Trial Outcomes & Findings for A Multicenter Study to Evaluate Functional Outcome After Knee Replacement (NCT NCT02494544)
NCT ID: NCT02494544
Last Updated: 2025-11-21
Results Overview
Comparing the functional testing differences between iTotal and off the shelf. "Total Functional Activities Score" - a subscale within the Knee Society Score (KSS) with its individual subscale score. The Total Functional Activities Score subscale interprets the functional knee health of each patient via a series of tests such as walking/standing (30 points), standard activities (30 points), advanced activities (25 points), and sports/recreational activities (15 points). Deductions to score are made for factors that limit a patient's mobility, such as needing to use an ambulatory device. The subscale scoring system ranges from 0-100, with higher scores indicating better knee function.
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
215 participants
Primary outcome timeframe
1 year
Results posted on
2025-11-21
Participant Flow
While "Biomet Total Knee Replacement" and "Smith and Nephew Total Knee Replacement" Arms/Groups were listed as possible study groups, no included patients utilized these implant systems. This included patients who failed to meet screening criteria, failed to reach the protocol's required follow-up duration, etc. These arms/groups were only established before the study to represent the possible study groups based on available implant systems on the market.
Participant milestones
| Measure |
ConforMIS iTotal Knee Replacement
iTotal patient-specific knee replacement system
ConforMIS iTotal Knee Replacement: A knee replacement performed with patient specific implant and surgical jigs.
|
DePuy Total Knee Replacement
Off the shelf knee replacement system
Off the Shelf Total Knee Replacement: A knee replacement system by DePuy, Zimmer, Biomet, Smith \& Nephew, or Stryker
|
Zimmer Total Knee Replacement
Off the shelf knee replacement system
Off the Shelf Total Knee Replacement: A knee replacement system by DePuy, Zimmer, Biomet, Smith \& Nephew, or Stryker
|
Biomet Total Knee Replacement
Off the shelf knee replacement system
Off the Shelf Total Knee Replacement: A knee replacement system by DePuy, Zimmer, Biomet, Smith \& Nephew, or Stryker
|
Smith & Nephew Total Knee Replacement
Off the shelf knee replacement system
Off the Shelf Total Knee Replacement: A knee replacement system by DePuy, Zimmer, Biomet, Smith \& Nephew, or Stryker
|
Stryker Total Knee Replacement
Off the shelf knee replacement system
Off the Shelf Total Knee Replacement: A knee replacement system by DePuy, Zimmer, Biomet, Smith \& Nephew, or Stryker
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
131
|
38
|
19
|
0
|
0
|
26
|
|
Overall Study
COMPLETED
|
81
|
28
|
19
|
0
|
0
|
19
|
|
Overall Study
NOT COMPLETED
|
50
|
10
|
0
|
0
|
0
|
7
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Multicenter Study to Evaluate Functional Outcome After Knee Replacement
Baseline characteristics by cohort
| Measure |
ConforMIS iTotal Knee Replacement
n=81 Participants
iTotal patient-specific knee replacement system
ConforMIS iTotal Knee Replacement: A knee replacement performed with patient specific implant and surgical jigs.
|
DePuy Total Knee Replacement
n=28 Participants
Off the shelf knee replacement system
Off the Shelf Total Knee Replacement: A knee replacement system by DePuy, Zimmer, Biomet, Smith \& Nephew, or Stryker
|
Zimmer Total Knee Replacement
n=19 Participants
Off the shelf knee replacement system
Off the Shelf Total Knee Replacement: A knee replacement system by DePuy, Zimmer, Biomet, Smith \& Nephew, or Stryker
|
Biomet Total Knee Replacement
Off the shelf knee replacement system
Off the Shelf Total Knee Replacement: A knee replacement system by DePuy, Zimmer, Biomet, Smith \& Nephew, or Stryker
|
Smith & Nephew Total Knee Replacement
Off the shelf knee replacement system
Off the Shelf Total Knee Replacement: A knee replacement system by DePuy, Zimmer, Biomet, Smith \& Nephew, or Stryker
|
Stryker Total Knee Replacement
n=19 Participants
Off the shelf knee replacement system
Off the Shelf Total Knee Replacement: A knee replacement system by DePuy, Zimmer, Biomet, Smith \& Nephew, or Stryker
|
Total
n=147 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=68 Participants
|
0 Participants
n=76 Participants
|
0 Participants
n=48 Participants
|
0 Participants
n=33 Participants
|
0 Participants
n=225 Participants
|
0 Participants
n=192 Participants
|
0 Participants
n=24 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
42 Participants
n=68 Participants
|
10 Participants
n=76 Participants
|
10 Participants
n=48 Participants
|
0 Participants
n=33 Participants
|
0 Participants
n=225 Participants
|
5 Participants
n=192 Participants
|
67 Participants
n=24 Participants
|
|
Age, Categorical
>=65 years
|
39 Participants
n=68 Participants
|
18 Participants
n=76 Participants
|
9 Participants
n=48 Participants
|
0 Participants
n=33 Participants
|
0 Participants
n=225 Participants
|
14 Participants
n=192 Participants
|
80 Participants
n=24 Participants
|
|
Age, Continuous
|
65.728 years
STANDARD_DEVIATION 7.482 • n=68 Participants
|
67.321 years
STANDARD_DEVIATION 6.842 • n=76 Participants
|
63 years
STANDARD_DEVIATION 8.524 • n=48 Participants
|
—
|
—
|
68.105 years
STANDARD_DEVIATION 6.590 • n=192 Participants
|
65.986 years
STANDARD_DEVIATION 7.468 • n=24 Participants
|
|
Sex: Female, Male
Female
|
45 Participants
n=68 Participants
|
19 Participants
n=76 Participants
|
13 Participants
n=48 Participants
|
—
|
—
|
12 Participants
n=192 Participants
|
89 Participants
n=24 Participants
|
|
Sex: Female, Male
Male
|
36 Participants
n=68 Participants
|
9 Participants
n=76 Participants
|
6 Participants
n=48 Participants
|
—
|
—
|
7 Participants
n=192 Participants
|
58 Participants
n=24 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=68 Participants
|
0 Participants
n=76 Participants
|
0 Participants
n=48 Participants
|
—
|
—
|
0 Participants
n=192 Participants
|
0 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=68 Participants
|
2 Participants
n=76 Participants
|
0 Participants
n=48 Participants
|
—
|
—
|
0 Participants
n=192 Participants
|
2 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=68 Participants
|
0 Participants
n=76 Participants
|
0 Participants
n=48 Participants
|
—
|
—
|
0 Participants
n=192 Participants
|
0 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Black or African American
|
12 Participants
n=68 Participants
|
6 Participants
n=76 Participants
|
0 Participants
n=48 Participants
|
—
|
—
|
2 Participants
n=192 Participants
|
20 Participants
n=24 Participants
|
|
Race (NIH/OMB)
White
|
68 Participants
n=68 Participants
|
16 Participants
n=76 Participants
|
19 Participants
n=48 Participants
|
—
|
—
|
17 Participants
n=192 Participants
|
120 Participants
n=24 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=68 Participants
|
0 Participants
n=76 Participants
|
0 Participants
n=48 Participants
|
—
|
—
|
0 Participants
n=192 Participants
|
0 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=68 Participants
|
4 Participants
n=76 Participants
|
0 Participants
n=48 Participants
|
—
|
—
|
0 Participants
n=192 Participants
|
5 Participants
n=24 Participants
|
|
Region of Enrollment
United States
|
73 participants
n=68 Participants
|
27 participants
n=76 Participants
|
19 participants
n=48 Participants
|
—
|
—
|
10 participants
n=192 Participants
|
128 participants
n=24 Participants
|
|
Region of Enrollment
Germany
|
8 participants
n=68 Participants
|
1 participants
n=76 Participants
|
0 participants
n=48 Participants
|
—
|
—
|
9 participants
n=192 Participants
|
19 participants
n=24 Participants
|
PRIMARY outcome
Timeframe: 1 yearPopulation: Patients that met inclusion criteria and had KSS Total Functional Activities Score.
Comparing the functional testing differences between iTotal and off the shelf. "Total Functional Activities Score" - a subscale within the Knee Society Score (KSS) with its individual subscale score. The Total Functional Activities Score subscale interprets the functional knee health of each patient via a series of tests such as walking/standing (30 points), standard activities (30 points), advanced activities (25 points), and sports/recreational activities (15 points). Deductions to score are made for factors that limit a patient's mobility, such as needing to use an ambulatory device. The subscale scoring system ranges from 0-100, with higher scores indicating better knee function.
Outcome measures
| Measure |
ConforMIS iTotal Knee Replacement
n=73 Participants
iTotal patient-specific knee replacement system
ConforMIS iTotal Knee Replacement: A knee replacement performed with patient specific implant and surgical jigs.
|
DePuy Total Knee Replacement
n=26 Participants
Off the shelf knee replacement system
Off the Shelf Total Knee Replacement: A knee replacement system by DePuy, Zimmer, Biomet, Smith \& Nephew, or Stryker
|
Zimmer Total Knee Replacement
n=18 Participants
Off the shelf knee replacement system
Off the Shelf Total Knee Replacement: A knee replacement system by DePuy, Zimmer, Biomet, Smith \& Nephew, or Stryker
|
Biomet Total Knee Replacement
Off the shelf knee replacement system
Off the Shelf Total Knee Replacement: A knee replacement system by DePuy, Zimmer, Biomet, Smith \& Nephew, or Stryker
|
Smith & Nephew Total Knee Replacement
Off the shelf knee replacement system
Off the Shelf Total Knee Replacement: A knee replacement system by DePuy, Zimmer, Biomet, Smith \& Nephew, or Stryker
|
Stryker Total Knee Replacement
n=15 Participants
Off the shelf knee replacement system
Off the Shelf Total Knee Replacement: A knee replacement system by DePuy, Zimmer, Biomet, Smith \& Nephew, or Stryker
|
|---|---|---|---|---|---|---|
|
Functional Activities Subscale Score Within the Knee Society Score (KSS) Measure
Baseline Score
|
42.34 Score on a subscale
Standard Deviation 16.31
|
40.38 Score on a subscale
Standard Deviation 13.07
|
43.56 Score on a subscale
Standard Deviation 12.38
|
—
|
—
|
38.87 Score on a subscale
Standard Deviation 13.53
|
|
Functional Activities Subscale Score Within the Knee Society Score (KSS) Measure
1 Year Score
|
77.16 Score on a subscale
Standard Deviation 16.47
|
73.65 Score on a subscale
Standard Deviation 16.99
|
88.94 Score on a subscale
Standard Deviation 6.20
|
—
|
—
|
71.20 Score on a subscale
Standard Deviation 23.63
|
|
Functional Activities Subscale Score Within the Knee Society Score (KSS) Measure
Change in Score
|
34.82 Score on a subscale
Standard Deviation 21.73
|
33.27 Score on a subscale
Standard Deviation 18.28
|
45.39 Score on a subscale
Standard Deviation 13.18
|
—
|
—
|
32.33 Score on a subscale
Standard Deviation 19.21
|
SECONDARY outcome
Timeframe: 1 yearPopulation: Patients that met inclusion criteria and had patient satisfaction data were included.
Measuring and comparing the differences between iTotal and off the shelf knees with patient reported outcomes. "Patient Satisfaction", a subscale within the Knee Society Score (KSS), was utilized to capture this metric. The Patient Satisfaction subscale combines scores given for certain responses (very satisfied, satisfied, neutral, somewhat dissatisfied, very dissatisfied) across 5 questions. These questions are designed to determine the level of satisfaction a patient has with their implant across both everyday and active activities. This score ranges from 0-40, with higher scores indicating higher levels of patient satisfaction.
Outcome measures
| Measure |
ConforMIS iTotal Knee Replacement
n=73 Participants
iTotal patient-specific knee replacement system
ConforMIS iTotal Knee Replacement: A knee replacement performed with patient specific implant and surgical jigs.
|
DePuy Total Knee Replacement
n=26 Participants
Off the shelf knee replacement system
Off the Shelf Total Knee Replacement: A knee replacement system by DePuy, Zimmer, Biomet, Smith \& Nephew, or Stryker
|
Zimmer Total Knee Replacement
n=18 Participants
Off the shelf knee replacement system
Off the Shelf Total Knee Replacement: A knee replacement system by DePuy, Zimmer, Biomet, Smith \& Nephew, or Stryker
|
Biomet Total Knee Replacement
Off the shelf knee replacement system
Off the Shelf Total Knee Replacement: A knee replacement system by DePuy, Zimmer, Biomet, Smith \& Nephew, or Stryker
|
Smith & Nephew Total Knee Replacement
Off the shelf knee replacement system
Off the Shelf Total Knee Replacement: A knee replacement system by DePuy, Zimmer, Biomet, Smith \& Nephew, or Stryker
|
Stryker Total Knee Replacement
n=15 Participants
Off the shelf knee replacement system
Off the Shelf Total Knee Replacement: A knee replacement system by DePuy, Zimmer, Biomet, Smith \& Nephew, or Stryker
|
|---|---|---|---|---|---|---|
|
Patient Satisfaction Subscale Score Within the Knee Society Score (KSS) Measure
1 Year Score
|
33.78 score on a scale
Standard Deviation 8.28
|
32.00 score on a scale
Standard Deviation 7.80
|
37.44 score on a scale
Standard Deviation 3.81
|
—
|
—
|
32.93 score on a scale
Standard Deviation 6.84
|
|
Patient Satisfaction Subscale Score Within the Knee Society Score (KSS) Measure
Baseline Score
|
12.49 score on a scale
Standard Deviation 7.09
|
13.62 score on a scale
Standard Deviation 6.50
|
15.67 score on a scale
Standard Deviation 7.65
|
—
|
—
|
15.50 score on a scale
Standard Deviation 6.67
|
|
Patient Satisfaction Subscale Score Within the Knee Society Score (KSS) Measure
Change in Score
|
21.29 score on a scale
Standard Deviation 10.76
|
18.38 score on a scale
Standard Deviation 9.63
|
21.78 score on a scale
Standard Deviation 8.08
|
—
|
—
|
17.73 score on a scale
Standard Deviation 8.71
|
SECONDARY outcome
Timeframe: 1 yearPopulation: No included patients utilized the Biomet or Smith \& Nephew total knee replacement systems.
All complications were stratified according to clinicaltrials.gov reporting standards and each site labeled each complication as either device-related, non-device-related, procedure-related, and non-procedure-related.
Outcome measures
| Measure |
ConforMIS iTotal Knee Replacement
n=81 Participants
iTotal patient-specific knee replacement system
ConforMIS iTotal Knee Replacement: A knee replacement performed with patient specific implant and surgical jigs.
|
DePuy Total Knee Replacement
n=28 Participants
Off the shelf knee replacement system
Off the Shelf Total Knee Replacement: A knee replacement system by DePuy, Zimmer, Biomet, Smith \& Nephew, or Stryker
|
Zimmer Total Knee Replacement
n=19 Participants
Off the shelf knee replacement system
Off the Shelf Total Knee Replacement: A knee replacement system by DePuy, Zimmer, Biomet, Smith \& Nephew, or Stryker
|
Biomet Total Knee Replacement
Off the shelf knee replacement system
Off the Shelf Total Knee Replacement: A knee replacement system by DePuy, Zimmer, Biomet, Smith \& Nephew, or Stryker
|
Smith & Nephew Total Knee Replacement
Off the shelf knee replacement system
Off the Shelf Total Knee Replacement: A knee replacement system by DePuy, Zimmer, Biomet, Smith \& Nephew, or Stryker
|
Stryker Total Knee Replacement
n=19 Participants
Off the shelf knee replacement system
Off the Shelf Total Knee Replacement: A knee replacement system by DePuy, Zimmer, Biomet, Smith \& Nephew, or Stryker
|
|---|---|---|---|---|---|---|
|
Incidents of Major Procedure-related and Device Related Complications (Including Revision Rates)
Device Related Complications (including revision)
|
1 Patients with Events
|
0 Patients with Events
|
0 Patients with Events
|
—
|
—
|
0 Patients with Events
|
|
Incidents of Major Procedure-related and Device Related Complications (Including Revision Rates)
Major Procedure Related Complications
|
12 Patients with Events
|
5 Patients with Events
|
1 Patients with Events
|
—
|
—
|
3 Patients with Events
|
Adverse Events
ConforMIS iTotal Knee Replacement
Serious events: 13 serious events
Other events: 26 other events
Deaths: 0 deaths
DePuy Total Knee Replacement
Serious events: 6 serious events
Other events: 7 other events
Deaths: 0 deaths
Zimmer Total Knee Replacement
Serious events: 2 serious events
Other events: 1 other events
Deaths: 0 deaths
Biomet Total Knee Replacement
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Smith & Nephew Total Knee Replacement
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Stryker Total Knee Replacement
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
ConforMIS iTotal Knee Replacement
n=81 participants at risk
iTotal patient-specific knee replacement system
ConforMIS iTotal Knee Replacement: A knee replacement performed with patient specific implant and surgical jigs.
|
DePuy Total Knee Replacement
n=28 participants at risk
Off the shelf knee replacement system
Off the Shelf Total Knee Replacement: A knee replacement system by DePuy, Zimmer, Biomet, Smith \& Nephew, or Stryker
|
Zimmer Total Knee Replacement
n=19 participants at risk
Off the shelf knee replacement system
Off the Shelf Total Knee Replacement: A knee replacement system by DePuy, Zimmer, Biomet, Smith \& Nephew, or Stryker
|
Biomet Total Knee Replacement
Off the shelf knee replacement system
Off the Shelf Total Knee Replacement: A knee replacement system by DePuy, Zimmer, Biomet, Smith \& Nephew, or Stryker
|
Smith & Nephew Total Knee Replacement
Off the shelf knee replacement system
Off the Shelf Total Knee Replacement: A knee replacement system by DePuy, Zimmer, Biomet, Smith \& Nephew, or Stryker
|
Stryker Total Knee Replacement
n=19 participants at risk
Off the shelf knee replacement system
Off the Shelf Total Knee Replacement: A knee replacement system by DePuy, Zimmer, Biomet, Smith \& Nephew, or Stryker
|
|---|---|---|---|---|---|---|
|
General disorders
SAS
|
16.0%
13/81 • 1 year post-operation.
Adverse event collection followed the definitions given on clinicaltrials.gov
|
21.4%
6/28 • 1 year post-operation.
Adverse event collection followed the definitions given on clinicaltrials.gov
|
10.5%
2/19 • 1 year post-operation.
Adverse event collection followed the definitions given on clinicaltrials.gov
|
—
0/0 • 1 year post-operation.
Adverse event collection followed the definitions given on clinicaltrials.gov
|
—
0/0 • 1 year post-operation.
Adverse event collection followed the definitions given on clinicaltrials.gov
|
0.00%
0/19 • 1 year post-operation.
Adverse event collection followed the definitions given on clinicaltrials.gov
|
Other adverse events
| Measure |
ConforMIS iTotal Knee Replacement
n=81 participants at risk
iTotal patient-specific knee replacement system
ConforMIS iTotal Knee Replacement: A knee replacement performed with patient specific implant and surgical jigs.
|
DePuy Total Knee Replacement
n=28 participants at risk
Off the shelf knee replacement system
Off the Shelf Total Knee Replacement: A knee replacement system by DePuy, Zimmer, Biomet, Smith \& Nephew, or Stryker
|
Zimmer Total Knee Replacement
n=19 participants at risk
Off the shelf knee replacement system
Off the Shelf Total Knee Replacement: A knee replacement system by DePuy, Zimmer, Biomet, Smith \& Nephew, or Stryker
|
Biomet Total Knee Replacement
Off the shelf knee replacement system
Off the Shelf Total Knee Replacement: A knee replacement system by DePuy, Zimmer, Biomet, Smith \& Nephew, or Stryker
|
Smith & Nephew Total Knee Replacement
Off the shelf knee replacement system
Off the Shelf Total Knee Replacement: A knee replacement system by DePuy, Zimmer, Biomet, Smith \& Nephew, or Stryker
|
Stryker Total Knee Replacement
n=19 participants at risk
Off the shelf knee replacement system
Off the Shelf Total Knee Replacement: A knee replacement system by DePuy, Zimmer, Biomet, Smith \& Nephew, or Stryker
|
|---|---|---|---|---|---|---|
|
Infections and infestations
Infection-related Complication
|
6.2%
5/81 • Number of events 5 • 1 year post-operation.
Adverse event collection followed the definitions given on clinicaltrials.gov
|
0.00%
0/28 • 1 year post-operation.
Adverse event collection followed the definitions given on clinicaltrials.gov
|
0.00%
0/19 • 1 year post-operation.
Adverse event collection followed the definitions given on clinicaltrials.gov
|
—
0/0 • 1 year post-operation.
Adverse event collection followed the definitions given on clinicaltrials.gov
|
—
0/0 • 1 year post-operation.
Adverse event collection followed the definitions given on clinicaltrials.gov
|
5.3%
1/19 • Number of events 1 • 1 year post-operation.
Adverse event collection followed the definitions given on clinicaltrials.gov
|
|
General disorders
Wound Complications
|
6.2%
5/81 • Number of events 5 • 1 year post-operation.
Adverse event collection followed the definitions given on clinicaltrials.gov
|
0.00%
0/28 • 1 year post-operation.
Adverse event collection followed the definitions given on clinicaltrials.gov
|
0.00%
0/19 • 1 year post-operation.
Adverse event collection followed the definitions given on clinicaltrials.gov
|
—
0/0 • 1 year post-operation.
Adverse event collection followed the definitions given on clinicaltrials.gov
|
—
0/0 • 1 year post-operation.
Adverse event collection followed the definitions given on clinicaltrials.gov
|
5.3%
1/19 • Number of events 1 • 1 year post-operation.
Adverse event collection followed the definitions given on clinicaltrials.gov
|
|
Vascular disorders
Thrombotic Complications
|
0.00%
0/81 • 1 year post-operation.
Adverse event collection followed the definitions given on clinicaltrials.gov
|
0.00%
0/28 • 1 year post-operation.
Adverse event collection followed the definitions given on clinicaltrials.gov
|
0.00%
0/19 • 1 year post-operation.
Adverse event collection followed the definitions given on clinicaltrials.gov
|
—
0/0 • 1 year post-operation.
Adverse event collection followed the definitions given on clinicaltrials.gov
|
—
0/0 • 1 year post-operation.
Adverse event collection followed the definitions given on clinicaltrials.gov
|
10.5%
2/19 • Number of events 2 • 1 year post-operation.
Adverse event collection followed the definitions given on clinicaltrials.gov
|
|
Musculoskeletal and connective tissue disorders
Pain/Stiffness Complications
|
4.9%
4/81 • Number of events 4 • 1 year post-operation.
Adverse event collection followed the definitions given on clinicaltrials.gov
|
7.1%
2/28 • Number of events 2 • 1 year post-operation.
Adverse event collection followed the definitions given on clinicaltrials.gov
|
0.00%
0/19 • 1 year post-operation.
Adverse event collection followed the definitions given on clinicaltrials.gov
|
—
0/0 • 1 year post-operation.
Adverse event collection followed the definitions given on clinicaltrials.gov
|
—
0/0 • 1 year post-operation.
Adverse event collection followed the definitions given on clinicaltrials.gov
|
0.00%
0/19 • 1 year post-operation.
Adverse event collection followed the definitions given on clinicaltrials.gov
|
|
Injury, poisoning and procedural complications
Procedure Related Complication
|
14.8%
12/81 • Number of events 12 • 1 year post-operation.
Adverse event collection followed the definitions given on clinicaltrials.gov
|
17.9%
5/28 • Number of events 5 • 1 year post-operation.
Adverse event collection followed the definitions given on clinicaltrials.gov
|
5.3%
1/19 • Number of events 1 • 1 year post-operation.
Adverse event collection followed the definitions given on clinicaltrials.gov
|
—
0/0 • 1 year post-operation.
Adverse event collection followed the definitions given on clinicaltrials.gov
|
—
0/0 • 1 year post-operation.
Adverse event collection followed the definitions given on clinicaltrials.gov
|
15.8%
3/19 • Number of events 3 • 1 year post-operation.
Adverse event collection followed the definitions given on clinicaltrials.gov
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place