Trial Outcomes & Findings for THA Kinematics and Sound for Subjects Implanted Using Various Surgical Approaches (NCT NCT01833481)
NCT ID: NCT01833481
Last Updated: 2019-10-10
Results Overview
Determine amount of in vivo swing phase hip separation present within implanted hip during weight-bearing level walking while under fluoroscopic surveillance.
Recruitment status
COMPLETED
Target enrollment
30 participants
Primary outcome timeframe
6 months post-operatively
Results posted on
2019-10-10
Participant Flow
Participant milestones
| Measure |
THA Using Direct-anterior Surgical Approach
Patients will have undergone THA using a direct-anterior surgical approach and will undergo fluoroscopy surveillance while walking.
Fluoroscopy surveillance of patients while walking: While each subject performs a gait activity (normal walking) under fluoroscopic surveillance on a level treadmill, a data acquisition (DAQ) system will be used to determine the vibrations/sounds occurring during walking.
|
THA Using Anterior-lateral Approach
Patients will have undergone THA using an anterior-lateral surgical approach and will undergo fluoroscopy surveillance while walking.
Fluoroscopy surveillance of patients while walking: While each subject performs a gait activity (normal walking) under fluoroscopic surveillance on a level treadmill, a data acquisition (DAQ) system will be used to determine the vibrations/sounds occurring during walking.
|
THA Using Posterior-lateral Approach
Patients will have undergone THA using a posterior-lateral surgical approach and will undergo fluoroscopy surveillance while walking.
Fluoroscopy surveillance of patients while walking: While each subject performs a gait activity (normal walking) under fluoroscopic surveillance on a level treadmill, a data acquisition (DAQ) system will be used to determine the vibrations/sounds occurring during walking.
|
|---|---|---|---|
|
Overall Study
STARTED
|
10
|
10
|
10
|
|
Overall Study
COMPLETED
|
10
|
10
|
10
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
THA Kinematics and Sound for Subjects Implanted Using Various Surgical Approaches
Baseline characteristics by cohort
| Measure |
THA Using Direct-anterior Surgical Approach
n=10 Participants
Patients will have undergone THA using a direct-anterior surgical approach and will undergo fluoroscopy surveillance while walking.
Fluoroscopy surveillance of patients while walking: While each subject performs a gait activity (normal walking) under fluoroscopic surveillance on a level treadmill, a data acquisition (DAQ) system will be used to determine the vibrations/sounds occurring during walking.
|
THA Using Anterior-lateral Approach
n=10 Participants
Patients will have undergone THA using an anterior-lateral surgical approach and will undergo fluoroscopy surveillance while walking.
Fluoroscopy surveillance of patients while walking: While each subject performs a gait activity (normal walking) under fluoroscopic surveillance on a level treadmill, a data acquisition (DAQ) system will be used to determine the vibrations/sounds occurring during walking.
|
THA Using Posterior-lateral Approach
n=10 Participants
Patients will have undergone THA using a posterior-lateral surgical approach and will undergo fluoroscopy surveillance while walking.
Fluoroscopy surveillance of patients while walking: While each subject performs a gait activity (normal walking) under fluoroscopic surveillance on a level treadmill, a data acquisition (DAQ) system will be used to determine the vibrations/sounds occurring during walking.
|
Total
n=30 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
63 years
STANDARD_DEVIATION 7.3 • n=99 Participants
|
67 years
STANDARD_DEVIATION 5.4 • n=107 Participants
|
69 years
STANDARD_DEVIATION 8.7 • n=206 Participants
|
66 years
STANDARD_DEVIATION 7.4 • n=7 Participants
|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
6 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
12 Participants
n=7 Participants
|
|
Age, Categorical
>=65 years
|
4 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
18 Participants
n=7 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
18 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
12 Participants
n=7 Participants
|
|
Region of Enrollment
United States
|
10 participants
n=99 Participants
|
0 participants
n=107 Participants
|
10 participants
n=206 Participants
|
20 participants
n=7 Participants
|
|
Region of Enrollment
Canada
|
0 participants
n=99 Participants
|
10 participants
n=107 Participants
|
0 participants
n=206 Participants
|
10 participants
n=7 Participants
|
PRIMARY outcome
Timeframe: 6 months post-operativelyDetermine amount of in vivo swing phase hip separation present within implanted hip during weight-bearing level walking while under fluoroscopic surveillance.
Outcome measures
| Measure |
THA Using Direct-anterior Surgical Approach
n=10 Participants
Patients will have undergone THA using a direct-anterior surgical approach and will undergo fluoroscopy surveillance while walking.
Fluoroscopy surveillance of patients while walking: While each subject performs a gait activity (normal walking) under fluoroscopic surveillance on a level treadmill, a data acquisition (DAQ) system will be used to determine the vibrations/sounds occurring during walking.
|
THA Using Anterior-lateral Approach
n=10 Participants
Patients will have undergone THA using an anterior-lateral surgical approach and will undergo fluoroscopy surveillance while walking.
Fluoroscopy surveillance of patients while walking: While each subject performs a gait activity (normal walking) under fluoroscopic surveillance on a level treadmill, a data acquisition (DAQ) system will be used to determine the vibrations/sounds occurring during walking.
|
THA Using Posterior-lateral Approach
n=10 Participants
Patients will have undergone THA using a posterior-lateral surgical approach and will undergo fluoroscopy surveillance while walking.
Fluoroscopy surveillance of patients while walking: While each subject performs a gait activity (normal walking) under fluoroscopic surveillance on a level treadmill, a data acquisition (DAQ) system will be used to determine the vibrations/sounds occurring during walking.
|
|---|---|---|---|
|
Kinematics - Swing Phase Separation
|
0.9 mm
Standard Deviation 0.7
|
0.6 mm
Standard Deviation 0.3
|
1.0 mm
Standard Deviation 0.4
|
PRIMARY outcome
Timeframe: 6 months post-operativeDetermine amount of stance phase hip separation present in vivo of implanted hip during level walking activity under fluoroscopic surveillance.
Outcome measures
| Measure |
THA Using Direct-anterior Surgical Approach
n=10 Participants
Patients will have undergone THA using a direct-anterior surgical approach and will undergo fluoroscopy surveillance while walking.
Fluoroscopy surveillance of patients while walking: While each subject performs a gait activity (normal walking) under fluoroscopic surveillance on a level treadmill, a data acquisition (DAQ) system will be used to determine the vibrations/sounds occurring during walking.
|
THA Using Anterior-lateral Approach
n=10 Participants
Patients will have undergone THA using an anterior-lateral surgical approach and will undergo fluoroscopy surveillance while walking.
Fluoroscopy surveillance of patients while walking: While each subject performs a gait activity (normal walking) under fluoroscopic surveillance on a level treadmill, a data acquisition (DAQ) system will be used to determine the vibrations/sounds occurring during walking.
|
THA Using Posterior-lateral Approach
n=10 Participants
Patients will have undergone THA using a posterior-lateral surgical approach and will undergo fluoroscopy surveillance while walking.
Fluoroscopy surveillance of patients while walking: While each subject performs a gait activity (normal walking) under fluoroscopic surveillance on a level treadmill, a data acquisition (DAQ) system will be used to determine the vibrations/sounds occurring during walking.
|
|---|---|---|---|
|
Kinematics - Stance Phase Separation
|
0.9 mm
Standard Deviation 0.3
|
0.8 mm
Standard Deviation 0.6
|
1.0 mm
Standard Deviation 0.3
|
PRIMARY outcome
Timeframe: 6 months post-operativeDetermine overall hip separation present in vivo in implanted hip during level walking activity under fluoroscopic surveillance
Outcome measures
| Measure |
THA Using Direct-anterior Surgical Approach
n=10 Participants
Patients will have undergone THA using a direct-anterior surgical approach and will undergo fluoroscopy surveillance while walking.
Fluoroscopy surveillance of patients while walking: While each subject performs a gait activity (normal walking) under fluoroscopic surveillance on a level treadmill, a data acquisition (DAQ) system will be used to determine the vibrations/sounds occurring during walking.
|
THA Using Anterior-lateral Approach
n=10 Participants
Patients will have undergone THA using an anterior-lateral surgical approach and will undergo fluoroscopy surveillance while walking.
Fluoroscopy surveillance of patients while walking: While each subject performs a gait activity (normal walking) under fluoroscopic surveillance on a level treadmill, a data acquisition (DAQ) system will be used to determine the vibrations/sounds occurring during walking.
|
THA Using Posterior-lateral Approach
n=10 Participants
Patients will have undergone THA using a posterior-lateral surgical approach and will undergo fluoroscopy surveillance while walking.
Fluoroscopy surveillance of patients while walking: While each subject performs a gait activity (normal walking) under fluoroscopic surveillance on a level treadmill, a data acquisition (DAQ) system will be used to determine the vibrations/sounds occurring during walking.
|
|---|---|---|---|
|
Kinematics - Overall Separation
|
1.1 mm
Standard Deviation 0.6
|
0.8 mm
Standard Deviation 0.6
|
1.2 mm
Standard Deviation 0.4
|
Adverse Events
THA Using Direct-anterior Surgical Approach
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
THA Using Anterior-lateral Approach
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
THA Using Posterior-lateral Approach
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