Trial Outcomes & Findings for Optimum Radiographic Assessment of the Knee (NCT NCT03685019)
NCT ID: NCT03685019
Last Updated: 2025-09-09
Results Overview
Knee minimum joint space width (medial and lateral compartment) measured using custom, validated, in house software (KneeMorph, MATLAB, MathWorks, Massachusetts).
TERMINATED
NA
8 participants
Day 0
2025-09-09
Participant Flow
Eight participants recruited with each undergoing treatment in each arm
Participant milestones
| Measure |
All Participants
All participants undergoing:
Valgus stress Varus stress 0 degree flexion medial compartment 0 degree flexion lateral compartment 20 degree flexion medial compartment 20 degree flexion lateral compartment 45 degree flexion medial compartment 45 degree flexion lateral compartment
|
|---|---|
|
Valgus Stress (Lateral Compartment)
STARTED
|
8
|
|
Valgus Stress (Lateral Compartment)
COMPLETED
|
8
|
|
Valgus Stress (Lateral Compartment)
NOT COMPLETED
|
0
|
|
Varus Stress (Medial Compartment)
STARTED
|
8
|
|
Varus Stress (Medial Compartment)
COMPLETED
|
8
|
|
Varus Stress (Medial Compartment)
NOT COMPLETED
|
0
|
|
0 Degrees Flexion (Medial Compartment)
STARTED
|
8
|
|
0 Degrees Flexion (Medial Compartment)
COMPLETED
|
8
|
|
0 Degrees Flexion (Medial Compartment)
NOT COMPLETED
|
0
|
|
0 Degrees Flexion (Lateral Compartment)
STARTED
|
8
|
|
0 Degrees Flexion (Lateral Compartment)
COMPLETED
|
8
|
|
0 Degrees Flexion (Lateral Compartment)
NOT COMPLETED
|
0
|
|
20 Degrees Flexion (Medial Compartment)
STARTED
|
8
|
|
20 Degrees Flexion (Medial Compartment)
COMPLETED
|
8
|
|
20 Degrees Flexion (Medial Compartment)
NOT COMPLETED
|
0
|
|
20 Degrees Flexion (Lateral Compartment)
STARTED
|
8
|
|
20 Degrees Flexion (Lateral Compartment)
COMPLETED
|
8
|
|
20 Degrees Flexion (Lateral Compartment)
NOT COMPLETED
|
0
|
|
45 Degrees Flexion (Medial Compartment)
STARTED
|
8
|
|
45 Degrees Flexion (Medial Compartment)
COMPLETED
|
8
|
|
45 Degrees Flexion (Medial Compartment)
NOT COMPLETED
|
0
|
|
45 Degrees Flexion (Lateral Compartment)
STARTED
|
8
|
|
45 Degrees Flexion (Lateral Compartment)
COMPLETED
|
8
|
|
45 Degrees Flexion (Lateral Compartment)
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
All Participants
n=8 Participants
All participants undergoing:
Valgus stress Varus stress 0 degree flexion medial compartment 0 degree flexion lateral compartment 20 degree flexion medial compartment 20 degree flexion lateral compartment 45 degree flexion medial compartment 45 degree flexion lateral compartment
|
|---|---|
|
Age, Continuous
|
70 years
n=8 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=8 Participants
|
|
Region of Enrollment
United Kingdom
|
8 participants
n=8 Participants
|
PRIMARY outcome
Timeframe: Day 0Population: Participants were recruited for the trial but due to poor recruitment and logistical challenges none of the participants underwent any of the proposed assessments and as such no outcome data was collected. The trial terminated due to poor recruitment.
Knee minimum joint space width (medial and lateral compartment) measured using custom, validated, in house software (KneeMorph, MATLAB, MathWorks, Massachusetts).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Day 0Population: Participants were recruited for the trial but due to poor recruitment and logistical challenges none of the participants underwent any of the proposed assessments and as such no outcome data was collected. The trial terminated due to poor recruitment.
The gold standard will be grade of arthritis at time of surgery in those patients undergoing knee replacement as part of their routine clinical care. Each compartment will be graded independently. An X-ray demonstrating a joint space width (JSW) of 0mm will be classified as full thickness cartilage loss, a JSW of \>0mm but \<4mm will be classified as partial thickness cartilage loss and a JSW of 4mm or greater will be classified as preserved full thickness cartilage. The sensitivity of each view at predicting the observed grade of cartilage disease within each compartment at the time of surgery will be recorded.
Outcome measures
Outcome data not reported
Adverse Events
Valgus Stress - Lateral Compartment
Varus Stress - Medial Compartment
0 Degree Flexion - Medial Compartment
0 Degree Flexion - Lateral Compartment
20 Degree Flexion - Medial Compartment
20 Degree Flexion - Lateral Compartment
45 Degree Flexion - Medial Compartment
45 Degree Flexion - Lateral Compartment
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