemic adverse events (excluding elective procedures), and all AEs, whether serious or not, related to the operative site were collected. Data of occurrence, date diagnosed, type of complication and treatment was collected. Industry standard AE and SAE terms were used in the study.
|
|
Musculoskeletal and connective tissue disorders
Wound Related
|
0.52%
1/194 • Number of events 1 • The adverse event (AE) reporting requirements for this study are as follows: All AEs that meet the definition of serious and occur within the perioperative period (intraoperative to hospital discharge) to 90 days following the date of surgery. All AEs related to the operative site, regardless of seriousness or time of occurrence.
Serious systemic adverse events (excluding elective procedures), and all AEs, whether serious or not, related to the operative site were collected. Data of occurrence, date diagnosed, type of complication and treatment was collected. Industry standard AE and SAE terms were used in the study.
|
0.00%
0/190 • The adverse event (AE) reporting requirements for this study are as follows: All AEs that meet the definition of serious and occur within the perioperative period (intraoperative to hospital discharge) to 90 days following the date of surgery. All AEs related to the operative site, regardless of seriousness or time of occurrence.
Serious systemic adverse events (excluding elective procedures), and all AEs, whether serious or not, related to the operative site were collected. Data of occurrence, date diagnosed, type of complication and treatment was collected. Industry standard AE and SAE terms were used in the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Systemic Other
|
0.00%
0/194 • The adverse event (AE) reporting requirements for this study are as follows: All AEs that meet the definition of serious and occur within the perioperative period (intraoperative to hospital discharge) to 90 days following the date of surgery. All AEs related to the operative site, regardless of seriousness or time of occurrence.
Serious systemic adverse events (excluding elective procedures), and all AEs, whether serious or not, related to the operative site were collected. Data of occurrence, date diagnosed, type of complication and treatment was collected. Industry standard AE and SAE terms were used in the study.
|
0.53%
1/190 • Number of events 1 • The adverse event (AE) reporting requirements for this study are as follows: All AEs that meet the definition of serious and occur within the perioperative period (intraoperative to hospital discharge) to 90 days following the date of surgery. All AEs related to the operative site, regardless of seriousness or time of occurrence.
Serious systemic adverse events (excluding elective procedures), and all AEs, whether serious or not, related to the operative site were collected. Data of occurrence, date diagnosed, type of complication and treatment was collected. Industry standard AE and SAE terms were used in the study.
|
|
Nervous system disorders
Neurosensory
|
0.00%
0/194 • The adverse event (AE) reporting requirements for this study are as follows: All AEs that meet the definition of serious and occur within the perioperative period (intraoperative to hospital discharge) to 90 days following the date of surgery. All AEs related to the operative site, regardless of seriousness or time of occurrence.
Serious systemic adverse events (excluding elective procedures), and all AEs, whether serious or not, related to the operative site were collected. Data of occurrence, date diagnosed, type of complication and treatment was collected. Industry standard AE and SAE terms were used in the study.
|
0.53%
1/190 • Number of events 1 • The adverse event (AE) reporting requirements for this study are as follows: All AEs that meet the definition of serious and occur within the perioperative period (intraoperative to hospital discharge) to 90 days following the date of surgery. All AEs related to the operative site, regardless of seriousness or time of occurrence.
Serious systemic adverse events (excluding elective procedures), and all AEs, whether serious or not, related to the operative site were collected. Data of occurrence, date diagnosed, type of complication and treatment was collected. Industry standard AE and SAE terms were used in the study.
|
|
Renal and urinary disorders
Genitourinary
|
0.00%
0/194 • The adverse event (AE) reporting requirements for this study are as follows: All AEs that meet the definition of serious and occur within the perioperative period (intraoperative to hospital discharge) to 90 days following the date of surgery. All AEs related to the operative site, regardless of seriousness or time of occurrence.
Serious systemic adverse events (excluding elective procedures), and all AEs, whether serious or not, related to the operative site were collected. Data of occurrence, date diagnosed, type of complication and treatment was collected. Industry standard AE and SAE terms were used in the study.
|
0.53%
1/190 • Number of events 2 • The adverse event (AE) reporting requirements for this study are as follows: All AEs that meet the definition of serious and occur within the perioperative period (intraoperative to hospital discharge) to 90 days following the date of surgery. All AEs related to the operative site, regardless of seriousness or time of occurrence.
Serious systemic adverse events (excluding elective procedures), and all AEs, whether serious or not, related to the operative site were collected. Data of occurrence, date diagnosed, type of complication and treatment was collected. Industry standard AE and SAE terms were used in the study.
|
|
Renal and urinary disorders
Systemic Other
|
0.00%
0/194 • The adverse event (AE) reporting requirements for this study are as follows: All AEs that meet the definition of serious and occur within the perioperative period (intraoperative to hospital discharge) to 90 days following the date of surgery. All AEs related to the operative site, regardless of seriousness or time of occurrence.
Serious systemic adverse events (excluding elective procedures), and all AEs, whether serious or not, related to the operative site were collected. Data of occurrence, date diagnosed, type of complication and treatment was collected. Industry standard AE and SAE terms were used in the study.
|
0.53%
1/190 • Number of events 1 • The adverse event (AE) reporting requirements for this study are as follows: All AEs that meet the definition of serious and occur within the perioperative period (intraoperative to hospital discharge) to 90 days following the date of surgery. All AEs related to the operative site, regardless of seriousness or time of occurrence.
Serious systemic adverse events (excluding elective procedures), and all AEs, whether serious or not, related to the operative site were collected. Data of occurrence, date diagnosed, type of complication and treatment was collected. Industry standard AE and SAE terms were used in the study.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchopulmonary
|
0.00%
0/194 • The adverse event (AE) reporting requirements for this study are as follows: All AEs that meet the definition of serious and occur within the perioperative period (intraoperative to hospital discharge) to 90 days following the date of surgery. All AEs related to the operative site, regardless of seriousness or time of occurrence.
Serious systemic adverse events (excluding elective procedures), and all AEs, whether serious or not, related to the operative site were collected. Data of occurrence, date diagnosed, type of complication and treatment was collected. Industry standard AE and SAE terms were used in the study.
|
0.53%
1/190 • Number of events 1 • The adverse event (AE) reporting requirements for this study are as follows: All AEs that meet the definition of serious and occur within the perioperative period (intraoperative to hospital discharge) to 90 days following the date of surgery. All AEs related to the operative site, regardless of seriousness or time of occurrence.
Serious systemic adverse events (excluding elective procedures), and all AEs, whether serious or not, related to the operative site were collected. Data of occurrence, date diagnosed, type of complication and treatment was collected. Industry standard AE and SAE terms were used in the study.
|
|
Vascular disorders
Cardiovascular
|
0.00%
0/194 • The adverse event (AE) reporting requirements for this study are as follows: All AEs that meet the definition of serious and occur within the perioperative period (intraoperative to hospital discharge) to 90 days following the date of surgery. All AEs related to the operative site, regardless of seriousness or time of occurrence.
Serious systemic adverse events (excluding elective procedures), and all AEs, whether serious or not, related to the operative site were collected. Data of occurrence, date diagnosed, type of complication and treatment was collected. Industry standard AE and SAE terms were used in the study.
|
0.53%
1/190 • Number of events 1 • The adverse event (AE) reporting requirements for this study are as follows: All AEs that meet the definition of serious and occur within the perioperative period (intraoperative to hospital discharge) to 90 days following the date of surgery. All AEs related to the operative site, regardless of seriousness or time of occurrence.
Serious systemic adverse events (excluding elective procedures), and all AEs, whether serious or not, related to the operative site were collected. Data of occurrence, date diagnosed, type of complication and treatment was collected. Industry standard AE and SAE terms were used in the study.
|
Other adverse events
| Measure |
Operative Site Events
n=194 participants at risk
All adverse events whether serious or not that occurred within the study population of 194 knees. These events were reported by unit/knees because in the case of bilateral participants (when one participant has both knees enrolled in the study), an event can occur in one knee, both knees or the same knee at different times and are counted separately (by knee) for this reason.
|
Non-Operative Site Events
n=190 participants at risk
All serious systemic adverse events that occurred in the study population of 190 participants. Participants were not assessed for non-serious events that were unrelated to the operative site.
|
|---|---|---|
|
Injury, poisoning and procedural complications
Soft Tissue Trauma
|
6.7%
13/194 • Number of events 14 • The adverse event (AE) reporting requirements for this study are as follows: All AEs that meet the definition of serious and occur within the perioperative period (intraoperative to hospital discharge) to 90 days following the date of surgery. All AEs related to the operative site, regardless of seriousness or time of occurrence.
Serious systemic adverse events (excluding elective procedures), and all AEs, whether serious or not, related to the operative site were collected. Data of occurrence, date diagnosed, type of complication and treatment was collected. Industry standard AE and SAE terms were used in the study.
|
—
0/0 • The adverse event (AE) reporting requirements for this study are as follows: All AEs that meet the definition of serious and occur within the perioperative period (intraoperative to hospital discharge) to 90 days following the date of surgery. All AEs related to the operative site, regardless of seriousness or time of occurrence.
Serious systemic adverse events (excluding elective procedures), and all AEs, whether serious or not, related to the operative site were collected. Data of occurrence, date diagnosed, type of complication and treatment was collected. Industry standard AE and SAE terms were used in the study.
|
|
Musculoskeletal and connective tissue disorders
Excessive Knee Pain
|
15.5%
30/194 • Number of events 30 • The adverse event (AE) reporting requirements for this study are as follows: All AEs that meet the definition of serious and occur within the perioperative period (intraoperative to hospital discharge) to 90 days following the date of surgery. All AEs related to the operative site, regardless of seriousness or time of occurrence.
Serious systemic adverse events (excluding elective procedures), and all AEs, whether serious or not, related to the operative site were collected. Data of occurrence, date diagnosed, type of complication and treatment was collected. Industry standard AE and SAE terms were used in the study.
|
—
0/0 • The adverse event (AE) reporting requirements for this study are as follows: All AEs that meet the definition of serious and occur within the perioperative period (intraoperative to hospital discharge) to 90 days following the date of surgery. All AEs related to the operative site, regardless of seriousness or time of occurrence.
Serious systemic adverse events (excluding elective procedures), and all AEs, whether serious or not, related to the operative site were collected. Data of occurrence, date diagnosed, type of complication and treatment was collected. Industry standard AE and SAE terms were used in the study.
|
Additional Information
Alexandra Valentino, Manager Clinical Research
Stryker
Phone: +1 908 868 9086
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Each study investigator has independent publication privileges for their own center's results after multi-center publications are submitted. Sponsor requires review of publications. Sponsor shall not edit or influence the publications except to ensure that confidential information is not disclosed, no off-label device use is promoted, and that data is accurately represented. Any publications must be submitted to Stryker for review at least 60 days prior to submission of publication.
- Publication restrictions are in place
Restriction type: OTHER