Trial Outcomes & Findings for Obesity and the Initiation of Knee Osteoarthritis (NCT NCT00856739)
NCT ID: NCT00856739
Last Updated: 2014-12-19
Results Overview
Recruitment status
COMPLETED
Target enrollment
177 participants
Primary outcome timeframe
baseline or first and only visit.
Results posted on
2014-12-19
Participant Flow
Participant milestones
| Measure |
Normal Weight
Body mass index between 18 and 25 kg/m\^2
|
Overweight
Body mass index between 25 and 30 kg/m\^2
|
Obese
Body mass index over 30 kg/m\^2
|
|---|---|---|---|
|
Overall Study
STARTED
|
70
|
52
|
55
|
|
Overall Study
COMPLETED
|
70
|
52
|
55
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Obesity and the Initiation of Knee Osteoarthritis
Baseline characteristics by cohort
| Measure |
Normal Weight
n=70 Participants
Body mass index between 18 and 25 kg/m\^2, no self-reported chronic pain or significant injury in any of the lower extremity joints or lower back
|
Overweight
n=52 Participants
Body mass index between 25 and 30 kg/m\^2, no self-reported chronic pain or significant injury in any of the lower extremity joints or lower back
|
Obese
n=55 Participants
Body mass index between 30 and 50 kg/m\^2, no self-reported chronic pain or significant injury in any of the lower extremity joints or lower back
|
Total
n=177 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
39.2 years
STANDARD_DEVIATION 11.99 • n=5 Participants
|
40.91 years
STANDARD_DEVIATION 13.08 • n=7 Participants
|
39.8 years
STANDARD_DEVIATION 11.27 • n=5 Participants
|
39.89 years
STANDARD_DEVIATION 12.06 • n=4 Participants
|
|
Sex: Female, Male
Female
|
40 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
90 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
30 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
87 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: baseline or first and only visit.Population: Obese were compared to healthy weight subjects. No overweight subjects were used in this analysis. Subjects were excluded based on MRI evidence of cartilage defects, osteophytes, ligament tears, meniscal tears, or bone marrow edema.
Outcome measures
| Measure |
Normal Weight
n=59 Participants
Body mass index between 18 and 25 kg/m\^2, no self-reported chronic pain or significant injury in any of the lower extremity joints or lower back
|
Obese
n=36 Participants
Body mass index between 30 and 50 kg/m\^2, no self-reported chronic pain or significant injury in any of the lower extremity joints or lower back
|
Normal Weight Middle Age
Body mass index between 18 and 25 kg/m\^2, age between 35 and 60
|
Overweight and Obese Middle Age
Body mass index between 27 and 50 kg/m\^2, age between 35 and 60
|
|---|---|---|---|---|
|
Gait Knee Adduction Moment
|
3.14 percent body weight (N)*height (m)
Standard Deviation 0.816
|
2.39 percent body weight (N)*height (m)
Standard Deviation 0.765
|
—
|
—
|
PRIMARY outcome
Timeframe: baseline or first and only visit.Population: Overweight and obese were combined based on similarities found in literature. Subjects were excluded based on MRI evidence of cartilage defects, osteophytes, ligament tears, meniscal tears, or bone marrow edema.
Medial/lateral thickness ratio
Outcome measures
| Measure |
Normal Weight
n=28 Participants
Body mass index between 18 and 25 kg/m\^2, no self-reported chronic pain or significant injury in any of the lower extremity joints or lower back
|
Obese
n=28 Participants
Body mass index between 30 and 50 kg/m\^2, no self-reported chronic pain or significant injury in any of the lower extremity joints or lower back
|
Normal Weight Middle Age
n=27 Participants
Body mass index between 18 and 25 kg/m\^2, age between 35 and 60
|
Overweight and Obese Middle Age
n=27 Participants
Body mass index between 27 and 50 kg/m\^2, age between 35 and 60
|
|---|---|---|---|---|
|
Cartilage Thickness
|
1.069 mm/mm
Standard Deviation 0.097
|
1.04571 mm/mm
Standard Deviation 0.169
|
1.051 mm/mm
Standard Deviation 0.127
|
1.069 mm/mm
Standard Deviation 0.139
|
Adverse Events
Normal Weight
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Overweight
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Obese
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
Dr. Thomas P. Andriacchi, Ph.D.
Stanford University, Palo Alto Veterans Hospital
Phone: 650-723-8024
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place