Trial Outcomes & Findings for Study of an Orthotic Designed to Equalize Leg Lengths for Patients With Injuries Managed in Walking Boots (NCT NCT03848949)
NCT ID: NCT03848949
Last Updated: 2021-06-10
Results Overview
Patient reported assessment of their balance while wearing the controlled ankle movement boot on a scale of 1 - 10 (higher values indicate better balance).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
107 participants
Primary outcome timeframe
2 weeks
Results posted on
2021-06-10
Participant Flow
Enrollment continued until the study met protocol requirement.
Participant milestones
| Measure |
Intervention Group
Patients who received the orthotic device
|
Control Group
Patients who did not receive the orthotic device.
|
|---|---|---|
|
Overall Study
STARTED
|
54
|
53
|
|
Overall Study
COMPLETED
|
49
|
46
|
|
Overall Study
NOT COMPLETED
|
5
|
7
|
Reasons for withdrawal
| Measure |
Intervention Group
Patients who received the orthotic device
|
Control Group
Patients who did not receive the orthotic device.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
5
|
7
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Intervention
n=49 Participants
Patients who received the orthotic device.
|
Control
n=46 Participants
Patients who did not receive the orthotic device.
|
Total
n=95 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
47 years
STANDARD_DEVIATION 2.5 • n=49 Participants
|
48.8 years
STANDARD_DEVIATION 2.33 • n=46 Participants
|
47.9 years
STANDARD_DEVIATION 1.7 • n=95 Participants
|
|
Sex: Female, Male
Female
|
32 Participants
n=49 Participants
|
28 Participants
n=46 Participants
|
60 Participants
n=95 Participants
|
|
Sex: Female, Male
Male
|
17 Participants
n=49 Participants
|
18 Participants
n=46 Participants
|
35 Participants
n=95 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
49 participants
n=49 Participants
|
46 participants
n=46 Participants
|
95 participants
n=95 Participants
|
|
Condition: malleolar fracture, foot fracture, ankle fracture, tibiotalar arthritis etc.
Malleolar fracture
|
9 Participants
n=49 Participants
|
10 Participants
n=46 Participants
|
19 Participants
n=95 Participants
|
|
Condition: malleolar fracture, foot fracture, ankle fracture, tibiotalar arthritis etc.
Foot fracture
|
9 Participants
n=49 Participants
|
8 Participants
n=46 Participants
|
17 Participants
n=95 Participants
|
|
Condition: malleolar fracture, foot fracture, ankle fracture, tibiotalar arthritis etc.
Ankle sprain
|
6 Participants
n=49 Participants
|
8 Participants
n=46 Participants
|
14 Participants
n=95 Participants
|
|
Condition: malleolar fracture, foot fracture, ankle fracture, tibiotalar arthritis etc.
Tibiotalar arthritis
|
8 Participants
n=49 Participants
|
1 Participants
n=46 Participants
|
9 Participants
n=95 Participants
|
|
Condition: malleolar fracture, foot fracture, ankle fracture, tibiotalar arthritis etc.
Posterior tibial tendon dysfunction
|
3 Participants
n=49 Participants
|
4 Participants
n=46 Participants
|
7 Participants
n=95 Participants
|
|
Condition: malleolar fracture, foot fracture, ankle fracture, tibiotalar arthritis etc.
Acute Achilles tendon rupture
|
0 Participants
n=49 Participants
|
4 Participants
n=46 Participants
|
4 Participants
n=95 Participants
|
|
Condition: malleolar fracture, foot fracture, ankle fracture, tibiotalar arthritis etc.
Hindfoot arthritis
|
2 Participants
n=49 Participants
|
1 Participants
n=46 Participants
|
3 Participants
n=95 Participants
|
|
Condition: malleolar fracture, foot fracture, ankle fracture, tibiotalar arthritis etc.
Midfoot arthritis
|
1 Participants
n=49 Participants
|
2 Participants
n=46 Participants
|
3 Participants
n=95 Participants
|
|
Condition: malleolar fracture, foot fracture, ankle fracture, tibiotalar arthritis etc.
Peroneal pathology
|
2 Participants
n=49 Participants
|
1 Participants
n=46 Participants
|
3 Participants
n=95 Participants
|
|
Condition: malleolar fracture, foot fracture, ankle fracture, tibiotalar arthritis etc.
Ankle Impingement
|
2 Participants
n=49 Participants
|
1 Participants
n=46 Participants
|
3 Participants
n=95 Participants
|
|
Condition: malleolar fracture, foot fracture, ankle fracture, tibiotalar arthritis etc.
Ankle instability
|
2 Participants
n=49 Participants
|
0 Participants
n=46 Participants
|
2 Participants
n=95 Participants
|
|
Condition: malleolar fracture, foot fracture, ankle fracture, tibiotalar arthritis etc.
Foot sprain
|
0 Participants
n=49 Participants
|
2 Participants
n=46 Participants
|
2 Participants
n=95 Participants
|
|
Condition: malleolar fracture, foot fracture, ankle fracture, tibiotalar arthritis etc.
Other
|
4 Participants
n=49 Participants
|
4 Participants
n=46 Participants
|
8 Participants
n=95 Participants
|
|
Condition: malleolar fracture, foot fracture, ankle fracture, tibiotalar arthritis etc.
Plantar fasciitis
|
1 Participants
n=49 Participants
|
0 Participants
n=46 Participants
|
1 Participants
n=95 Participants
|
|
Condition is tibiotalar or above
Condition at or proximal to tibiotalar joint
|
28 Participants
n=49 Participants
|
26 Participants
n=46 Participants
|
54 Participants
n=95 Participants
|
|
Condition is tibiotalar or above
Condition predominantly below or distal to tibiotalar joint
|
21 Participants
n=49 Participants
|
20 Participants
n=46 Participants
|
41 Participants
n=95 Participants
|
|
Postoperative versus nonoperative management
Postoperative
|
17 Participants
n=49 Participants
|
19 Participants
n=46 Participants
|
36 Participants
n=95 Participants
|
|
Postoperative versus nonoperative management
Nonoperative
|
32 Participants
n=49 Participants
|
27 Participants
n=46 Participants
|
59 Participants
n=95 Participants
|
PRIMARY outcome
Timeframe: 2 weeksPatient reported assessment of their balance while wearing the controlled ankle movement boot on a scale of 1 - 10 (higher values indicate better balance).
Outcome measures
| Measure |
Orthotic Group
n=49 Participants
Subjects enrolled in the orthotic group receive the orthotic (Evenup) meant to increase the effective leg length of the uninjured limb.
Evenup: Orthotic which increases effective leg length.
|
Control
n=46 Participants
Subjects enrolled in the control group receive the standard treatment associated with their injury (no orthotic)
|
|---|---|---|
|
Patient Reported Balance
|
3.0 units on a scale
Standard Deviation 1.7
|
2.1 units on a scale
Standard Deviation 1.7
|
PRIMARY outcome
Timeframe: 2 weeksPatient reported assessment of joint pain while wearing the controlled ankle movement boot on scales of 1 - 10 (higher values indicate more pain).
Outcome measures
| Measure |
Orthotic Group
n=49 Participants
Subjects enrolled in the orthotic group receive the orthotic (Evenup) meant to increase the effective leg length of the uninjured limb.
Evenup: Orthotic which increases effective leg length.
|
Control
n=46 Participants
Subjects enrolled in the control group receive the standard treatment associated with their injury (no orthotic)
|
|---|---|---|
|
Patient Reported Pain
|
4.9 score on a scale
Standard Deviation 5.6
|
3.9 score on a scale
Standard Deviation 5.1
|
Adverse Events
Orthotic Group
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