Trial Outcomes & Findings for Imaging Biomarkers of Knee Osteoarthritis (NCT NCT02888119)
NCT ID: NCT02888119
Last Updated: 2022-12-27
Results Overview
MRI exam of accelerated 3D-T1p conducted on whole knee joint specimens to determine cartilage composition, measured as T1ρ relaxation time. T1ρ MRI relaxation times refer to the proteoglycan density within cartilage. Images taken at baseline and at Month 24.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
50 participants
Primary outcome timeframe
Baseline, Month 24
Results posted on
2022-12-27
Participant Flow
Participant milestones
| Measure |
High Risk for Osteoarthritis
"High risk of developing knee OA" has been defined by having knee pain but normal radiographs (Kellgren-Lawrence score 0 i.e. KL0) on both knees but at least one abnormal finding on clinical MR protocol such as overweight, prior knee injury (ligaments or menisci) or traumatic bone marrow edema lesions.
PRISMA 3T MRI scanner (Siemens Medical Solutions): A baseline MRI exam consisting of accelerated 3D-T1p, and T2, MRI will be performed. Longitudinal follow-up MRI exams (24 months) will be repeated on the same knee on all OA patients.
|
Mild Osteoarthritis
PRISMA 3T MRI scanner (Siemens Medical Solutions): A baseline MRI exam consisting of accelerated 3D-T1p, and T2, MRI will be performed. Longitudinal follow-up MRI exams (24 months) will be repeated on the same knee on all OA patients.
|
Healthy Controls
Controls will be age/gender matched to patients within 2 years of age.
PRISMA 3T MRI scanner (Siemens Medical Solutions): A baseline MRI exam consisting of accelerated 3D-T1p, and T2, MRI will be performed.
|
|---|---|---|---|
|
Overall Study
STARTED
|
11
|
7
|
30
|
|
Overall Study
COMPLETED
|
6
|
3
|
30
|
|
Overall Study
NOT COMPLETED
|
5
|
4
|
0
|
Reasons for withdrawal
| Measure |
High Risk for Osteoarthritis
"High risk of developing knee OA" has been defined by having knee pain but normal radiographs (Kellgren-Lawrence score 0 i.e. KL0) on both knees but at least one abnormal finding on clinical MR protocol such as overweight, prior knee injury (ligaments or menisci) or traumatic bone marrow edema lesions.
PRISMA 3T MRI scanner (Siemens Medical Solutions): A baseline MRI exam consisting of accelerated 3D-T1p, and T2, MRI will be performed. Longitudinal follow-up MRI exams (24 months) will be repeated on the same knee on all OA patients.
|
Mild Osteoarthritis
PRISMA 3T MRI scanner (Siemens Medical Solutions): A baseline MRI exam consisting of accelerated 3D-T1p, and T2, MRI will be performed. Longitudinal follow-up MRI exams (24 months) will be repeated on the same knee on all OA patients.
|
Healthy Controls
Controls will be age/gender matched to patients within 2 years of age.
PRISMA 3T MRI scanner (Siemens Medical Solutions): A baseline MRI exam consisting of accelerated 3D-T1p, and T2, MRI will be performed.
|
|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
5
|
4
|
0
|
Baseline Characteristics
Imaging Biomarkers of Knee Osteoarthritis
Baseline characteristics by cohort
| Measure |
High Risk for Osteoarthritis
n=6 Participants
"High risk of developing knee OA" has been defined by having knee pain but normal radiographs (Kellgren-Lawrence score 0 i.e. KL0) on both knees but at least one abnormal finding on clinical MR protocol such as overweight, prior knee injury (ligaments or menisci) or traumatic bone marrow edema lesions.
PRISMA 3T MRI scanner (Siemens Medical Solutions): A baseline MRI exam consisting of accelerated 3D-T1p, and T2, MRI will be performed. Longitudinal follow-up MRI exams (24 months) will be repeated on the same knee on all OA patients.
|
Mild Osteoarthritis
n=3 Participants
PRISMA 3T MRI scanner (Siemens Medical Solutions): A baseline MRI exam consisting of accelerated 3D-T1p, and T2, MRI will be performed. Longitudinal follow-up MRI exams (24 months) will be repeated on the same knee on all OA patients.
|
Healthy Controls
n=30 Participants
Controls will be age/gender matched to patients within 2 years of age.
PRISMA 3T MRI scanner (Siemens Medical Solutions): A baseline MRI exam consisting of accelerated 3D-T1p, and T2, MRI will be performed.
|
Total
n=39 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
62.3 years
STANDARD_DEVIATION 4.5 • n=5 Participants
|
64.7 years
STANDARD_DEVIATION 5.7 • n=7 Participants
|
57.9 years
STANDARD_DEVIATION 8.6 • n=5 Participants
|
59.1 years
STANDARD_DEVIATION 8.2 • n=4 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
21 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
18 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
26 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
16 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
6 participants
n=5 Participants
|
3 participants
n=7 Participants
|
30 participants
n=5 Participants
|
39 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline, Month 24MRI exam of accelerated 3D-T1p conducted on whole knee joint specimens to determine cartilage composition, measured as T1ρ relaxation time. T1ρ MRI relaxation times refer to the proteoglycan density within cartilage. Images taken at baseline and at Month 24.
Outcome measures
| Measure |
Mild Osteoarthritis
n=3 Participants
PRISMA 3T MRI scanner (Siemens Medical Solutions): A baseline MRI exam consisting of accelerated 3D-T1p, and T2, MRI will be performed. Longitudinal follow-up MRI exams (24 months) will be repeated on the same knee on all OA patients.
|
High Risk for Osteoarthritis
n=6 Participants
"High risk of developing knee OA" has been defined by having knee pain but normal radiographs (Kellgren-Lawrence score 0 i.e. KL0) on both knees but at least one abnormal finding on clinical MR protocol such as overweight, prior knee injury (ligaments or menisci) or traumatic bone marrow edema lesions.
PRISMA 3T MRI scanner (Siemens Medical Solutions): A baseline MRI exam consisting of accelerated 3D-T1p, and T2, MRI will be performed. Longitudinal follow-up MRI exams (24 months) will be repeated on the same knee on all OA patients.
|
|---|---|---|
|
Change From Baseline in T1ρ Relaxation Time
|
13.3 milliseconds
Standard Deviation 9.4
|
2.1 milliseconds
Standard Deviation 2.2
|
PRIMARY outcome
Timeframe: Baseline, Month 24MRI exam of accelerated T2 conducted on whole knee joint specimens to determine cartilage composition, measured as T2 relaxation time. T2 relaxation represents the time constant of the molecular motion of water in cartilage, which is influenced by the composition of collagen and specifically reflects changes to the extracellular matrix. Images taken at baseline and at Month 24.
Outcome measures
| Measure |
Mild Osteoarthritis
n=3 Participants
PRISMA 3T MRI scanner (Siemens Medical Solutions): A baseline MRI exam consisting of accelerated 3D-T1p, and T2, MRI will be performed. Longitudinal follow-up MRI exams (24 months) will be repeated on the same knee on all OA patients.
|
High Risk for Osteoarthritis
n=6 Participants
"High risk of developing knee OA" has been defined by having knee pain but normal radiographs (Kellgren-Lawrence score 0 i.e. KL0) on both knees but at least one abnormal finding on clinical MR protocol such as overweight, prior knee injury (ligaments or menisci) or traumatic bone marrow edema lesions.
PRISMA 3T MRI scanner (Siemens Medical Solutions): A baseline MRI exam consisting of accelerated 3D-T1p, and T2, MRI will be performed. Longitudinal follow-up MRI exams (24 months) will be repeated on the same knee on all OA patients.
|
|---|---|---|
|
Change From Baseline in T2 Relaxation Time
|
11 milliseconds
Standard Deviation 7.8
|
0.7 milliseconds
Standard Deviation 6.3
|
SECONDARY outcome
Timeframe: Baseline, Month 24The WOMAC is a 33-item self assessment of how participants feel about their knee and how well they can perform usual activities. The questionnaire contains 4 separately scored subscales - Symptoms; Stiffness; Pain and Function; and Daily Living. The total score is a percentage score from 0 to 100; lower scores represent less pain, less stiffness, and better physical function; higher scores indicate greater pain, greater stiffness, and worse physical function. A decrease in scores indicates participants' health improved during the observational period.
Outcome measures
| Measure |
Mild Osteoarthritis
n=3 Participants
PRISMA 3T MRI scanner (Siemens Medical Solutions): A baseline MRI exam consisting of accelerated 3D-T1p, and T2, MRI will be performed. Longitudinal follow-up MRI exams (24 months) will be repeated on the same knee on all OA patients.
|
High Risk for Osteoarthritis
n=6 Participants
"High risk of developing knee OA" has been defined by having knee pain but normal radiographs (Kellgren-Lawrence score 0 i.e. KL0) on both knees but at least one abnormal finding on clinical MR protocol such as overweight, prior knee injury (ligaments or menisci) or traumatic bone marrow edema lesions.
PRISMA 3T MRI scanner (Siemens Medical Solutions): A baseline MRI exam consisting of accelerated 3D-T1p, and T2, MRI will be performed. Longitudinal follow-up MRI exams (24 months) will be repeated on the same knee on all OA patients.
|
|---|---|---|
|
Change From Baseline in Western Ontario and McMaster University OA Index (WOMAC) Score
|
2.5 score on a scale
Standard Deviation 4.1
|
5.4 score on a scale
Standard Deviation 8.6
|
SECONDARY outcome
Timeframe: Baseline, Month 24Knee-specific instrument, developed to assess patients' opinion about their knee and associated problems. The KOOS evaluates both short-term and long-term consequences of knee injury. It holds 42 items in 5 separately scored subscales - Pain; Other Symptoms; Function in daily living (ADL); Function in Sport and Recreation (Sport/Rec); and knee-related Quality of Life (QOL). The total score is a percentage score from 0 to 100; 0 represents extreme problems and 100 represents no problems. An increase in scores indicates participants' health improved during the observational period.
Outcome measures
| Measure |
Mild Osteoarthritis
n=3 Participants
PRISMA 3T MRI scanner (Siemens Medical Solutions): A baseline MRI exam consisting of accelerated 3D-T1p, and T2, MRI will be performed. Longitudinal follow-up MRI exams (24 months) will be repeated on the same knee on all OA patients.
|
High Risk for Osteoarthritis
n=6 Participants
"High risk of developing knee OA" has been defined by having knee pain but normal radiographs (Kellgren-Lawrence score 0 i.e. KL0) on both knees but at least one abnormal finding on clinical MR protocol such as overweight, prior knee injury (ligaments or menisci) or traumatic bone marrow edema lesions.
PRISMA 3T MRI scanner (Siemens Medical Solutions): A baseline MRI exam consisting of accelerated 3D-T1p, and T2, MRI will be performed. Longitudinal follow-up MRI exams (24 months) will be repeated on the same knee on all OA patients.
|
|---|---|---|
|
Change From Baseline in Knee Injury and OA Outcomes Score (KOOS)
|
6.2 score on a scale
Standard Deviation 4.5
|
6 score on a scale
Standard Deviation 11.9
|
SECONDARY outcome
Timeframe: Baseline, 24 MonthsSelf-assessment of multiple domains of activity in older adults. Questions evaluate both occupational and non-occupational knee bending, squatting and stair climbing. Total scores range from 0 to 400 or above and are quantified based on frequency values and weights for these activities. Higher scores indicate higher levels of physical activity. An increase in scores indicates physical activity increased during the observational period.
Outcome measures
| Measure |
Mild Osteoarthritis
n=3 Participants
PRISMA 3T MRI scanner (Siemens Medical Solutions): A baseline MRI exam consisting of accelerated 3D-T1p, and T2, MRI will be performed. Longitudinal follow-up MRI exams (24 months) will be repeated on the same knee on all OA patients.
|
High Risk for Osteoarthritis
n=6 Participants
"High risk of developing knee OA" has been defined by having knee pain but normal radiographs (Kellgren-Lawrence score 0 i.e. KL0) on both knees but at least one abnormal finding on clinical MR protocol such as overweight, prior knee injury (ligaments or menisci) or traumatic bone marrow edema lesions.
PRISMA 3T MRI scanner (Siemens Medical Solutions): A baseline MRI exam consisting of accelerated 3D-T1p, and T2, MRI will be performed. Longitudinal follow-up MRI exams (24 months) will be repeated on the same knee on all OA patients.
|
|---|---|---|
|
Change From Baseline in Physical Activity Scale for the Elderly (PASE) Scores
|
3.2 score on a scale
Standard Deviation 4.5
|
3.8 score on a scale
Standard Deviation 10.1
|
Adverse Events
High Risk for Osteoarthritis
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Mild Osteoarthritis
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Healthy Controls
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