Trial Outcomes & Findings for Skin to Adductor Canal Distance in Various Positions (NCT NCT03562559)
NCT ID: NCT03562559
Last Updated: 2019-09-27
Results Overview
The largest distance disparity as measured from the 5 different leg positions
Recruitment status
COMPLETED
Target enrollment
40 participants
Primary outcome timeframe
Measurements will be made on the day of surgery, no other assessment or follow up needed
Results posted on
2019-09-27
Participant Flow
Patients older than 18 years of age undergoing elective total knee arthroplasty who were able to give informed consent
Participant milestones
| Measure |
TKA Patients
Measurements Using Ultrasound: Ultrasound measurements will be made in 5 positions. The ultrasound probe will be measuring from a fixed external location of the thigh. The 5 positions include: external rotation, neutral, manual tissue external rotation, straight leg raise at 30 degrees and hip/knee flexion at 90 degrees.
|
|---|---|
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Overall Study
STARTED
|
40
|
|
Overall Study
COMPLETED
|
40
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
TKA Patients
n=40 Participants
Measurements Using Ultrasound: Ultrasound measurements will be made in 5 positions. The ultrasound probe will be measuring from a fixed external location of the thigh. The 5 positions include: external rotation, neutral, manual tissue external rotation, straight leg raise at 30 degrees and hip/knee flexion at 90 degrees.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=40 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
18 Participants
n=40 Participants
|
|
Age, Categorical
>=65 years
|
22 Participants
n=40 Participants
|
|
Age, Continuous
|
67.6 years
n=40 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=40 Participants
|
|
Sex: Female, Male
Male
|
23 Participants
n=40 Participants
|
|
Region of Enrollment
Canada
|
40 Participants
n=40 Participants
|
PRIMARY outcome
Timeframe: Measurements will be made on the day of surgery, no other assessment or follow up neededThe largest distance disparity as measured from the 5 different leg positions
Outcome measures
| Measure |
TKA Patients
n=40 Participants
Measurements Using Ultrasound: Ultrasound measurements will be made in 5 positions. The ultrasound probe will be measuring from a fixed external location of the thigh. The 5 positions include: external rotation, neutral, manual tissue external rotation, straight leg raise at 30 degrees and hip/knee flexion at 90 degrees.
|
|---|---|
|
Skin to Adductor Canal Distance Disparity
Neutral vs manual displacement distance (cm)
|
1.01 centimeters
Interval 0.83 to 1.2
|
|
Skin to Adductor Canal Distance Disparity
Neutral vs external rotation distance (cm)
|
0.28 centimeters
Interval 0.16 to 0.39
|
|
Skin to Adductor Canal Distance Disparity
Neutral vs straight leg raise distance (cm)
|
0.43 centimeters
Interval 0.29 to 0.57
|
|
Skin to Adductor Canal Distance Disparity
Neutral vs leg flexion distance (cm)
|
0.63 centimeters
Interval 0.47 to 0.79
|
Adverse Events
TKA Patients
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