Trial Outcomes & Findings for Computer-Assisted Fixation of Trochanteric Femur Fractures (NCT NCT04528459)
NCT ID: NCT04528459
Last Updated: 2025-03-04
Results Overview
Tip-apex distance of the lag screw in the femoral head as measured on postoperative anteroposterior and lateral x-rays
TERMINATED
NA
12 participants
Immediate post-operative period
2025-03-04
Participant Flow
Participant milestones
| Measure |
Traditional Fluoroscopy
Cohort 1 will consist of patients with closed peritrochanteric femur fractures who undergo open reduction internal fixation with a Stryker© Gamma™ cephalomedullary nail using traditional fluoroscopy for insertion of the lag screw (current standard of care).
|
Stryker© ADAPT™ Platform
Cohort 2 will consist of patients with closed peritrochanteric femur fractures who undergo open reduction internal fixation with a Stryker© Gamma™ cephalomedullary nail using the Stryker© ADAPT™ platform to assist with insertion of the lag screw.
|
|---|---|---|
|
Overall Study
STARTED
|
6
|
6
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
6
|
6
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Computer-Assisted Fixation of Trochanteric Femur Fractures
Baseline characteristics by cohort
| Measure |
Traditional Fluoroscopy
n=6 Participants
Cohort 1 will consist of patients with closed peritrochanteric femur fractures who undergo open reduction internal fixation with a Stryker© Gamma™ cephalomedullary nail using traditional fluoroscopy for insertion of the lag screw (current standard of care).
|
Stryker© ADAPT™ Platform
n=6 Participants
Cohort 2 will consist of patients with closed peritrochanteric femur fractures who undergo open reduction internal fixation with a Stryker© Gamma™ cephalomedullary nail using the Stryker© ADAPT™ platform to assist with insertion of the lag screw.
|
Total
n=12 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
82.7 years
STANDARD_DEVIATION 12.5 • n=99 Participants
|
82.0 years
STANDARD_DEVIATION 14.6 • n=107 Participants
|
82.3 years
STANDARD_DEVIATION 13.0 • n=206 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
4 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
6 participants
n=99 Participants
|
6 participants
n=107 Participants
|
12 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Immediate post-operative periodPopulation: Data was not collected. Participants were enrolled and randomized prior to the study termination but were not administered the study intervention.
Tip-apex distance of the lag screw in the femoral head as measured on postoperative anteroposterior and lateral x-rays
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Immediate postoperative periodPopulation: Data was not collected. Participants were enrolled and randomized prior to the study termination but were not administered the study intervention.
Lag screw position in the femoral head/neck as described by Cleveland et al. (1959)
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Intraoperative periodPopulation: Data was not collected. Participants were enrolled and randomized prior to the study termination but were not administered the study intervention.
The amount of time required to complete the surgical procedure
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Intraoperative periodPopulation: Data was not collected. Participants were enrolled and randomized prior to the study termination but were not administered the study intervention.
The amount of fluoroscopy utilized during the surgical procedure as measured in seconds
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Intraoperative periodPopulation: Data was not collected. Participants were enrolled and randomized prior to the study termination but were not administered the study intervention.
The total number of K-wire passes prior to final lag screw placement
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 3 months, 6 months, 1 year, and 2 years after surgeryPopulation: Data was not collected. Participants were enrolled and randomized prior to the study termination but were not administered the study intervention.
Evidence of lag screw cut-out as seen on postoperative hip radiographs
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 3 months, 6 months, 1 year, and 2 years after surgeryPopulation: Data was not collected. Participants were enrolled and randomized prior to the study termination but were not administered the study intervention.
Postoperative range of motion of the affected hip as measured on physical examination
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 3 months, 6 months, 1 year, and 2 years after surgeryPopulation: Data was not collected. Participants were enrolled and randomized prior to the study termination but were not administered the study intervention.
Postoperative patient mobility and social dependency as defined by the Harris Hip Score
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 3 months, 6 months, 1 year, and 2 years after surgeryPopulation: Data was not collected. Participants were enrolled and randomized prior to the study termination but were not administered the study intervention.
Postoperative pain level as defined by the visual analog scale
Outcome measures
Outcome data not reported
Adverse Events
Traditional Fluoroscopy
Stryker© ADAPT™ Platform
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