Osteoarthritis, KneeNCT03147495
The Inclination of the Proximal Tibiofibular Joint Surface and Medial Compartment Knee Osteoarthritis
An observational study of Osteoarthritis, Knee, run by 113th Hospital of Chinese People's Liberation Army at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Osteoarthritis, Knee
- What is being tested?
- Standing anteroposterior knee radiographs and special proximal tibiofibular joint radiograph.
- How many people
- 86 participants
- Where
- 1 siteChina
- Study dates
- 27 Jul 2017to 13 Sep 2020
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The outpatient clinic of No.113 Hospital of Chinese People's Liberation Army
Who may be able to join
- 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.
Who cannot join
- any previous surgery or severe trauma in the affected limb.
- inflammatory joint disease or tumors in the affected limb.
Trial locations and contacts
1 site in 1 country.
China1 site
Orthopaedics clinic, No.113 Hospital of Chinese People's Liberation Army
Ningbo, Zhejiang, 315040
About this study
Official title: Research on the Association Between the Inclination of the Proximal Tibiofibular Joint Surface and Medial Compartment Knee Osteoarthritis
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.
- Conditions
- Osteoarthritis, Knee
- Being tested
- Standing anteroposterior knee radiographs and special proximal tibiofibular joint radiograph.
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standing anteroposterior knee radiographs and special proximal tibiofibular joint radiograph.Diagnostic test
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.
| Study group | Role | What they receive |
|---|---|---|
| the study group | The participants with medial compartment knee osteoarthritis and without lateral compartment knee osteoarthritis according to the Ahlbäck classification. Receives: 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. Receives: Diagnostic Test: Standing anteroposterior knee radiographs and special proximal tibiofibular joint radiograph. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 1 day
Secondary outcomes (4)
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.
Measured: 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
Measured: 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°.
Measured: 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°.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2017
- Study start27 Jul 2017
- Primary completion13 Sep 2020
- Study completion13 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Osteoarthritis, KneeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- 113th Hospital of Chinese People's Liberation Army
- Sponsor type
- University, hospital or other
- Collaborators
- Air Force Military Medical University, China
- Responsible party
- Sponsor
- Investigators
- Qingsheng Zhu, MD, Study director, Department of orthopaedics, Xijing hospital, Fourth Military Medical University, Xi'an, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03147495
- Sponsor's protocol ID
- 113YY-LUNLI-2017005
- Status last verified
- Jan 2021
- First submitted
- 7 May 2017
- Last updated
- 22 Jan 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Research on the Association Between the Inclination of the Proximal Tibiofibular Joint Surface and Medial Compartment Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT03147495
- Acronym / sponsor ID
- 113YY-LUNLI-2017005
- Conditions
- Osteoarthritis, Knee
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- 113th Hospital of Chinese People's Liberation ArmyUniversity, hospital or other
- Collaborators
- Air Force Military Medical University, China
- Study start
- 27 Jul 2017 (actual)
- Primary completion
- 13 Sep 2020 (actual)
- Study completion
- 13 Sep 2020 (actual)
- First posted
- 10 May 2017 (actual)
- Results
- Posted 22 Jan 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| the study group | – | Diagnostic Test: Standing anteroposterior knee radiographs and special proximal tibiofibular joint radiograph.The participants with medial compartment knee osteoarthritis and without lateral compartment knee osteoarthritis according to the Ahlbäck classification. |
| the control group | – | 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. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The outpatient clinic of No.113 Hospital of Chinese People's Liberation Army
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (2 listed)
- any previous surgery or severe trauma in the affected limb.
- inflammatory joint disease or tumors in the affected limb.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Diagnostic test | the control group, the study group |
Primary outcome
The Fibular Inclination Angle of the Proximal Tibiofibular Joint Surface
Time frame: 1 day
The 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 Surface
Time frame: 1 day
The tibial inclination angle of the proximal tibiofibular joint surface to the longitudinal axes of both tibia and fibula
4 secondary outcomes
Grade of the Proximal Tibiofibular Joint Degeneration
Time frame: 1 day
The Femorotibial Angle
Time frame: 1 day
The Fibular PTFJ Types
Time frame: 1 day
The Tibial PTFJ Types
Time frame: 1 day
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Qingsheng Zhu, MD study director
Department of orthopaedics, Xijing hospital, Fourth Military Medical University, Xi'an, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Osteoarthritis, Knee, run by 113th Hospital of Chinese People's Liberation Army at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 22 Jan 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Fibular Inclination Angle of the Proximal Tibiofibular Joint Surface (time frame: 1 day). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2021.