Trial Outcomes & Findings for Even-Up to Minimize Secondary Site Pain For Ankle Fracture (NCT NCT04164563)
NCT ID: NCT04164563
Last Updated: 2022-10-18
Results Overview
Visual Analog Scale (0 - 100) to assess pain at various musculoskeletal sites. Patients are presented with a slider on a scale to indicate the degree to which they are experiencing pain on a scale from "No Pain" at the far left to "Worst Pain" at the far right. The position on the scale is then translated into a number from 0 (no pain) to 100 (worst pain).
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
6 participants
Primary outcome timeframe
0-24 weeks
Results posted on
2022-10-18
Participant Flow
Participant milestones
| Measure |
Group I: CAM Walker Boot
Patients in Group I were assigned to receive a course of CAM walker boot treatment for a period of six weeks.
|
Group II: CAM+EVENup Orthotic Shoe Lift
Patients in Group II were assigned to receive a course of CAM walker boot treatment with an EVENup orthotic shoe lift to be worn on the contralateral foot for a period of six weeks.
|
|---|---|---|
|
Overall Study
STARTED
|
3
|
3
|
|
Overall Study
COMPLETED
|
3
|
3
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Even-Up to Minimize Secondary Site Pain For Ankle Fracture
Baseline characteristics by cohort
| Measure |
Group I: CAM Walker Boot
n=3 Participants
Patients in Group I were assigned to receive a course of CAM walker boot treatment for a period of six weeks.
|
Group II: CAM+EVENup Orthotic Shoe Lift
n=3 Participants
Patients in Group II were assigned to receive a course of CAM walker boot treatment with an EVENup orthotic shoe lift to be worn on the contralateral foot for a period of six weeks.
|
Total
n=6 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
36 years
STANDARD_DEVIATION 17.1 • n=5 Participants
|
48 years
STANDARD_DEVIATION 21.9 • n=7 Participants
|
42 years
STANDARD_DEVIATION 18.8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
3 participants
n=5 Participants
|
3 participants
n=7 Participants
|
6 participants
n=5 Participants
|
|
FAAM (0 - 100)
|
33.7 units on a scale
STANDARD_DEVIATION 14.1 • n=5 Participants
|
46.8 units on a scale
STANDARD_DEVIATION 24.2 • n=7 Participants
|
40.3 units on a scale
STANDARD_DEVIATION 19.1 • n=5 Participants
|
PRIMARY outcome
Timeframe: 0-24 weeksVisual Analog Scale (0 - 100) to assess pain at various musculoskeletal sites. Patients are presented with a slider on a scale to indicate the degree to which they are experiencing pain on a scale from "No Pain" at the far left to "Worst Pain" at the far right. The position on the scale is then translated into a number from 0 (no pain) to 100 (worst pain).
Outcome measures
| Measure |
Group I
n=3 Participants
Patients in Group I were assigned to receive a course of CAM walker boot treatment for a period of six weeks.
|
Group II
n=3 Participants
Patients in Group II were assigned to receive a course of CAM walker boot treatment with an EVENup orthotic shoe lift to be worn on the contralateral foot for a period of six weeks.
|
|---|---|---|
|
Patient Reported Pain (VAS)
0 weeks - Right Knee
|
2 score on a scale
Standard Deviation 3.5
|
0 score on a scale
Standard Deviation 0
|
|
Patient Reported Pain (VAS)
6 weeks - Left Knee
|
0 score on a scale
Standard Deviation 0
|
16.7 score on a scale
Standard Deviation 28.9
|
|
Patient Reported Pain (VAS)
0 weeks - Lower Back
|
0 score on a scale
Standard Deviation 0
|
0 score on a scale
Standard Deviation 0
|
|
Patient Reported Pain (VAS)
0 weeks - Right Hip
|
0 score on a scale
Standard Deviation 0
|
0 score on a scale
Standard Deviation 0
|
|
Patient Reported Pain (VAS)
0 weeks - Left Hip
|
11 score on a scale
Standard Deviation 19.1
|
0 score on a scale
Standard Deviation 0
|
|
Patient Reported Pain (VAS)
0 weeks - Left Knee
|
0 score on a scale
Standard Deviation 0
|
0 score on a scale
Standard Deviation 0
|
|
Patient Reported Pain (VAS)
0 weeks - Right Ankle
|
12.7 score on a scale
Standard Deviation 21.9
|
29.7 score on a scale
Standard Deviation 30.5
|
|
Patient Reported Pain (VAS)
0 weeks - Left Ankle
|
15.7 score on a scale
Standard Deviation 27.1
|
0 score on a scale
Standard Deviation 0
|
|
Patient Reported Pain (VAS)
0 weeks - Right Foot
|
0 score on a scale
Standard Deviation 0
|
26.7 score on a scale
Standard Deviation 46.2
|
|
Patient Reported Pain (VAS)
0 weeks - Left Foot
|
3.7 score on a scale
Standard Deviation 6.3
|
0 score on a scale
Standard Deviation 0
|
|
Patient Reported Pain (VAS)
6 weeks - Lower Back
|
0 score on a scale
Standard Deviation 0
|
0 score on a scale
Standard Deviation 0
|
|
Patient Reported Pain (VAS)
6 weeks - Right Hip
|
0 score on a scale
Standard Deviation 0
|
0 score on a scale
Standard Deviation 0
|
|
Patient Reported Pain (VAS)
6 weeks - Left Hip
|
1.7 score on a scale
Standard Deviation 2.9
|
3.3 score on a scale
Standard Deviation 5.8
|
|
Patient Reported Pain (VAS)
6 weeks - Right Knee
|
2 score on a scale
Standard Deviation 3.5
|
0 score on a scale
Standard Deviation 0
|
|
Patient Reported Pain (VAS)
6 weeks - Right Ankle
|
0 score on a scale
Standard Deviation 0
|
3.3 score on a scale
Standard Deviation 5.8
|
|
Patient Reported Pain (VAS)
6 weeks - Left Ankle
|
10.3 score on a scale
Standard Deviation 17.9
|
0 score on a scale
Standard Deviation 0
|
|
Patient Reported Pain (VAS)
6 weeks - Right Foot
|
0 score on a scale
Standard Deviation 0
|
4.7 score on a scale
Standard Deviation 8.1
|
|
Patient Reported Pain (VAS)
6 weeks - Left Foot
|
4 score on a scale
Standard Deviation 6.9
|
0 score on a scale
Standard Deviation 0
|
|
Patient Reported Pain (VAS)
12 weeks - Lower Back
|
0 score on a scale
Standard Deviation 0
|
0 score on a scale
Standard Deviation 0
|
|
Patient Reported Pain (VAS)
12 weeks - Right Hip
|
0 score on a scale
Standard Deviation 0
|
0 score on a scale
Standard Deviation 0
|
|
Patient Reported Pain (VAS)
12 weeks - Left Hip
|
0 score on a scale
Standard Deviation 0
|
0 score on a scale
Standard Deviation 0
|
|
Patient Reported Pain (VAS)
12 weeks - Right Knee
|
0 score on a scale
Standard Deviation 0
|
0 score on a scale
Standard Deviation 0
|
|
Patient Reported Pain (VAS)
12 weeks - Left Knee
|
0 score on a scale
Standard Deviation 0
|
0 score on a scale
Standard Deviation 0
|
|
Patient Reported Pain (VAS)
12 weeks - Right Ankle
|
7.7 score on a scale
Standard Deviation 13.3
|
4.7 score on a scale
Standard Deviation 8.1
|
|
Patient Reported Pain (VAS)
12 weeks - Left Ankle
|
6.7 score on a scale
Standard Deviation 11.5
|
0 score on a scale
Standard Deviation 0
|
|
Patient Reported Pain (VAS)
12 weeks - Right Foot
|
0 score on a scale
Standard Deviation 0
|
5.7 score on a scale
Standard Deviation 9.8
|
|
Patient Reported Pain (VAS)
12 weeks - Left Foot
|
2 score on a scale
Standard Deviation 3.5
|
0 score on a scale
Standard Deviation 0
|
|
Patient Reported Pain (VAS)
24 weeks - Lower Back
|
0 score on a scale
Standard Deviation 0
|
0 score on a scale
Standard Deviation 0
|
|
Patient Reported Pain (VAS)
24 weeks - Right Hip
|
0 score on a scale
Standard Deviation 0
|
0 score on a scale
Standard Deviation 0
|
|
Patient Reported Pain (VAS)
24 weeks - Left Hip
|
0 score on a scale
Standard Deviation 0
|
0 score on a scale
Standard Deviation 0
|
|
Patient Reported Pain (VAS)
24 weeks - Right Knee
|
0 score on a scale
Standard Deviation 0
|
0 score on a scale
Standard Deviation 0
|
|
Patient Reported Pain (VAS)
24 weeks - Left Knee
|
9.7 score on a scale
Standard Deviation 16.7
|
0 score on a scale
Standard Deviation 0
|
|
Patient Reported Pain (VAS)
24 weeks - Right Ankle
|
1.3 score on a scale
Standard Deviation 2.3
|
0 score on a scale
Standard Deviation 0
|
|
Patient Reported Pain (VAS)
24 weeks - Left Ankle
|
4 score on a scale
Standard Deviation 6.9
|
0 score on a scale
Standard Deviation 0
|
|
Patient Reported Pain (VAS)
24 weeks - Right Foot
|
0 score on a scale
Standard Deviation 0
|
3.7 score on a scale
Standard Deviation 6.4
|
|
Patient Reported Pain (VAS)
24 weeks - Left Foot
|
0 score on a scale
Standard Deviation 0
|
0 score on a scale
Standard Deviation 0
|
PRIMARY outcome
Timeframe: 0-24 weeksFAAM-ADL (Foot and Ankle Ability Measure - Activities of Daily Living, \[0 -100\]).The FAAM-ADL consists of 21 questions, with a maximum score of 4 per question. The sum of the scores of answered questions is divided by the highest potential score (84 if all 21 questions are answered) and converted to a total score out of 100, with a minimum score of 0. Higher scores indicate better function. Total score range is 0 to 100.
Outcome measures
| Measure |
Group I
n=3 Participants
Patients in Group I were assigned to receive a course of CAM walker boot treatment for a period of six weeks.
|
Group II
n=3 Participants
Patients in Group II were assigned to receive a course of CAM walker boot treatment with an EVENup orthotic shoe lift to be worn on the contralateral foot for a period of six weeks.
|
|---|---|---|
|
Patient Reported Outcome (FAAM-ADL, 0 - 100)
12 weeks
|
86.1 score on a scale
Standard Deviation 14.8
|
97.2 score on a scale
Standard Deviation 2.5
|
|
Patient Reported Outcome (FAAM-ADL, 0 - 100)
0 weeks
|
33.7 score on a scale
Standard Deviation 14.1
|
46.8 score on a scale
Standard Deviation 24.2
|
|
Patient Reported Outcome (FAAM-ADL, 0 - 100)
6 weeks
|
59.9 score on a scale
Standard Deviation 4.8
|
88.9 score on a scale
Standard Deviation 8.1
|
|
Patient Reported Outcome (FAAM-ADL, 0 - 100)
24 weeks
|
92.9 score on a scale
Standard Deviation 6.2
|
99.6 score on a scale
Standard Deviation 0.7
|
Adverse Events
Group I: CAM Walker Boot
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Group II: CAM+EVENup Orthotic Shoe Lift
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