Trial Outcomes & Findings for Validation of a Stress Device for the Knee (NCT NCT02444663)
NCT ID: NCT02444663
Last Updated: 2021-11-04
Results Overview
Knee minimum joint space width measured on anteroposterior fluoroscopic images using custom, validated, in house software (KneeMorph, MATLAB, MathWorks, Massachusetts).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
9 participants
Primary outcome timeframe
Day 0
Results posted on
2021-11-04
Participant Flow
In total 9 participants recruited with the interventions in each arm applied to all participants
Participant milestones
| Measure |
All Study Participants
All study participants Clinician Valgus Clinician Varus Device Valgus 0N Device Valgus 10N Device Valgus 20N Device Valgus 30N Device Varus 0N Device Varus 10N Device Varus 20N Device Varus 30N
|
|---|---|
|
Clinician Valgus
STARTED
|
9
|
|
Clinician Valgus
COMPLETED
|
9
|
|
Clinician Valgus
NOT COMPLETED
|
0
|
|
Clinician Varus
STARTED
|
9
|
|
Clinician Varus
COMPLETED
|
9
|
|
Clinician Varus
NOT COMPLETED
|
0
|
|
Device Valgus 0N
STARTED
|
9
|
|
Device Valgus 0N
COMPLETED
|
9
|
|
Device Valgus 0N
NOT COMPLETED
|
0
|
|
Device Valgus 10N
STARTED
|
9
|
|
Device Valgus 10N
COMPLETED
|
9
|
|
Device Valgus 10N
NOT COMPLETED
|
0
|
|
Device Valgus 20N
STARTED
|
9
|
|
Device Valgus 20N
COMPLETED
|
9
|
|
Device Valgus 20N
NOT COMPLETED
|
0
|
|
Device Valgus 30N
STARTED
|
9
|
|
Device Valgus 30N
COMPLETED
|
9
|
|
Device Valgus 30N
NOT COMPLETED
|
0
|
|
Device Varus 0N
STARTED
|
9
|
|
Device Varus 0N
COMPLETED
|
9
|
|
Device Varus 0N
NOT COMPLETED
|
0
|
|
Device Varus 10N
STARTED
|
9
|
|
Device Varus 10N
COMPLETED
|
9
|
|
Device Varus 10N
NOT COMPLETED
|
0
|
|
Device Varus 20N
STARTED
|
9
|
|
Device Varus 20N
COMPLETED
|
9
|
|
Device Varus 20N
NOT COMPLETED
|
0
|
|
Device Varus 30N
STARTED
|
9
|
|
Device Varus 30N
COMPLETED
|
9
|
|
Device Varus 30N
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Validation of a Stress Device for the Knee
Baseline characteristics by cohort
| Measure |
All Participants
n=9 Participants
All participants
|
|---|---|
|
Age, Continuous
|
70 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United Kingdom
|
9 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 0Knee minimum joint space width measured on anteroposterior fluoroscopic images using custom, validated, in house software (KneeMorph, MATLAB, MathWorks, Massachusetts).
Outcome measures
| Measure |
Clinician Valgus
n=9 Participants
Clinician performed fluoroscopic valgus and varus stress X-rays
Clinician Valgus: Clinician performed valgus stress X-ray under fluoroscopy
|
Clinician Varus
n=9 Participants
Clinician performed fluoroscopic varus stress X-rays
Clinician Varus: Clinician performed varus stress X-ray under fluoroscopy
|
Device Valgus - 0 Newton Force
n=9 Participants
Device performed fluoroscopic valgus stress X-rays - 0 Newton force
Device Valgus - 0 Newton: Device (Oxford Stress System for Knee Arthroplasty Radiographs (OSSKAR)) performed valgus stress X-ray under fluoroscopy.
|
Device Valgus - 10 Newton Force
n=9 Participants
Device performed fluoroscopic valgus stress X-rays - 10 Newton force
Device Valgus - 10 Newton: Device (Oxford Stress System for Knee Arthroplasty Radiographs (OSSKAR)) performed varus stress X-ray under fluoroscopy.
|
Device Valgus - 20 Newton Force
n=9 Participants
Device performed fluoroscopic valgus stress X-rays - 20 Newton force
Device Valgus - 20 Newton: Device (Oxford Stress System for Knee Arthroplasty Radiographs (OSSKAR)) performed valgus stress X-ray under fluoroscopy.
|
Device Valgus - 30 Newton Force
n=9 Participants
Device performed fluoroscopic valgus stress X-rays - 30 Newton force
Device Valgus - 30 Newton: Device (Oxford Stress System for Knee Arthroplasty Radiographs (OSSKAR)) performed valgus stress X-ray under fluoroscopy.
|
Device Varus - 0 Newton Force
n=9 Participants
Device performed fluoroscopic varus stress X-rays - 0 Newton force
Device Varus - 0 Newton: Device (Oxford Stress System for Knee Arthroplasty Radiographs (OSSKAR)) performed valgus stress X-ray under fluoroscopy.
|
Device Varus - 10 Newton Force
n=9 Participants
Device performed fluoroscopic varus stress X-rays - 10 Newton force
Device Varus - 10 Newton: Device (Oxford Stress System for Knee Arthroplasty Radiographs (OSSKAR)) performed valgus stress X-ray under fluoroscopy.
|
Device Varus - 20 Newton Force
n=9 Participants
Device performed fluoroscopic varus stress X-rays - 20 Newton force
Device Varus - 20 Newton: Device (Oxford Stress System for Knee Arthroplasty Radiographs (OSSKAR)) performed valgus stress X-ray under fluoroscopy.
|
Device Varus - 30 Newton Force
n=9 Participants
Device performed fluoroscopic varus stress X-rays - 30 Newton force
Device Varus - 30 Newton: Device (Oxford Stress System for Knee Arthroplasty Radiographs (OSSKAR)) performed valgus stress X-ray under fluoroscopy.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Compartment Specific Knee Minimum Joint Space Width (Varus - Medial Compartment, Valgus - Lateral Compartment)
|
7.42 mm
Standard Deviation 1.38
|
3.92 mm
Standard Deviation 2.12
|
8.22 mm
Standard Deviation 1.3
|
7.47 mm
Standard Deviation 1.54
|
7.31 mm
Standard Deviation 1.71
|
7.33 mm
Standard Deviation 1.62
|
8.56 mm
Standard Deviation 1.44
|
4.41 mm
Standard Deviation 1.83
|
3.7 mm
Standard Deviation 2.08
|
3.84 mm
Standard Deviation 2.28
|
SECONDARY outcome
Timeframe: At time of procedurePain Score during stress radiographs (VAS 0 - 10) where a higher score represents more pain (10 = worst pain).
Outcome measures
| Measure |
Clinician Valgus
n=9 Participants
Clinician performed fluoroscopic valgus and varus stress X-rays
Clinician Valgus: Clinician performed valgus stress X-ray under fluoroscopy
|
Clinician Varus
n=9 Participants
Clinician performed fluoroscopic varus stress X-rays
Clinician Varus: Clinician performed varus stress X-ray under fluoroscopy
|
Device Valgus - 0 Newton Force
n=9 Participants
Device performed fluoroscopic valgus stress X-rays - 0 Newton force
Device Valgus - 0 Newton: Device (Oxford Stress System for Knee Arthroplasty Radiographs (OSSKAR)) performed valgus stress X-ray under fluoroscopy.
|
Device Valgus - 10 Newton Force
n=9 Participants
Device performed fluoroscopic valgus stress X-rays - 10 Newton force
Device Valgus - 10 Newton: Device (Oxford Stress System for Knee Arthroplasty Radiographs (OSSKAR)) performed varus stress X-ray under fluoroscopy.
|
Device Valgus - 20 Newton Force
n=9 Participants
Device performed fluoroscopic valgus stress X-rays - 20 Newton force
Device Valgus - 20 Newton: Device (Oxford Stress System for Knee Arthroplasty Radiographs (OSSKAR)) performed valgus stress X-ray under fluoroscopy.
|
Device Valgus - 30 Newton Force
n=9 Participants
Device performed fluoroscopic valgus stress X-rays - 30 Newton force
Device Valgus - 30 Newton: Device (Oxford Stress System for Knee Arthroplasty Radiographs (OSSKAR)) performed valgus stress X-ray under fluoroscopy.
|
Device Varus - 0 Newton Force
n=9 Participants
Device performed fluoroscopic varus stress X-rays - 0 Newton force
Device Varus - 0 Newton: Device (Oxford Stress System for Knee Arthroplasty Radiographs (OSSKAR)) performed valgus stress X-ray under fluoroscopy.
|
Device Varus - 10 Newton Force
n=9 Participants
Device performed fluoroscopic varus stress X-rays - 10 Newton force
Device Varus - 10 Newton: Device (Oxford Stress System for Knee Arthroplasty Radiographs (OSSKAR)) performed valgus stress X-ray under fluoroscopy.
|
Device Varus - 20 Newton Force
n=9 Participants
Device performed fluoroscopic varus stress X-rays - 20 Newton force
Device Varus - 20 Newton: Device (Oxford Stress System for Knee Arthroplasty Radiographs (OSSKAR)) performed valgus stress X-ray under fluoroscopy.
|
Device Varus - 30 Newton Force
n=9 Participants
Device performed fluoroscopic varus stress X-rays - 30 Newton force
Device Varus - 30 Newton: Device (Oxford Stress System for Knee Arthroplasty Radiographs (OSSKAR)) performed valgus stress X-ray under fluoroscopy.
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Pain (VAS 0 - 10)
|
3.67 units on a scale
Standard Deviation 2.08
|
4.00 units on a scale
Standard Deviation 2.00
|
0 units on a scale
Standard Deviation 0
|
0.78 units on a scale
Standard Deviation 0.74
|
1.56 units on a scale
Standard Deviation 2.35
|
5.44 units on a scale
Standard Deviation 2.01
|
0 units on a scale
Standard Deviation 0
|
0.88 units on a scale
Standard Deviation 1.64
|
1.25 units on a scale
Standard Deviation 2.31
|
4.88 units on a scale
Standard Deviation 1.36
|
Adverse Events
Clinician Valgus
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Clinician Varus
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Device Valgus - 0 Newton Force
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Device Valgus - 10 Newton Force
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Device Valgus - 20 Newton Force
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Device Valgus - 30 Newton Force
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Device Varus - 0 Newton Force
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Device Varus - 10 Newton Force
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Device Varus - 20 Newton Force
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Device Varus - 30 Newton Force
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
Thomas Hamilton, Clinical Research Fellow
University of Oxford
Phone: 01865227696
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place