Trial Outcomes & Findings for Computer-Assisted Navigation for Intramedullary Nail Fixation of Intertrochanteric Femur Fractures (NCT NCT02190435)
NCT ID: NCT02190435
Last Updated: 2017-05-24
Results Overview
Distance between lag screw tip and head surface as measured on the ADAPT system
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
65 participants
Primary outcome timeframe
Intraoperative
Results posted on
2017-05-24
Participant Flow
Participant milestones
| Measure |
ADAPT
Patients that receive intramedullary nail fixation with use of the ADAPT system
Stryker ADAPT computer-assisted navigation: Adaptive Positioning Technology for Gamma 3
|
Control
Patients that receive intramedullary nail fixation without use of the ADAPT system
|
|---|---|---|
|
Overall Study
STARTED
|
41
|
24
|
|
Overall Study
COMPLETED
|
26
|
24
|
|
Overall Study
NOT COMPLETED
|
15
|
0
|
Reasons for withdrawal
| Measure |
ADAPT
Patients that receive intramedullary nail fixation with use of the ADAPT system
Stryker ADAPT computer-assisted navigation: Adaptive Positioning Technology for Gamma 3
|
Control
Patients that receive intramedullary nail fixation without use of the ADAPT system
|
|---|---|---|
|
Overall Study
First 12 patients were lead-ins
|
12
|
0
|
|
Overall Study
3 consented screen fails
|
3
|
0
|
Baseline Characteristics
Computer-Assisted Navigation for Intramedullary Nail Fixation of Intertrochanteric Femur Fractures
Baseline characteristics by cohort
| Measure |
ADAPT
n=26 Participants
Patients that receive intramedullary nail fixation with use of the ADAPT system
Stryker ADAPT computer-assisted navigation: Adaptive Positioning Technology for Gamma 3
|
Control
n=24 Participants
Patients that receive intramedullary nail fixation without use of the ADAPT system
|
Total
n=50 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
2 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
4 Participants
n=27 Participants
|
|
Age, Categorical
>=65 years
|
24 Participants
n=93 Participants
|
22 Participants
n=4 Participants
|
46 Participants
n=27 Participants
|
|
Sex: Female, Male
Female
|
19 Participants
n=93 Participants
|
15 Participants
n=4 Participants
|
34 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=93 Participants
|
9 Participants
n=4 Participants
|
16 Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
26 participants
n=93 Participants
|
24 participants
n=4 Participants
|
50 participants
n=27 Participants
|
PRIMARY outcome
Timeframe: IntraoperativeDistance between lag screw tip and head surface as measured on the ADAPT system
Outcome measures
| Measure |
ADAPT
n=26 Participants
Patients that receive intramedullary nail fixation with use of the ADAPT system
Stryker ADAPT computer-assisted navigation: Adaptive Positioning Technology for Gamma 3
|
Control
n=24 Participants
Patients that receive intramedullary nail fixation without use of the ADAPT system
|
|---|---|---|
|
Tip-to-apex Distance
|
14.1 mm
Standard Deviation 3.2
|
14.9 mm
Standard Deviation 3.0
|
SECONDARY outcome
Timeframe: IntraoperativeIntraoperative fluoroscopy exposure time for lag screw placement (seconds)
Outcome measures
| Measure |
ADAPT
n=26 Participants
Patients that receive intramedullary nail fixation with use of the ADAPT system
Stryker ADAPT computer-assisted navigation: Adaptive Positioning Technology for Gamma 3
|
Control
n=24 Participants
Patients that receive intramedullary nail fixation without use of the ADAPT system
|
|---|---|---|
|
Radiation Exposure
|
19.4 seconds
Standard Deviation 8.8
|
18.8 seconds
Standard Deviation 8.0
|
Adverse Events
ADAPT
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control
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
- Publication restrictions are in place