Trial Outcomes & Findings for 3D X-ray Motion Analysis of Ankle-foot Motion After Total Ankle Arthroplasty (NCT NCT03575975)
NCT ID: NCT03575975
Last Updated: 2021-05-28
Results Overview
3D range of motions of the tibiotalar (upper ankle) joint were recorded and analyzed using a biplanar x-ray motion analysis system. In particular, joint ranges of motion were tested in terms of dorsiflexion-plantarflexion, internal-external rotation, and inversion-eversion angles.
Recruitment status
TERMINATED
Target enrollment
9 participants
Primary outcome timeframe
1 year
Results posted on
2021-05-28
Participant Flow
Participant milestones
| Measure |
Mobile-bearing Ankle Prosthesis User
Users of the Stryker Scandinavian Total Ankle Replacement (STAR) mobile-bearing prosthesis.
Total Ankle Replacement Prosthesis: Comparison of functional range of motion in users of Stryker Scandinavian Total Ankle Replacement (STAR) prosthesis to users of INBONE 2 Total Ankle Replacement prosthesis and to matched controls with intact ankle joints.
|
Fixed-bearing Ankle Prosthesis User
Users of the INBONE II Total Ankle Replacement fixed-bearing prosthesis.
Total Ankle Replacement Prosthesis: Comparison of functional range of motion in users of Stryker Scandinavian Total Ankle Replacement (STAR) prosthesis to users of INBONE 2 Total Ankle Replacement prosthesis and to matched controls with intact ankle joints.
|
Control
Healthy individual age- and gender-matched to a participant in the mobile-bearing prosthesis user group.
|
|---|---|---|---|
|
Overall Study
STARTED
|
4
|
5
|
0
|
|
Overall Study
COMPLETED
|
3
|
5
|
0
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
0
|
Reasons for withdrawal
| Measure |
Mobile-bearing Ankle Prosthesis User
Users of the Stryker Scandinavian Total Ankle Replacement (STAR) mobile-bearing prosthesis.
Total Ankle Replacement Prosthesis: Comparison of functional range of motion in users of Stryker Scandinavian Total Ankle Replacement (STAR) prosthesis to users of INBONE 2 Total Ankle Replacement prosthesis and to matched controls with intact ankle joints.
|
Fixed-bearing Ankle Prosthesis User
Users of the INBONE II Total Ankle Replacement fixed-bearing prosthesis.
Total Ankle Replacement Prosthesis: Comparison of functional range of motion in users of Stryker Scandinavian Total Ankle Replacement (STAR) prosthesis to users of INBONE 2 Total Ankle Replacement prosthesis and to matched controls with intact ankle joints.
|
Control
Healthy individual age- and gender-matched to a participant in the mobile-bearing prosthesis user group.
|
|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
0
|
Baseline Characteristics
3D X-ray Motion Analysis of Ankle-foot Motion After Total Ankle Arthroplasty
Baseline characteristics by cohort
| Measure |
Mobile-bearing Ankle Prosthesis User
n=4 Participants
Users of the Stryker Scandinavian Total Ankle Replacement (STAR) mobile-bearing prosthesis.
Total Ankle Replacement Prosthesis: Comparison of functional range of motion in users of Stryker Scandinavian Total Ankle Replacement (STAR) prosthesis to users of INBONE 2 Total Ankle Replacement prosthesis and to matched controls with intact ankle joints.
|
Fixed-bearing Ankle Prosthesis User
n=5 Participants
Users of the INBONE II Total Ankle Replacement fixed-bearing prosthesis.
Total Ankle Replacement Prosthesis: Comparison of functional range of motion in users of Stryker Scandinavian Total Ankle Replacement (STAR) prosthesis to users of INBONE 2 Total Ankle Replacement prosthesis and to matched controls with intact ankle joints.
|
Control
Healthy individual age- and gender-matched to a participant in the mobile-bearing prosthesis user group.
No participants were enrolled due to premature study termination.
|
Total
n=9 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
67.8 years
STANDARD_DEVIATION 12.6 • n=5 Participants
|
70.0 years
STANDARD_DEVIATION 7.5 • n=7 Participants
|
—
|
69.0 years
STANDARD_DEVIATION 9.5 • n=4 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
—
|
6 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
—
|
3 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
—
|
0 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
—
|
0 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
—
|
9 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
4 participants
n=5 Participants
|
5 participants
n=7 Participants
|
—
|
9 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 1 yearPopulation: All participants who completed all aspects of the study protocol.
3D range of motions of the tibiotalar (upper ankle) joint were recorded and analyzed using a biplanar x-ray motion analysis system. In particular, joint ranges of motion were tested in terms of dorsiflexion-plantarflexion, internal-external rotation, and inversion-eversion angles.
Outcome measures
| Measure |
Mobile-bearing Ankle Prosthesis User
n=3 Participants
Users of the Stryker Scandinavian Total Ankle Replacement (STAR) mobile-bearing prosthesis.
Total Ankle Replacement Prosthesis: Comparison of functional range of motion in users of Stryker Scandinavian Total Ankle Replacement (STAR) prosthesis to users of INBONE 2 Total Ankle Replacement prosthesis and to matched controls with intact ankle joints.
|
Fixed-bearing Ankle Prosthesis User
n=5 Participants
Users of the INBONE II Total Ankle Replacement fixed-bearing prosthesis.
Total Ankle Replacement Prosthesis: Comparison of functional range of motion in users of Stryker Scandinavian Total Ankle Replacement (STAR) prosthesis to users of INBONE 2 Total Ankle Replacement prosthesis and to matched controls with intact ankle joints.
|
|---|---|---|
|
Tibiotalar Joint Angle Kinematics
Dorsiflexion-Plantarflexion Angle
|
6.74 degrees
Standard Deviation 2.04
|
7.47 degrees
Standard Deviation 4.05
|
|
Tibiotalar Joint Angle Kinematics
Internal-External Rotation Angle
|
6.28 degrees
Standard Deviation 4.51
|
7.39 degrees
Standard Deviation 3.63
|
|
Tibiotalar Joint Angle Kinematics
Inversion-Eversion Angle
|
5.68 degrees
Standard Deviation 2.81
|
4.51 degrees
Standard Deviation 2.13
|
SECONDARY outcome
Timeframe: 1 yearPopulation: All participants who completed all aspects of the study protocol.
3D range of linear motions of the tibiotalar (upper ankle) joint were recorded and analyzed using a biplanar x-ray motion analysis system. In particular, linear joint ranges of motion were tested in terms of the anteroposterior, mediolateral, and superior-inferior axes.
Outcome measures
| Measure |
Mobile-bearing Ankle Prosthesis User
n=3 Participants
Users of the Stryker Scandinavian Total Ankle Replacement (STAR) mobile-bearing prosthesis.
Total Ankle Replacement Prosthesis: Comparison of functional range of motion in users of Stryker Scandinavian Total Ankle Replacement (STAR) prosthesis to users of INBONE 2 Total Ankle Replacement prosthesis and to matched controls with intact ankle joints.
|
Fixed-bearing Ankle Prosthesis User
n=5 Participants
Users of the INBONE II Total Ankle Replacement fixed-bearing prosthesis.
Total Ankle Replacement Prosthesis: Comparison of functional range of motion in users of Stryker Scandinavian Total Ankle Replacement (STAR) prosthesis to users of INBONE 2 Total Ankle Replacement prosthesis and to matched controls with intact ankle joints.
|
|---|---|---|
|
Tibiotalar Joint Linear Translation Kinematics
Superior-Inferior axis
|
0.28 mm
Standard Deviation 0.30
|
0.20 mm
Standard Deviation 0.13
|
|
Tibiotalar Joint Linear Translation Kinematics
Antero-posterior axis
|
0.68 mm
Standard Deviation 1.44
|
1.47 mm
Standard Deviation 2.07
|
|
Tibiotalar Joint Linear Translation Kinematics
Medio-Lateral axis
|
0.60 mm
Standard Deviation 1.41
|
1.13 mm
Standard Deviation 1.49
|
Adverse Events
Mobile-bearing Ankle Prosthesis User
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Fixed-bearing Ankle Prosthesis User
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