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CompletedNCT03147495Updated Jan 22, 2021Results posted

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

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

Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
86
Ages
50 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Osteoarthritis, Knee
03

In context

Osteoarthritis

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 →

Lead sponsor

113th Hospital of Chinese People's Liberation Army is the lead sponsor of 2 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
50 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

The outpatient clinic of No.113 Hospital of Chinese People's Liberation Army

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

Exclusion Criteria:

  • any previous surgery or severe trauma in the affected limb.
  • inflammatory joint disease or tumors in the affected limb.
05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
86 participants (actual)
Patient registry
No

Groups and cohorts

  • the study group

    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 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.

    Diagnostic Test: Standing anteroposterior knee radiographs and special proximal tibiofibular joint radiograph.

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.

06

What researchers measure

Primary outcomes

  1. 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

  2. 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

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

07

Results

Posted Jan 22, 2021

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 flow — Overall Study
Milestonethe Study Groupthe Control Group
Started4046
Completed4040
Not completed06
Withdrew: Physician decision06

Outcome measures

PrimaryThe 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
Reported as:
Mean · degrees
The Fibular Inclination Angle of the Proximal Tibiofibular Joint Surface
degreesthe Study Groupthe Control Group
The Fibular Inclination Angle of the Proximal Tibiofibular Joint Surface26.82 ± 7.9731.99 ± 7.92
PrimaryThe 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
Reported as:
Mean · degrees
The Tibial Inclination Angle of the Proximal Tibiofibular Joint Surface
degreesthe Study Groupthe Control Group
The Tibial Inclination Angle of the Proximal Tibiofibular Joint Surface26.91 ± 7.3033.44 ± 6.85
SecondaryGrade 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
Reported as:
Count of participants · Participants
Grade of the Proximal Tibiofibular Joint Degeneration
Participantsthe Study Groupthe Control Group
grades 02030
grade Ⅰ148
grade Ⅱ62
grade Ⅲ00
grade Ⅳ00
SecondaryThe 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
Reported as:
Mean · degrees
The Femorotibial Angle
degreesthe Study Groupthe Control Group
The Femorotibial Angle179.34 ± 3.60174.37 ± 2.65
SecondaryThe 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
Reported as:
Count of participants · Participants
The Fibular PTFJ Types
Participantsthe Study Groupthe Control Group
horizontal type93
oblique type3137
SecondaryThe 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
Reported as:
Count of participants · Participants
The Tibial PTFJ Types
Participantsthe Study Groupthe Control Group
horizontal type82
oblique type3238

Adverse events

Collected over half an hour. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
the Study Group0/40 (0%)0/40 (0%)0/40 (0%)
the Control Group0/46 (0%)0/46 (0%)0/46 (0%)

Baseline characteristics

Age, Continuous
Age, Continuous(years)the Study Groupthe Control GroupTotal
Mean64.08 ± 6.8461.10 ± 7.6062.59 ± 7.34
Sex: Female, Male
Sex: Female, Male(Participants)the Study Groupthe Control GroupTotal
Female202040
Male202040
Race (NIH/OMB)
Race (NIH/OMB)(Participants)the Study Groupthe Control GroupTotal
American Indian or Alaska Native000
Asian404080
Native Hawaiian or Other Pacific Islander000
Black or African American000
White000
More than one race000
Unknown or Not Reported000
Region of Enrollment
Region of Enrollment(participants)the Study Groupthe Control GroupTotal
China404080
Body mass index
Body mass index(kg/m^2)the Study Groupthe Control GroupTotal
Mean26.26 ± 3.7224.84 ± 2.7825.55 ± 3.34
Laterality of knee
Laterality of knee(Participants)the Study Groupthe Control GroupTotal
Right knee242044
Left knee162036
08

Study locations

1 site
  • Orthopaedics clinic, No.113 Hospital of Chinese People's Liberation Army
    Ningbo, Zhejiang 315040, China
09

References and documents

Study documents

  • Protocol and statistical analysis plan · Feb 10, 2017

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 22, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT03147495
Lead sponsor
113th Hospital of Chinese People's Liberation Army
Collaborators
Air Force Military Medical University, China
Responsible party
Sponsor
First posted
May 10, 2017
Start date
Jul 27, 2017
Primary completion
Sep 13, 2020
Completion
Sep 13, 2020
Results posted
Jan 22, 2021
Last update
Jan 22, 2021

Study contacts

Qingsheng Zhu, MD
study director · Department of orthopaedics, Xijing hospital, Fourth Military Medical University, Xi'an, China

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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