An observational study in Osteoarthritis, Knee, sponsored by 113th Hospital of Chinese People's Liberation Army. Completed at 1 site in China. Open to participants aged 50 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-01-22.
Sponsored by 113th Hospital of Chinese People's Liberation Army · Observational
This study aims to research on the association between the inclination of the proximal tibiofibular joint surface and medial compartment knee osteoarthritis. The proximal tibiofibular joint radiographs of the participants will be taken. The angle of inclination of the proximal tibiofibular joint surface in two groups will be compared.
The nonuniform settlement of the tibial plateau has been introduced to explain the development of knee varus and medial compartment knee osteoarthritis. It is believed that the lateral support of the fibula to the tibial plateau leads to the nonuniform settlement and degeneration of the plateau bilaterally.
Bone mass decreases as part of the normal aging process. Varying degrees of settlement of bone mass exist in the load-bearing joints, such as the knees, hips, ankles, and spine. In the proximal tibia, the lateral support of the fibula to the lateral tibial plateau routinely leads to nonuniform settlement, which is more severe in the medial plateau than in the lateral plateau. The slope of the tibial plateau arising from nonuniform settlement results in a transverse shearing force, with the femoral condyle shifting medially during walking and sports. Furthermore, side-slip aggravates the nonuniform settlement of the tibial plateau, especially in the medial plateau. Accordingly, a cycle of increasing the load distribution in the medial compartment and nonuniform settlement occurs. This results in the load from the normal distribution shifting farther medially to the medial plateau and consequently leads to knee varus, aggravating the progression of medial compartment knee osteoarthritis.
However, the angle of inclination of the proximal tibiofibular joint surface in different individuals varied widely. The angle of inclination of the proximal tibiofibular joint may affect the nonuniform settlement of the bilateral tibial plateau.
This study aims to research on the association between the inclination of the proximal tibiofibular joint surface and medial compartment knee osteoarthritis. A sample size power analysis was conducted before the study, which revealed that a minimum of 39 subjects per group was needed to achieve statistical significance with two-sided α=0.05 and 1-ß=0.80 and an assumed mean differences between two groups = 65% of the standard deviation.
Participants will be recruited from the outpatient clinic of No.113 Hospital of Chinese People's Liberation Army, as well as advertising flyers within the clinic. Firstly, patients of the study group will be recruited. It is hoped that the number of males will be equal to the number of females. Then the controls will be recruited and matched for age (within 5 years) and sex to the cases.
Standing anteroposterior knee radiographs and special PTFJ radiographs will be taken for the participants in both groups. The standing anteroposterior knee radiographs will be obtained with the knee extended. The PTFJ radiographs will be acquired with the knee of the participants in approximately 45°-60° of internal rotation.
On weight bearing anteroposterior radiographs of knee, osteoarthritis will be graded by using the Ahlbäck grading scale, and femorotibial angle will be measured. The Ahlbäck classification Stage 0: No radiographic sign of arthritis. Stage I: Narrowing of the joint space (JSN) (with or without subchondral sclerosis). JSN is defined by a space inferior to 3 mm, or inferior to the half of the space in the other compartment (or in the homologous compartment of the other knee). Stage II: Obliteration of the joint space; Stage III: Bone defect/loss \<5 mm. Stage IV: Bone defect/loss between 5 and 10 mm. Stage V: Bone defect/loss >10 mm, often with subluxation and arthritis of the other compartment.
For the PTFJ radiographs, the degenerative joint disease of the PTFJ will be staged with the Kellgren-Lawrence staging system, and the fibular inclination angle (FIA) and the tibial inclination angle (TIA) of the PTFJ surface to the longitudinal axis of both fibula and tibia will be measured separately. 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.
Demographics, laterality of included knees and FTA, the inclination angle of the proximal tibiofibular joint surface and the grade of the proximal tibiofibular joint degeneration in two groups will be evaluated and compared.
4,398 studies on the registry are indexed under Osteoarthritis; 582 are open to participants now.
This study's enrollment of 86 is below the median of 100 across 791 observational studies indexed under Osteoarthritis.
Browse Osteoarthritis studies →113th Hospital of Chinese People's Liberation Army is the lead sponsor of 2 studies on the registry; none are open to participants now.
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The outpatient clinic of No.113 Hospital of Chinese People's Liberation Army
Exclusion Criteria:
The participants with medial compartment knee osteoarthritis and without lateral compartment knee osteoarthritis according to the Ahlbäck classification.
Diagnostic Test: Standing anteroposterior knee radiographs and special proximal tibiofibular joint radiograph.
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.
Diagnostic Test: Standing anteroposterior knee radiographs and special proximal tibiofibular joint radiograph.
Standing anteroposterior knee radiographs and special proximal tibiofibular joint radiographs will be taken for the participants in both groups. The standing anteroposterior knee radiographs will be obtained with the knee extended. The proximal tibiofibular joint radiographs will be acquired with the knee of the participants in approximately 45°-60° of internal rotation.
The Fibular Inclination Angle of the Proximal Tibiofibular Joint Surface
The fibular inclination angle of the proximal tibiofibular joint surface to the longitudinal axes of both tibia and fibula
Time frame: 1 day
The Tibial Inclination Angle of the Proximal Tibiofibular Joint Surface
The tibial inclination angle of the proximal tibiofibular joint surface to the longitudinal axes of both tibia and fibula
Time frame: 1 day
Grade of the Proximal Tibiofibular Joint Degeneration
Arthritic 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.
Time frame: 1 day
The Femorotibial Angle
The lateral angle between the femoral axis and the tibial axis measured on an weight bearing anteroposterior radiograph of knee
Time frame: 1 day
The Fibular PTFJ Types
The 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°.
Time frame: 1 day
The Tibial PTFJ Types
The 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°.
Time frame: 1 day
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.
| Milestone | the Study Group | the Control Group |
|---|---|---|
| Started | 40 | 46 |
| Completed | 40 | 40 |
| Not completed | 0 | 6 |
| Withdrew: Physician decision | 0 | 6 |
The fibular inclination angle of the proximal tibiofibular joint surface to the longitudinal axes of both tibia and fibula
| degrees | the Study Group | the Control Group |
|---|---|---|
| The Fibular Inclination Angle of the Proximal Tibiofibular Joint Surface | 26.82 ± 7.97 | 31.99 ± 7.92 |
The tibial inclination angle of the proximal tibiofibular joint surface to the longitudinal axes of both tibia and fibula
| degrees | the Study Group | the Control Group |
|---|---|---|
| The Tibial Inclination Angle of the Proximal Tibiofibular Joint Surface | 26.91 ± 7.30 | 33.44 ± 6.85 |
Arthritic 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.
| Participants | the Study Group | the Control Group |
|---|---|---|
| grades 0 | 20 | 30 |
| grade Ⅰ | 14 | 8 |
| grade Ⅱ | 6 | 2 |
| grade Ⅲ | 0 | 0 |
| grade Ⅳ | 0 | 0 |
The lateral angle between the femoral axis and the tibial axis measured on an weight bearing anteroposterior radiograph of knee
| degrees | the Study Group | the Control Group |
|---|---|---|
| The Femorotibial Angle | 179.34 ± 3.60 | 174.37 ± 2.65 |
The 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°.
| Participants | the Study Group | the Control Group |
|---|---|---|
| horizontal type | 9 | 3 |
| oblique type | 31 | 37 |
The 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°.
| Participants | the Study Group | the Control Group |
|---|---|---|
| horizontal type | 8 | 2 |
| oblique type | 32 | 38 |
Collected over half an hour. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| the Study Group | 0/40 (0%) | 0/40 (0%) | 0/40 (0%) |
| the Control Group | 0/46 (0%) | 0/46 (0%) | 0/46 (0%) |
| Age, Continuous(years) | the Study Group | the Control Group | Total |
|---|---|---|---|
| Mean | 64.08 ± 6.84 | 61.10 ± 7.60 | 62.59 ± 7.34 |
| Sex: Female, Male(Participants) | the Study Group | the Control Group | Total |
|---|---|---|---|
| Female | 20 | 20 | 40 |
| Male | 20 | 20 | 40 |
| Race (NIH/OMB)(Participants) | the Study Group | the Control Group | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 40 | 40 | 80 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 |
| White | 0 | 0 | 0 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(participants) | the Study Group | the Control Group | Total |
|---|---|---|---|
| China | 40 | 40 | 80 |
| Body mass index(kg/m^2) | the Study Group | the Control Group | Total |
|---|---|---|---|
| Mean | 26.26 ± 3.72 | 24.84 ± 2.78 | 25.55 ± 3.34 |
| Laterality of knee(Participants) | the Study Group | the Control Group | Total |
|---|---|---|---|
| Right knee | 24 | 20 | 44 |
| Left knee | 16 | 20 | 36 |
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113th Hospital of Chinese People's Liberation Army