Trial Outcomes & Findings for Adjunct Study of Natrelle(TM) Cohesive Round Silicone-Filled Breast Implants (NCT NCT00691327)
NCT ID: NCT00691327
Last Updated: 2014-10-13
Results Overview
By patient risk of complications occurring in at least 5% of patients in 1 or more cohorts
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
84329 participants
Primary outcome timeframe
5 years
Results posted on
2014-10-13
Participant Flow
Participant milestones
| Measure |
Reconstruction
Women who have undergone Breast Reconstruction
|
Revision
Women who have undergone Revision of a Breast Augmentation or Reconstruction
|
|---|---|---|
|
Overall Study
STARTED
|
45055
|
39274
|
|
Overall Study
COMPLETED
|
42214
|
36766
|
|
Overall Study
NOT COMPLETED
|
2841
|
2508
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Adjunct Study of Natrelle(TM) Cohesive Round Silicone-Filled Breast Implants
Baseline characteristics by cohort
| Measure |
Reconstruction
n=45055 Participants
Women who have undergone Breast Reconstruction
|
Revision
n=39274 Participants
Women who have undergone Revision of a Breast Augmentation or Reconstruction
|
Total
n=84329 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
<=17 years
|
115 participants
n=93 Participants
|
4 participants
n=4 Participants
|
119 participants
n=27 Participants
|
|
Age, Customized
Between 18 and 69 years
|
43304 participants
n=93 Participants
|
37612 participants
n=4 Participants
|
80916 participants
n=27 Participants
|
|
Age, Customized
>=70 years
|
1065 participants
n=93 Participants
|
1039 participants
n=4 Participants
|
2104 participants
n=27 Participants
|
|
Age, Customized
Not provided
|
571 participants
n=93 Participants
|
619 participants
n=4 Participants
|
1190 participants
n=27 Participants
|
|
Sex: Female, Male
Female
|
45055 Participants
n=93 Participants
|
39274 Participants
n=4 Participants
|
84329 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: 5 yearsPopulation: All enrolled patients
By patient risk of complications occurring in at least 5% of patients in 1 or more cohorts
Outcome measures
| Measure |
Reconstruction
n=45055 Participants
Women who have undergone Breast Reconstruction
|
Revision
n=39274 Participants
Women who have undergone Revision of a Breast Augmentation or Reconstruction
|
|---|---|---|
|
Local Complications
Implant Malposition
|
6.5 Percentage by Patient
Interval 6.1 to 6.9
|
7.1 Percentage by Patient
Interval 6.7 to 7.6
|
|
Local Complications
Wrinkling
|
5.6 Percentage by Patient
Interval 5.2 to 6.0
|
8.9 Percentage by Patient
Interval 8.4 to 9.4
|
|
Local Complications
Capsular Contracture
|
15.0 Percentage by Patient
Interval 14.4 to 15.6
|
21.6 Percentage by Patient
Interval 20.8 to 22.3
|
|
Local Complications
Asymmetry
|
11.1 Percentage by Patient
Interval 10.6 to 11.7
|
10.7 Percentage by Patient
Interval 10.1 to 11.2
|
|
Local Complications
Implant Palpability/Visibility
|
7.1 Percentage by Patient
Interval 6.7 to 7.6
|
11.4 Percentage by Patient
Interval 10.9 to 12.1
|
|
Local Complications
Breast Pain
|
5.2 Percentage by Patient
Interval 4.8 to 5.5
|
6.6 Percentage by Patient
Interval 6.1 to 7.0
|
SECONDARY outcome
Timeframe: 5 yearsPopulation: All patients who had a breast implant satisfaction rating
Satisfaction score on a 5-point scale, where 1 is definitely dissatisfied and 5 is definitely satisfied
Outcome measures
| Measure |
Reconstruction
n=7426 Participants
Women who have undergone Breast Reconstruction
|
Revision
n=5691 Participants
Women who have undergone Revision of a Breast Augmentation or Reconstruction
|
|---|---|---|
|
Satisfaction With Breast Implants as Determined by Patients and Physicians on a 5-point Scale
Physician Satisfaction
|
4.4 Units on a scale
Standard Deviation 0.9
|
4.3 Units on a scale
Standard Deviation 1.0
|
|
Satisfaction With Breast Implants as Determined by Patients and Physicians on a 5-point Scale
Patient Satisfaction
|
4.4 Units on a scale
Standard Deviation 0.9
|
4.3 Units on a scale
Standard Deviation 1.0
|
Adverse Events
Reconstruction
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Revision
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.
- Publication restrictions are in place
Restriction type: OTHER