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The Inclination of the Proximal Tibiofibular Joint Surface and Medial Compartment Knee Osteoarthritis

Research on the Association Between the Inclination of the Proximal Tibiofibular Joint Surface and Medial Compartment Knee Osteoarthritis

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03147495
Enrollment
86
Registered
2017-05-10
Start date
2017-07-27
Completion date
2020-09-13
Last updated
2021-01-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteoarthritis, Knee

Brief summary

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.

Detailed description

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.

Interventions

DIAGNOSTIC_TESTStanding 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.

Sponsors

Air Force Military Medical University, China
CollaboratorOTHER
113th Hospital of Chinese People's Liberation Army
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* symptomatic knee osteoarthritis according to the American College of Rheumatology criteria for the classification and reporting of OA of the knee joint, * predominance of self-reported pain over the medial aspect of the knee, * radiographic evidence of medial compartment knee osteoarthritis with an Ahlbäck score of grade I or greater, * and radiographic evidence of lateral compartment with Ahlbäck classification grade 0.

Exclusion criteria

* any previous surgery or severe trauma in the affected limb. * inflammatory joint disease or tumors in the affected limb.

Design outcomes

Primary

MeasureTime frameDescription
The Fibular Inclination Angle of the Proximal Tibiofibular Joint Surface1 dayThe fibular inclination angle of the proximal tibiofibular joint surface to the longitudinal axes of both tibia and fibula
The Tibial Inclination Angle of the Proximal Tibiofibular Joint Surface1 dayThe tibial inclination angle of the proximal tibiofibular joint surface to the longitudinal axes of both tibia and fibula

Secondary

MeasureTime frameDescription
Grade of the Proximal Tibiofibular Joint Degeneration1 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.
The Femorotibial Angle1 dayThe lateral angle between the femoral axis and the tibial axis measured on an weight bearing anteroposterior radiograph of knee
The Fibular PTFJ Types1 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°.
The Tibial PTFJ Types1 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°.

Countries

China

Participant flow

Recruitment details

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.

Participants by arm

ArmCount
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.
40
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.
40
Total80

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyPhysician Decision06

Baseline characteristics

CharacteristicTotalthe Study Groupthe Control Group
Age, Continuous62.59 years
STANDARD_DEVIATION 7.34
64.08 years
STANDARD_DEVIATION 6.84
61.10 years
STANDARD_DEVIATION 7.6
Body mass index25.55 kg/m^2
STANDARD_DEVIATION 3.34
26.26 kg/m^2
STANDARD_DEVIATION 3.72
24.84 kg/m^2
STANDARD_DEVIATION 2.78
Laterality of knee
Left knee
36 Participants16 Participants20 Participants
Laterality of knee
Right knee
44 Participants24 Participants20 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
80 Participants40 Participants40 Participants
Race (NIH/OMB)
Black or African American
0 Participants0 Participants0 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
White
0 Participants0 Participants0 Participants
Region of Enrollment
China
80 participants40 participants40 participants
Sex: Female, Male
Female
40 Participants20 Participants20 Participants
Sex: Female, Male
Male
40 Participants20 Participants20 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 400 / 46
other
Total, other adverse events
0 / 400 / 46
serious
Total, serious adverse events
0 / 400 / 46

Outcome results

Primary

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

ArmMeasureValue (MEAN)Dispersion
the Study GroupThe Fibular Inclination Angle of the Proximal Tibiofibular Joint Surface26.82 degreesStandard Deviation 7.97
the Control GroupThe Fibular Inclination Angle of the Proximal Tibiofibular Joint Surface31.99 degreesStandard Deviation 7.92
Primary

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

ArmMeasureValue (MEAN)Dispersion
the Study GroupThe Tibial Inclination Angle of the Proximal Tibiofibular Joint Surface26.91 degreesStandard Deviation 7.3
the Control GroupThe Tibial Inclination Angle of the Proximal Tibiofibular Joint Surface33.44 degreesStandard Deviation 6.85
Secondary

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

ArmMeasureCategoryValue (COUNT_OF_PARTICIPANTS)
the Study GroupGrade of the Proximal Tibiofibular Joint Degenerationgrade Ⅰ14 Participants
the Study GroupGrade of the Proximal Tibiofibular Joint Degenerationgrade Ⅲ0 Participants
the Study GroupGrade of the Proximal Tibiofibular Joint Degenerationgrade Ⅱ6 Participants
the Study GroupGrade of the Proximal Tibiofibular Joint Degenerationgrade Ⅳ0 Participants
the Study GroupGrade of the Proximal Tibiofibular Joint Degenerationgrades 020 Participants
the Control GroupGrade of the Proximal Tibiofibular Joint Degenerationgrade Ⅳ0 Participants
the Control GroupGrade of the Proximal Tibiofibular Joint Degenerationgrades 030 Participants
the Control GroupGrade of the Proximal Tibiofibular Joint Degenerationgrade Ⅰ8 Participants
the Control GroupGrade of the Proximal Tibiofibular Joint Degenerationgrade Ⅱ2 Participants
the Control GroupGrade of the Proximal Tibiofibular Joint Degenerationgrade Ⅲ0 Participants
Secondary

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

ArmMeasureValue (MEAN)Dispersion
the Study GroupThe Femorotibial Angle179.34 degreesStandard Deviation 3.6
the Control GroupThe Femorotibial Angle174.37 degreesStandard Deviation 2.65
Secondary

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

ArmMeasureCategoryValue (COUNT_OF_PARTICIPANTS)
the Study GroupThe Fibular PTFJ Typeshorizontal type9 Participants
the Study GroupThe Fibular PTFJ Typesoblique type31 Participants
the Control GroupThe Fibular PTFJ Typeshorizontal type3 Participants
the Control GroupThe Fibular PTFJ Typesoblique type37 Participants
Secondary

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

ArmMeasureCategoryValue (COUNT_OF_PARTICIPANTS)
the Study GroupThe Tibial PTFJ Typesoblique type32 Participants
the Study GroupThe Tibial PTFJ Typeshorizontal type8 Participants
the Control GroupThe Tibial PTFJ Typesoblique type38 Participants
the Control GroupThe Tibial PTFJ Typeshorizontal type2 Participants

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026