Trial Outcomes & Findings for Triathlon Tritanium Knee Outcomes Study (NCT NCT02155712)
NCT ID: NCT02155712
Last Updated: 2023-11-14
Results Overview
Success is defined as freedom from Triathlon Tritanium Tibial Baseplate revision for aseptic loosening.
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
680 participants
Primary outcome timeframe
2 years
Results posted on
2023-11-14
Participant Flow
Cohort 1: 397 participants/451 knees - 78 cases censored leaving 319 participants/373 knees. Cohort 2: 216 participants/229 knees - 82 cases censored leaving 134 participants/147 knees.
Participant milestones
| Measure |
Cohort 1 Cementless
Cases are enrolled in the Cohort 1 (cementless) until a total of 356 cases receive the Triathlon Tritanium Tibial Baseplate, Triathlon Tritanium Patella, Triathlon CR or PS Beaded Femur with PA and the Triathlon Tibial Insert. All components in this cohort must used in a cementless application.
It should be noted that Cohort 1 over-enrolled by 17 cases for a total of 373 cases.
|
Cohort 2 Cemented
Enrollment in Cohort 2 (cemented) will begin upon completion of enrollment into the Cohort 1 (cementless), and will continue until a total of 144 cases receive the Triathlon Tibial Tray, Triathlon Patella, Triathlon CR or PS Femur and Triathlon Tibial Insert. All components in this cohort must be used in a cemented application.
|
|---|---|---|
|
Overall Study
STARTED
|
397
|
216
|
|
Overall Study
COMPLETED
|
0
|
37
|
|
Overall Study
NOT COMPLETED
|
397
|
179
|
Reasons for withdrawal
| Measure |
Cohort 1 Cementless
Cases are enrolled in the Cohort 1 (cementless) until a total of 356 cases receive the Triathlon Tritanium Tibial Baseplate, Triathlon Tritanium Patella, Triathlon CR or PS Beaded Femur with PA and the Triathlon Tibial Insert. All components in this cohort must used in a cementless application.
It should be noted that Cohort 1 over-enrolled by 17 cases for a total of 373 cases.
|
Cohort 2 Cemented
Enrollment in Cohort 2 (cemented) will begin upon completion of enrollment into the Cohort 1 (cementless), and will continue until a total of 144 cases receive the Triathlon Tibial Tray, Triathlon Patella, Triathlon CR or PS Femur and Triathlon Tibial Insert. All components in this cohort must be used in a cemented application.
|
|---|---|---|
|
Overall Study
Death
|
12
|
0
|
|
Overall Study
Lost to Follow-up
|
37
|
22
|
|
Overall Study
Revision of device
|
4
|
3
|
|
Overall Study
Withdrawal by Subject
|
39
|
21
|
|
Overall Study
Site termination
|
77
|
19
|
|
Overall Study
Sponsor terminated study early
|
150
|
0
|
|
Overall Study
Missed final 5-year protocol visit
|
0
|
32
|
|
Overall Study
Censored because surgery cancelled
|
6
|
10
|
|
Overall Study
Censored because study device was not implanted
|
61
|
66
|
|
Overall Study
Censored because of inclusion/exclusion violation
|
11
|
6
|
Baseline Characteristics
Triathlon Tritanium Knee Outcomes Study
Baseline characteristics by cohort
| Measure |
Cohort 1 Cementless
n=373 Knees
Cases are enrolled in the Cohort 1 (cementless) until a total of 356 cases receive the Triathlon Tritanium Tibial Baseplate, Triathlon Tritanium Patella, Triathlon CR or PS Beaded Femur with PA and the Triathlon Tibial Insert. All components in this cohort must used in a cementless application.
Triathlon Tritanium Knee: Cementless
|
Cohort 2 Cemented
n=147 Knees
Enrollment in Cohort 2 (cemented) will begin upon completion of enrollment into the Cohort 1 (cementless), and will continue until a total of 144 cases receive the Triathlon Tibial Tray, Triathlon Patella, Triathlon CR or PS Femur and Triathlon Tibial Insert. All components in this cohort must be used in a cemented application.
Triathlon Knee: Cemented
|
Total
n=520 Knees
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
62.12 years
STANDARD_DEVIATION 7.19 • n=5 Participants
|
63.18 years
STANDARD_DEVIATION 7.71 • n=7 Participants
|
62.42 years
STANDARD_DEVIATION 7.34 • n=5 Participants
|
|
Sex: Female, Male
Female
|
155 Participants
n=5 Participants
|
57 Participants
n=7 Participants
|
212 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
164 Participants
n=5 Participants
|
77 Participants
n=7 Participants
|
241 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
8 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
299 Participants
n=5 Participants
|
127 Participants
n=7 Participants
|
426 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
12 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
319 participants
n=5 Participants
|
134 participants
n=7 Participants
|
453 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 2 yearsPopulation: The primary objective analysis only includes cementless, Cohort 1 participants. All Cohort 2 participants received cemented primary total knee replacements and are not included in the primary objective analysis.
Success is defined as freedom from Triathlon Tritanium Tibial Baseplate revision for aseptic loosening.
Outcome measures
| Measure |
Cohort 1 Cementless
n=373 Knees
Cases are enrolled in the Cohort 1 (cementless) until a total of 356 cases receive the Triathlon Tritanium Tibial Baseplate, Triathlon Tritanium Patella, Triathlon CR or PS Beaded Femur with PA and the Triathlon Tibial Insert. All components in this cohort must used in a cementless application.
|
Cohort 2 Cemented
Enrollment in Cohort 2 (cemented) will begin upon completion of enrollment into the Cohort 1 (cementless), and will continue until a total of 144 cases receive the Triathlon Tibial Tray, Triathlon Patella, Triathlon CR or PS Femur and Triathlon Tibial Insert. All components in this cohort must be used in a cemented application.
|
|---|---|---|
|
Number of Knees With Cementless Application That Had Successful Primary Total Knee Replacement With the Triathlon Tritanium Total Knee System
|
373 Successful Knees
|
—
|
SECONDARY outcome
Timeframe: 10 yearsPopulation: Results below are for the participants/knees that were measured and analyzed at 1-year, 3-year, 5-year, 7-year postoperative on Cohort 1 cementless only as per protocol. The final 10 year was not analyzed due to early study termination.
This secondary outcome measure is a statistical estimation on the number of cases at risk at 1-year, 3-years, 5-years and 7-years postoperative in the cementless cohort 1 only, per protocol. The final 10-year results were not done due to early study termination.
Outcome measures
| Measure |
Cohort 1 Cementless
n=373 Knees
Cases are enrolled in the Cohort 1 (cementless) until a total of 356 cases receive the Triathlon Tritanium Tibial Baseplate, Triathlon Tritanium Patella, Triathlon CR or PS Beaded Femur with PA and the Triathlon Tibial Insert. All components in this cohort must used in a cementless application.
|
Cohort 2 Cemented
Enrollment in Cohort 2 (cemented) will begin upon completion of enrollment into the Cohort 1 (cementless), and will continue until a total of 144 cases receive the Triathlon Tibial Tray, Triathlon Patella, Triathlon CR or PS Femur and Triathlon Tibial Insert. All components in this cohort must be used in a cemented application.
|
|---|---|---|
|
Implant Survivorship (Baseplate and Patella)
1-year KM survival rate
|
99.42 percentage of cementless knees
Interval 97.71 to 99.86
|
—
|
|
Implant Survivorship (Baseplate and Patella)
3-year KM survival rate
|
98.74 percentage of cementless knees
Interval 96.67 to 99.53
|
—
|
|
Implant Survivorship (Baseplate and Patella)
5-year KM survival rate
|
98.74 percentage of cementless knees
Interval 96.67 to 99.53
|
—
|
|
Implant Survivorship (Baseplate and Patella)
7-year KM survival rate
|
98.05 percentage of cementless knees
Interval 95.06 to 99.24
|
—
|
SECONDARY outcome
Timeframe: 2 yearsPopulation: Participants with available data at 2 years are presented for both cohorts.
The 2011 Knee Society Score System is comprised of 4 distinct sub-scores: Objective, Functional, Patient Satisfaction and Expectations. The Objective and Functional sub-scores range from a potential minimum score of 0 to a maximum score of 100 points. The Patient Satisfaction sub-score ranges from a potential minimum score of 0 to a maximum score of 40 points. The Subject Expectations sub-score ranges from a potential minimum score of 0 to a maximum score of 15 points. Although the specific scores are not distinguished as "excellent," "good," "fair," or "poor," a higher value represents a better outcome.
Outcome measures
| Measure |
Cohort 1 Cementless
n=289 Knees
Cases are enrolled in the Cohort 1 (cementless) until a total of 356 cases receive the Triathlon Tritanium Tibial Baseplate, Triathlon Tritanium Patella, Triathlon CR or PS Beaded Femur with PA and the Triathlon Tibial Insert. All components in this cohort must used in a cementless application.
|
Cohort 2 Cemented
n=100 Knees
Enrollment in Cohort 2 (cemented) will begin upon completion of enrollment into the Cohort 1 (cementless), and will continue until a total of 144 cases receive the Triathlon Tibial Tray, Triathlon Patella, Triathlon CR or PS Femur and Triathlon Tibial Insert. All components in this cohort must be used in a cemented application.
|
|---|---|---|
|
Compare 2011 Knee Society Score (KSS) Scores Between Both Groups
Objective Knee Score
|
94.90 units on a scale
Standard Deviation 6.48
|
91.75 units on a scale
Standard Deviation 9.40
|
|
Compare 2011 Knee Society Score (KSS) Scores Between Both Groups
Function Score KSS
|
80.85 units on a scale
Standard Deviation 15.56
|
75.41 units on a scale
Standard Deviation 18.81
|
|
Compare 2011 Knee Society Score (KSS) Scores Between Both Groups
Patient Satisfaction Score
|
35.29 units on a scale
Standard Deviation 6.76
|
33.08 units on a scale
Standard Deviation 8.06
|
|
Compare 2011 Knee Society Score (KSS) Scores Between Both Groups
Patient Expectation Score
|
10.60 units on a scale
Standard Deviation 3.04
|
10.06 units on a scale
Standard Deviation 2.89
|
SECONDARY outcome
Timeframe: 2 yearsPopulation: Participants with available data at 2 years are presented for both cohorts.
The OKS questionnaire consists of 12 questions that cover function and pain of the knee. Each question is scored from 0 to 4 (0 being the worst outcome and 4 being the best). The overall score is the sum of all items and can range from 0 to 48, with higher scores corresponding to better outcomes.
Outcome measures
| Measure |
Cohort 1 Cementless
n=291 Knees
Cases are enrolled in the Cohort 1 (cementless) until a total of 356 cases receive the Triathlon Tritanium Tibial Baseplate, Triathlon Tritanium Patella, Triathlon CR or PS Beaded Femur with PA and the Triathlon Tibial Insert. All components in this cohort must used in a cementless application.
|
Cohort 2 Cemented
n=100 Knees
Enrollment in Cohort 2 (cemented) will begin upon completion of enrollment into the Cohort 1 (cementless), and will continue until a total of 144 cases receive the Triathlon Tibial Tray, Triathlon Patella, Triathlon CR or PS Femur and Triathlon Tibial Insert. All components in this cohort must be used in a cemented application.
|
|---|---|---|
|
Compare Oxford Knee Score (OKS) Scores Between Both Groups
|
42.59 units on a scale
Standard Deviation 5.91
|
40.66 units on a scale
Standard Deviation 7.79
|
SECONDARY outcome
Timeframe: 2 yearsPopulation: Participants with available data at 2 years are presented for both cohorts.
The SF-12 Health Survey is a 12-item patient quality-of-life questionnaire to measure general health and well-being. It is comprised of two distinct scores (physical and mental component score). They are both calculated on a scale ranging from 0 points to 100 points, with low values representing a poor health state and high values representing a good health state.
Outcome measures
| Measure |
Cohort 1 Cementless
n=285 Knees
Cases are enrolled in the Cohort 1 (cementless) until a total of 356 cases receive the Triathlon Tritanium Tibial Baseplate, Triathlon Tritanium Patella, Triathlon CR or PS Beaded Femur with PA and the Triathlon Tibial Insert. All components in this cohort must used in a cementless application.
|
Cohort 2 Cemented
n=100 Knees
Enrollment in Cohort 2 (cemented) will begin upon completion of enrollment into the Cohort 1 (cementless), and will continue until a total of 144 cases receive the Triathlon Tibial Tray, Triathlon Patella, Triathlon CR or PS Femur and Triathlon Tibial Insert. All components in this cohort must be used in a cemented application.
|
|---|---|---|
|
Compare Short Form-12 (SF-12) Scores Between Both Groups
SF-12 Physical Component Score
|
49.07 units on a scale
Standard Deviation 8.36
|
46.24 units on a scale
Standard Deviation 9.37
|
|
Compare Short Form-12 (SF-12) Scores Between Both Groups
SF-12 Mental Component Score
|
56.10 units on a scale
Standard Deviation 7.46
|
54.28 units on a scale
Standard Deviation 8.64
|
Adverse Events
Cohort 1 Cementless
Serious events: 28 serious events
Other events: 69 other events
Deaths: 12 deaths
Cohort 2 Cemented
Serious events: 8 serious events
Other events: 12 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cohort 1 Cementless
n=319 participants at risk
Cases are enrolled in the Cohort 1 (cementless) until a total of 356 cases receive the Triathlon Tritanium Tibial Baseplate, Triathlon Tritanium Patella, Triathlon CR or PS Beaded Femur with PA and the Triathlon Tibial Insert. All components in this cohort must used in a cementless application.
Triathlon Tritanium Knee: Cementless
|
Cohort 2 Cemented
n=134 participants at risk
Enrollment in Cohort 2 (cemented) will begin upon completion of enrollment into the Cohort 1 (cementless), and will continue until a total of 144 cases receive the Triathlon Tibial Tray, Triathlon Patella, Triathlon CR or PS Femur and Triathlon Tibial Insert. All components in this cohort must be used in a cemented application.
Triathlon Knee: Cemented
|
|---|---|---|
|
Cardiac disorders
Non-operative
|
0.31%
1/319 • Number of events 1 • Adverse event data is provided from enrollment through the 8-year postoperative interval for the cementless Cohort 1 with a mean of 4.4 years. For the cemented Cohort 2, the period was from enrollment to the 5.6 years postoperative interval with a mean of 3.1 years.
All operative site events occurring at any time, as well as all serious adverse events (SAEs) occurring in the perioperative period (intraoperative to hospital discharge), are collected. Specific Adverse Event terms are not used for all Adverse Events.
|
0.75%
1/134 • Number of events 1 • Adverse event data is provided from enrollment through the 8-year postoperative interval for the cementless Cohort 1 with a mean of 4.4 years. For the cemented Cohort 2, the period was from enrollment to the 5.6 years postoperative interval with a mean of 3.1 years.
All operative site events occurring at any time, as well as all serious adverse events (SAEs) occurring in the perioperative period (intraoperative to hospital discharge), are collected. Specific Adverse Event terms are not used for all Adverse Events.
|
|
Gastrointestinal disorders
Non-operative
|
0.63%
2/319 • Number of events 2 • Adverse event data is provided from enrollment through the 8-year postoperative interval for the cementless Cohort 1 with a mean of 4.4 years. For the cemented Cohort 2, the period was from enrollment to the 5.6 years postoperative interval with a mean of 3.1 years.
All operative site events occurring at any time, as well as all serious adverse events (SAEs) occurring in the perioperative period (intraoperative to hospital discharge), are collected. Specific Adverse Event terms are not used for all Adverse Events.
|
0.00%
0/134 • Adverse event data is provided from enrollment through the 8-year postoperative interval for the cementless Cohort 1 with a mean of 4.4 years. For the cemented Cohort 2, the period was from enrollment to the 5.6 years postoperative interval with a mean of 3.1 years.
All operative site events occurring at any time, as well as all serious adverse events (SAEs) occurring in the perioperative period (intraoperative to hospital discharge), are collected. Specific Adverse Event terms are not used for all Adverse Events.
|
|
Infections and infestations
Operative site
|
1.3%
4/319 • Number of events 4 • Adverse event data is provided from enrollment through the 8-year postoperative interval for the cementless Cohort 1 with a mean of 4.4 years. For the cemented Cohort 2, the period was from enrollment to the 5.6 years postoperative interval with a mean of 3.1 years.
All operative site events occurring at any time, as well as all serious adverse events (SAEs) occurring in the perioperative period (intraoperative to hospital discharge), are collected. Specific Adverse Event terms are not used for all Adverse Events.
|
0.75%
1/134 • Number of events 1 • Adverse event data is provided from enrollment through the 8-year postoperative interval for the cementless Cohort 1 with a mean of 4.4 years. For the cemented Cohort 2, the period was from enrollment to the 5.6 years postoperative interval with a mean of 3.1 years.
All operative site events occurring at any time, as well as all serious adverse events (SAEs) occurring in the perioperative period (intraoperative to hospital discharge), are collected. Specific Adverse Event terms are not used for all Adverse Events.
|
|
Injury, poisoning and procedural complications
Operative site
|
0.94%
3/319 • Number of events 3 • Adverse event data is provided from enrollment through the 8-year postoperative interval for the cementless Cohort 1 with a mean of 4.4 years. For the cemented Cohort 2, the period was from enrollment to the 5.6 years postoperative interval with a mean of 3.1 years.
All operative site events occurring at any time, as well as all serious adverse events (SAEs) occurring in the perioperative period (intraoperative to hospital discharge), are collected. Specific Adverse Event terms are not used for all Adverse Events.
|
0.75%
1/134 • Number of events 1 • Adverse event data is provided from enrollment through the 8-year postoperative interval for the cementless Cohort 1 with a mean of 4.4 years. For the cemented Cohort 2, the period was from enrollment to the 5.6 years postoperative interval with a mean of 3.1 years.
All operative site events occurring at any time, as well as all serious adverse events (SAEs) occurring in the perioperative period (intraoperative to hospital discharge), are collected. Specific Adverse Event terms are not used for all Adverse Events.
|
|
Musculoskeletal and connective tissue disorders
Operative site
|
3.4%
11/319 • Number of events 11 • Adverse event data is provided from enrollment through the 8-year postoperative interval for the cementless Cohort 1 with a mean of 4.4 years. For the cemented Cohort 2, the period was from enrollment to the 5.6 years postoperative interval with a mean of 3.1 years.
All operative site events occurring at any time, as well as all serious adverse events (SAEs) occurring in the perioperative period (intraoperative to hospital discharge), are collected. Specific Adverse Event terms are not used for all Adverse Events.
|
3.0%
4/134 • Number of events 4 • Adverse event data is provided from enrollment through the 8-year postoperative interval for the cementless Cohort 1 with a mean of 4.4 years. For the cemented Cohort 2, the period was from enrollment to the 5.6 years postoperative interval with a mean of 3.1 years.
All operative site events occurring at any time, as well as all serious adverse events (SAEs) occurring in the perioperative period (intraoperative to hospital discharge), are collected. Specific Adverse Event terms are not used for all Adverse Events.
|
|
Nervous system disorders
Non-operative
|
0.63%
2/319 • Number of events 2 • Adverse event data is provided from enrollment through the 8-year postoperative interval for the cementless Cohort 1 with a mean of 4.4 years. For the cemented Cohort 2, the period was from enrollment to the 5.6 years postoperative interval with a mean of 3.1 years.
All operative site events occurring at any time, as well as all serious adverse events (SAEs) occurring in the perioperative period (intraoperative to hospital discharge), are collected. Specific Adverse Event terms are not used for all Adverse Events.
|
0.75%
1/134 • Number of events 1 • Adverse event data is provided from enrollment through the 8-year postoperative interval for the cementless Cohort 1 with a mean of 4.4 years. For the cemented Cohort 2, the period was from enrollment to the 5.6 years postoperative interval with a mean of 3.1 years.
All operative site events occurring at any time, as well as all serious adverse events (SAEs) occurring in the perioperative period (intraoperative to hospital discharge), are collected. Specific Adverse Event terms are not used for all Adverse Events.
|
|
Renal and urinary disorders
Non-operative
|
0.94%
3/319 • Number of events 3 • Adverse event data is provided from enrollment through the 8-year postoperative interval for the cementless Cohort 1 with a mean of 4.4 years. For the cemented Cohort 2, the period was from enrollment to the 5.6 years postoperative interval with a mean of 3.1 years.
All operative site events occurring at any time, as well as all serious adverse events (SAEs) occurring in the perioperative period (intraoperative to hospital discharge), are collected. Specific Adverse Event terms are not used for all Adverse Events.
|
0.00%
0/134 • Adverse event data is provided from enrollment through the 8-year postoperative interval for the cementless Cohort 1 with a mean of 4.4 years. For the cemented Cohort 2, the period was from enrollment to the 5.6 years postoperative interval with a mean of 3.1 years.
All operative site events occurring at any time, as well as all serious adverse events (SAEs) occurring in the perioperative period (intraoperative to hospital discharge), are collected. Specific Adverse Event terms are not used for all Adverse Events.
|
|
Skin and subcutaneous tissue disorders
Operative site
|
0.31%
1/319 • Number of events 1 • Adverse event data is provided from enrollment through the 8-year postoperative interval for the cementless Cohort 1 with a mean of 4.4 years. For the cemented Cohort 2, the period was from enrollment to the 5.6 years postoperative interval with a mean of 3.1 years.
All operative site events occurring at any time, as well as all serious adverse events (SAEs) occurring in the perioperative period (intraoperative to hospital discharge), are collected. Specific Adverse Event terms are not used for all Adverse Events.
|
0.00%
0/134 • Adverse event data is provided from enrollment through the 8-year postoperative interval for the cementless Cohort 1 with a mean of 4.4 years. For the cemented Cohort 2, the period was from enrollment to the 5.6 years postoperative interval with a mean of 3.1 years.
All operative site events occurring at any time, as well as all serious adverse events (SAEs) occurring in the perioperative period (intraoperative to hospital discharge), are collected. Specific Adverse Event terms are not used for all Adverse Events.
|
|
Surgical and medical procedures
Operative site
|
0.31%
1/319 • Number of events 1 • Adverse event data is provided from enrollment through the 8-year postoperative interval for the cementless Cohort 1 with a mean of 4.4 years. For the cemented Cohort 2, the period was from enrollment to the 5.6 years postoperative interval with a mean of 3.1 years.
All operative site events occurring at any time, as well as all serious adverse events (SAEs) occurring in the perioperative period (intraoperative to hospital discharge), are collected. Specific Adverse Event terms are not used for all Adverse Events.
|
0.00%
0/134 • Adverse event data is provided from enrollment through the 8-year postoperative interval for the cementless Cohort 1 with a mean of 4.4 years. For the cemented Cohort 2, the period was from enrollment to the 5.6 years postoperative interval with a mean of 3.1 years.
All operative site events occurring at any time, as well as all serious adverse events (SAEs) occurring in the perioperative period (intraoperative to hospital discharge), are collected. Specific Adverse Event terms are not used for all Adverse Events.
|
Other adverse events
| Measure |
Cohort 1 Cementless
n=319 participants at risk
Cases are enrolled in the Cohort 1 (cementless) until a total of 356 cases receive the Triathlon Tritanium Tibial Baseplate, Triathlon Tritanium Patella, Triathlon CR or PS Beaded Femur with PA and the Triathlon Tibial Insert. All components in this cohort must used in a cementless application.
Triathlon Tritanium Knee: Cementless
|
Cohort 2 Cemented
n=134 participants at risk
Enrollment in Cohort 2 (cemented) will begin upon completion of enrollment into the Cohort 1 (cementless), and will continue until a total of 144 cases receive the Triathlon Tibial Tray, Triathlon Patella, Triathlon CR or PS Femur and Triathlon Tibial Insert. All components in this cohort must be used in a cemented application.
Triathlon Knee: Cemented
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Operative site
|
21.6%
69/319 • Number of events 89 • Adverse event data is provided from enrollment through the 8-year postoperative interval for the cementless Cohort 1 with a mean of 4.4 years. For the cemented Cohort 2, the period was from enrollment to the 5.6 years postoperative interval with a mean of 3.1 years.
All operative site events occurring at any time, as well as all serious adverse events (SAEs) occurring in the perioperative period (intraoperative to hospital discharge), are collected. Specific Adverse Event terms are not used for all Adverse Events.
|
9.0%
12/134 • Number of events 16 • Adverse event data is provided from enrollment through the 8-year postoperative interval for the cementless Cohort 1 with a mean of 4.4 years. For the cemented Cohort 2, the period was from enrollment to the 5.6 years postoperative interval with a mean of 3.1 years.
All operative site events occurring at any time, as well as all serious adverse events (SAEs) occurring in the perioperative period (intraoperative to hospital discharge), are collected. Specific Adverse Event terms are not used for all Adverse Events.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Each investigator shall have privileges for their own center's results at the completion of the study.These manuscripts \& abstracts will be delayed until after the multi-center publication is submitted.All publications shall be submitted to the sponsor for review at least 60 days prior to the submission for publication.The sponsor shall not edit or otherwise influence the publications other than to ensure that confidential information is not disclosed and that the data is accurately represented.
- Publication restrictions are in place
Restriction type: OTHER