Trial Outcomes & Findings for Improving the Detection, Classification and Treatment of Misaligned Arthritic Ankles (NCT NCT03440008)
NCT ID: NCT03440008
Last Updated: 2024-12-05
Results Overview
The 3D movement between the tibia and talus bones will be assessed using biplane fluoroscopy, for OA and control subjects during shod gait.
TERMINATED
33 participants
4 hour session
2024-12-05
Participant Flow
Participants were recruited from a combination of clinician introduction to the study, and posted recruitment materials in 2 hospital systems (VA and academic). The study was open for recruitment in 2016 but due to a laboratory move and hardware update, the first participant was not enrolled until February 2019. The last participant was enrolled in March 2020, three days before a local hold on in-person research was enacted due to the COVID-19 pandemic.
Of 33 enrolled participants, 32 proceeded into either control or OA cohorts, one participant withdrew.
Participant milestones
| Measure |
Control
Able-bodied, age matched subjects with no foot and ankle pathology
Dynamic 3D bone motion capture: Two x-ray systems will image the subjects ankle while they walk, allowing us to calculate ankle joint angle and alignment
|
OA (Osteoarthritis)
Subjects with ankle OA, with all classifications of ankle misalignment (varus, neutral, valgus)
Dynamic 3D bone motion capture: Two x-ray systems will image the subjects ankle while they walk, allowing us to calculate ankle joint angle and alignment
wedged insole: medial or lateral wedge (appropriate for varus or valgus misalignment) will be applied during 1 data collection session to evaluate effect of wedging on misalignment
|
|---|---|---|
|
Overall Study
STARTED
|
26
|
7
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
26
|
7
|
Reasons for withdrawal
| Measure |
Control
Able-bodied, age matched subjects with no foot and ankle pathology
Dynamic 3D bone motion capture: Two x-ray systems will image the subjects ankle while they walk, allowing us to calculate ankle joint angle and alignment
|
OA (Osteoarthritis)
Subjects with ankle OA, with all classifications of ankle misalignment (varus, neutral, valgus)
Dynamic 3D bone motion capture: Two x-ray systems will image the subjects ankle while they walk, allowing us to calculate ankle joint angle and alignment
wedged insole: medial or lateral wedge (appropriate for varus or valgus misalignment) will be applied during 1 data collection session to evaluate effect of wedging on misalignment
|
|---|---|---|
|
Overall Study
Cessation of research visits due to COVID-19, PI was transferred to a crisis-response department
|
25
|
7
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
Baseline Characteristics
Improving the Detection, Classification and Treatment of Misaligned Arthritic Ankles
Baseline characteristics by cohort
| Measure |
Control
n=25 Participants
Able-bodied, age matched subjects with no foot and ankle pathology
Dynamic 3D bone motion capture: Two x-ray systems will image the subjects ankle while they walk, allowing us to calculate ankle joint angle and alignment
|
OA (Osteoarthritis)
n=7 Participants
Subjects with ankle OA, with all classifications of ankle misalignment (varus, neutral, valgus)
Dynamic 3D bone motion capture: Two x-ray systems will image the subjects ankle while they walk, allowing us to calculate ankle joint angle and alignment
wedged insole: medial or lateral wedge (appropriate for varus or valgus misalignment) will be applied during 1 data collection session to evaluate effect of wedging on misalignment
|
Total
n=32 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
59.0 Years
n=5 Participants
|
55.4 Years
n=7 Participants
|
58.2 Years
n=5 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
23 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 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
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
6 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
17 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
25 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
|
Varus/Neutral/Valgus Alignment
Varus Misaligned
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Varus/Neutral/Valgus Alignment
Neutral Alignment
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Varus/Neutral/Valgus Alignment
Valgus Misaligned
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Varus/Neutral/Valgus Alignment
Unknown Alignment
|
25 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 4 hour sessionPopulation: Differences in 6 degree-of-freedom motion between the tibia and talus during shod gait (contact phase), between Controls and OA participants. Note that this study was terminated before this data was collected, thus no analysis is available.
The 3D movement between the tibia and talus bones will be assessed using biplane fluoroscopy, for OA and control subjects during shod gait.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: 4 hour sessionPopulation: For OA participants, differences between their static alignment classification, and their dynamically measured varus / neutral / valgus status. Note that this study was terminated before this data was collected, thus no analysis is available.
The sensitivity to correctly diagnose dynamic misalignment by using static x-ray images, will be determined for the OA population.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: 4 hour sessionPopulation: Measure of changes in coronal plane tibio-talar motion in OA population with and without wedged insoles. Note that this study was terminated before this data was collected, thus no analysis is available.
The effect that wedged insoles have on varus / valgus misalignment will be assessed using dynamic 3D x-ray
Outcome measures
Outcome data not reported
Adverse Events
Control
OA (Osteoarthritis)
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