Trial Outcomes & Findings for The Inclination of the Proximal Tibiofibular Joint Surface and Medial Compartment Knee Osteoarthritis (NCT NCT03147495)
NCT ID: NCT03147495
Last Updated: 2021-01-22
Results Overview
The fibular inclination angle of the proximal tibiofibular joint surface to the longitudinal axes of both tibia and fibula
Recruitment status
COMPLETED
Target enrollment
86 participants
Primary outcome timeframe
1 day
Results posted on
2021-01-22
Participant Flow
The participants were enrolled at the outpatient clinic of our hospital. The patients with medial compartment knee osteoarthritis were enrolled at first. The anticipated number of patients was 40, and the female-to-male ratio was expected to be 1:1. Then, the participants of the control group were enrolled and matched for sex and age (within 5 years) to the patients. The control-to-patient ratio was 1:1.
Participant milestones
| Measure |
the Study Group
The participants with medial compartment knee osteoarthritis and without lateral compartment knee osteoarthritis according to the Ahlbäck classification.
no intervention: The proximal tibiofibular joint radiographs will be taken for the participants in both groups.
|
the Control Group
The healthy volunteers without knee osteoarthritis according to the American College of Rheumatology criteria for the classification and reporting of OA of the knee joint. Radiographic evidence of the knee with Ahlbäck classification grade 0.
no intervention: The proximal tibiofibular joint radiographs will be taken for the participants in both groups.
|
|---|---|---|
|
Overall Study
STARTED
|
40
|
46
|
|
Overall Study
COMPLETED
|
40
|
40
|
|
Overall Study
NOT COMPLETED
|
0
|
6
|
Reasons for withdrawal
| Measure |
the Study Group
The participants with medial compartment knee osteoarthritis and without lateral compartment knee osteoarthritis according to the Ahlbäck classification.
no intervention: The proximal tibiofibular joint radiographs will be taken for the participants in both groups.
|
the Control Group
The healthy volunteers without knee osteoarthritis according to the American College of Rheumatology criteria for the classification and reporting of OA of the knee joint. Radiographic evidence of the knee with Ahlbäck classification grade 0.
no intervention: The proximal tibiofibular joint radiographs will be taken for the participants in both groups.
|
|---|---|---|
|
Overall Study
Physician Decision
|
0
|
6
|
Baseline Characteristics
The Inclination of the Proximal Tibiofibular Joint Surface and Medial Compartment Knee Osteoarthritis
Baseline characteristics by cohort
| Measure |
the Study Group
n=40 Participants
The participants with medial compartment knee osteoarthritis and without lateral compartment knee osteoarthritis according to the Ahlbäck classification.
no intervention: The proximal tibiofibular joint radiographs will be taken for the participants in both groups.
|
the Control Group
n=40 Participants
The healthy volunteers without knee osteoarthritis according to the American College of Rheumatology criteria for the classification and reporting of OA of the knee joint. Radiographic evidence of the knee with Ahlbäck classification grade 0.
no intervention: The proximal tibiofibular joint radiographs will be taken for the participants in both groups.
|
Total
n=80 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
64.08 years
STANDARD_DEVIATION 6.84 • n=5 Participants
|
61.10 years
STANDARD_DEVIATION 7.60 • n=7 Participants
|
62.59 years
STANDARD_DEVIATION 7.34 • n=5 Participants
|
|
Sex: Female, Male
Female
|
20 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
20 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
40 Participants
n=5 Participants
|
40 Participants
n=7 Participants
|
80 Participants
n=5 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
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
China
|
40 participants
n=5 Participants
|
40 participants
n=7 Participants
|
80 participants
n=5 Participants
|
|
Body mass index
|
26.26 kg/m^2
STANDARD_DEVIATION 3.72 • n=5 Participants
|
24.84 kg/m^2
STANDARD_DEVIATION 2.78 • n=7 Participants
|
25.55 kg/m^2
STANDARD_DEVIATION 3.34 • n=5 Participants
|
|
Laterality of knee
Right knee
|
24 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
44 Participants
n=5 Participants
|
|
Laterality of knee
Left knee
|
16 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 1 dayThe fibular inclination angle of the proximal tibiofibular joint surface to the longitudinal axes of both tibia and fibula
Outcome measures
| Measure |
the Study Group
n=40 Participants
The participants with medial compartment knee osteoarthritis and without lateral compartment knee osteoarthritis according to the Ahlbäck classification.
|
the Control Group
n=40 Participants
The healthy volunteers without knee osteoarthritis according to the American College of Rheumatology criteria for the classification and reporting of OA of the knee joint. Radiographic evidence of the knee with Ahlbäck classification grade 0.
|
|---|---|---|
|
The Fibular Inclination Angle of the Proximal Tibiofibular Joint Surface
|
26.82 degrees
Standard Deviation 7.97
|
31.99 degrees
Standard Deviation 7.92
|
PRIMARY outcome
Timeframe: 1 dayThe tibial inclination angle of the proximal tibiofibular joint surface to the longitudinal axes of both tibia and fibula
Outcome measures
| Measure |
the Study Group
n=40 Participants
The participants with medial compartment knee osteoarthritis and without lateral compartment knee osteoarthritis according to the Ahlbäck classification.
|
the Control Group
n=40 Participants
The healthy volunteers without knee osteoarthritis according to the American College of Rheumatology criteria for the classification and reporting of OA of the knee joint. Radiographic evidence of the knee with Ahlbäck classification grade 0.
|
|---|---|---|
|
The Tibial Inclination Angle of the Proximal Tibiofibular Joint Surface
|
26.91 degrees
Standard Deviation 7.30
|
33.44 degrees
Standard Deviation 6.85
|
SECONDARY outcome
Timeframe: 1 dayArthritic grades of the proximal tibiofibular joint were staged with Kellgren-Lawrence staging system. The Kellgren-Lawrence Grade 0: No X-ray changes of osteoarthritis. Grade I: Formation of osteophytes on the joint margins, in the knee joint, on the tibial spine. Grade II: Grade I + thinning of joint cartilage associated with sclerosis of subchondral bone. Grade III: Grade I + II + subchondral cysts. Grade IV: Grade I + II + III + deformation of the bone ends. The higher the Kellgren-Lawrence Grade is, the more severe the proximal tibiofibular joint degeneration.
Outcome measures
| Measure |
the Study Group
n=40 Participants
The participants with medial compartment knee osteoarthritis and without lateral compartment knee osteoarthritis according to the Ahlbäck classification.
|
the Control Group
n=40 Participants
The healthy volunteers without knee osteoarthritis according to the American College of Rheumatology criteria for the classification and reporting of OA of the knee joint. Radiographic evidence of the knee with Ahlbäck classification grade 0.
|
|---|---|---|
|
Grade of the Proximal Tibiofibular Joint Degeneration
grade Ⅳ
|
0 Participants
|
0 Participants
|
|
Grade of the Proximal Tibiofibular Joint Degeneration
grade Ⅰ
|
14 Participants
|
8 Participants
|
|
Grade of the Proximal Tibiofibular Joint Degeneration
grade Ⅱ
|
6 Participants
|
2 Participants
|
|
Grade of the Proximal Tibiofibular Joint Degeneration
grade Ⅲ
|
0 Participants
|
0 Participants
|
|
Grade of the Proximal Tibiofibular Joint Degeneration
grades 0
|
20 Participants
|
30 Participants
|
SECONDARY outcome
Timeframe: 1 dayThe lateral angle between the femoral axis and the tibial axis measured on an weight bearing anteroposterior radiograph of knee
Outcome measures
| Measure |
the Study Group
n=40 Participants
The participants with medial compartment knee osteoarthritis and without lateral compartment knee osteoarthritis according to the Ahlbäck classification.
|
the Control Group
n=40 Participants
The healthy volunteers without knee osteoarthritis according to the American College of Rheumatology criteria for the classification and reporting of OA of the knee joint. Radiographic evidence of the knee with Ahlbäck classification grade 0.
|
|---|---|---|
|
The Femorotibial Angle
|
179.34 degrees
Standard Deviation 3.60
|
174.37 degrees
Standard Deviation 2.65
|
SECONDARY outcome
Timeframe: 1 dayThe horizontal fibular PTFJ type was defined as the fibular inclination angle ≤ 20°, and the oblique fibular PTFJ type was defined as the fibular inclination angle \> 20°.
Outcome measures
| Measure |
the Study Group
n=40 Participants
The participants with medial compartment knee osteoarthritis and without lateral compartment knee osteoarthritis according to the Ahlbäck classification.
|
the Control Group
n=40 Participants
The healthy volunteers without knee osteoarthritis according to the American College of Rheumatology criteria for the classification and reporting of OA of the knee joint. Radiographic evidence of the knee with Ahlbäck classification grade 0.
|
|---|---|---|
|
The Fibular PTFJ Types
horizontal type
|
9 Participants
|
3 Participants
|
|
The Fibular PTFJ Types
oblique type
|
31 Participants
|
37 Participants
|
SECONDARY outcome
Timeframe: 1 dayThe horizontal tibial PTFJ type was defined as the tibial inclination angle ≤ 20°, and the oblique tibial PTFJ type was defined as the fibular inclination angle \> 20°.
Outcome measures
| Measure |
the Study Group
n=40 Participants
The participants with medial compartment knee osteoarthritis and without lateral compartment knee osteoarthritis according to the Ahlbäck classification.
|
the Control Group
n=40 Participants
The healthy volunteers without knee osteoarthritis according to the American College of Rheumatology criteria for the classification and reporting of OA of the knee joint. Radiographic evidence of the knee with Ahlbäck classification grade 0.
|
|---|---|---|
|
The Tibial PTFJ Types
horizontal type
|
8 Participants
|
2 Participants
|
|
The Tibial PTFJ Types
oblique type
|
32 Participants
|
38 Participants
|
Adverse Events
the Study Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
the Control Group
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. Cheng Huang
PLA Institute of Orthopaedics, Xijing Hospital, Fourth Military Medical University, No.17, Changle West Road, Xincheng District, Xi'an, Shanxi Province, China
Phone: 0086-57427754027
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place