Osteoarthritis,KneeNCT03011112
Can 3D Kinematic Parameters Assess the Symptomatic and Functional Severity of KOA?
An observational study of Osteoarthritis,Knee, run by Guangzhou General Hospital of Guangzhou Military Command at 1 site in China.
Trial summary
There is little study focusing on kinematic parameters in the assessment of the symptomatic and functional severity of knee osteoarthritis (KOA). The purpose of this study is to evaluate the correlations between kinematic parameters and the severity of symptoms and functions in patients with KOA. Read more about this study
- Who is it for?
- Ages 50 to 90 years
- Conditions the study is for
- Osteoarthritis,Knee
- What is being tested?
- Observational procedure
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 186 participants
- Where
- 1 siteChina
- Study dates
- 2 Jan 2017to 28 Feb 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All the patients diagnosed with KOA will be recruited via hospital advertisements in this study.
Who may be able to join
- age> 50 years
- body mass index<30;
- confirmed radiographically and assessed according to KL score;
- knee pain in their knees at least three months;
- absolute medial compartment KOA according to atlas criteria13;
- able to walk unaided
Who cannot join
- history of knee surgery;
- Corticosteroid or Sodium Hyaluronate injection within 6 months;
- neuropathic arthropathy or rheumatoid arthritis;
- any other muscular or neurological diseases that affected the condition of the lower limbs;
- any treatments or training (e.g. kneepad) to improve the symptoms of KOA;
- history of foot/ankle/hip injury or disease;
Show all 12Show fewer
- unable to walk independently;
- history of heart disease;
- lateral KOA according to atlas criteria13;
- body mass index> 30;
- age> 90 years;
- unable to finish the procedure
Trial locations and contacts
1 site in 1 country.
China1 site
Hospital of Orthopedics, Guangzhou General Hospital of Guangzhou Military Command
Guangzhou, Guangdong, 510010
About this study
Official title: Can Three Dimensional Kinematic Parameters Assess the Symptomatic and Functional Severity of Medial Knee Osteoarthritis?
There is little study focusing on kinematic parameters in the assessment of the symptomatic and functional severity of knee osteoarthritis (KOA). The purpose of this study is to evaluate the correlations between kinematic parameters and the severity of symptoms and functions in patients with KOA.
- Conditions
- Osteoarthritis,Knee
- Being tested
- Observational procedure
- Keywords
- Osteoarthritis, Knee, WOMAC, gait, kinematics
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Observational procedureProcedure or surgery
All the patients will undergo a standard observational procedure: i) diagnosed with KOA; ii) take a radiographic examination (x-ray); iii) assessed by WOMAC; iv) take an physical examination to avoid other disease; iv) take a gait examination on a treadmill in barefoot.
| Study group | Role | What they receive |
|---|---|---|
| KL 1 | All patients (>50 years) are classified to be Kellgrence/Lawrence grade 1 according to Kellgrence/Lawrence score. Receives: Procedure: Observational procedure | |
| KL 2 | All patients (>50 years) are classified to be Kellgrence/Lawrence grade 2 according to Kellgrence/Lawrence score. Receives: Procedure: Observational procedure | |
| KL 3 | All patients (>50 years) are classified to be Kellgrence/Lawrence grade 3 according to Kellgrence/Lawrence score. Receives: Procedure: Observational procedure | |
| KL 4 | All patients (>50 years) are classified to be Kellgrence/Lawrence grade 4 according to Kellgrence/Lawrence score. Receives: Procedure: Observational procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Knee flexion/extension angle at initial contact during gait.
The gait cycle include seven key events (e.g. initial contact), and each gait has six degrees of freedom, including knee flexion/extension, internal/external rotation, adduction/abduction, anterior/posterior translation, distal/proximal translation, medial/lateral translation. The unit of angle is degree and that of translation is millimetre.
Measured: 1 Day
Knee internal/external rotation angle at initial contact during gait.
The gait cycle include seven key events (e.g. initial contact), and each gait has six degrees of freedom, including knee flexion/extension, internal/external rotation, adduction/abduction, anterior/posterior translation, distal/proximal translation, medial/lateral translation. The unit of angle is degree and that of translation is millimetre.
Measured: 1 Day
Knee adduction/abduction angle at initial contact during gait.
The gait cycle include seven key events (e.g. initial contact), and each gait has six degrees of freedom, including knee flexion/extension, internal/external rotation, adduction/abduction, anterior/posterior translation, distal/proximal translation, medial/lateral translation. The unit of angle is degree and that of translation is millimetre.
Measured: 1 Day
knee anterior/posterior translation at initial contact during gait.
The gait cycle include seven key events (e.g. initial contact), and each gait has six degrees of freedom, including knee flexion/extension, internal/external rotation, adduction/abduction, anterior/posterior translation, distal/proximal translation, medial/lateral translation. The unit of angle is degree and that of translation is millimetre.
Measured: 1 Day
Knee medial/lateral translation at initial contact during gait.
The gait cycle include seven key events (e.g. initial contact), and each gait has six degrees of freedom, including knee flexion/extension, internal/external rotation, adduction/abduction, anterior/posterior translation, distal/proximal translation, medial/lateral translation. The unit of angle is degree and that of translation is millimetre.
Measured: 1 Day
Knee proximal/distal translation at initial contact during gait.
The gait cycle include seven key events (e.g. initial contact), and each gait has six degrees of freedom, including knee flexion/extension, internal/external rotation, adduction/abduction, anterior/posterior translation, distal/proximal translation, medial/lateral translation. The unit of angle is degree and that of translation is millimetre.
Measured: 1 Day
WOMAC
The Western Ontario and McMaster Universities Osteoarthritis Index
Measured: 1 Day
Kellgren/Lawrence Score
Measured: 1 Day
Knee flexion/extension angle at opposite toe off during gait.
The gait cycle include seven key events (e.g. initial contact), and each gait has six degrees of freedom, including knee flexion/extension, internal/external rotation, adduction/abduction, anterior/posterior translation, distal/proximal translation, medial/lateral translation. The unit of angle is degree and that of translation is millimetre.
Measured: 1 Day
Knee internal/external rotation angle at opposite toe off during gait.
The gait cycle include seven key events (e.g. initial contact), and each gait has six degrees of freedom, including knee flexion/extension, internal/external rotation, adduction/abduction, anterior/posterior translation, distal/proximal translation, medial/lateral translation. The unit of angle is degree and that of translation is millimetre.
Measured: 1 Day
Knee adduction/abduction angle at opposite toe off during gait.
The gait cycle include seven key events (e.g. initial contact), and each gait has six degrees of freedom, including knee flexion/extension, internal/external rotation, adduction/abduction, anterior/posterior translation, distal/proximal translation, medial/lateral translation. The unit of angle is degree and that of translation is millimetre.
Measured: 1 Day
Knee anterior/posterior translation at opposite toe off during gait.
The gait cycle include seven key events (e.g. initial contact), and each gait has six degrees of freedom, including knee flexion/extension, internal/external rotation, adduction/abduction, anterior/posterior translation, distal/proximal translation, medial/lateral translation. The unit of angle is degree and that of translation is millimetre.
Measured: 1 Day
Knee distal/proximal translation at opposite toe off during gait.
Measured: 1 Day
Knee medial/lateral translation at opposite toe off during gait.
The gait cycle include seven key events (e.g. initial contact), and each gait has six degrees of freedom, including knee flexion/extension, internal/external rotation, adduction/abduction, anterior/posterior translation, distal/proximal translation, medial/lateral translation. The unit of angle is degree and that of translation is millimetre.
Measured: 1 Day
Knee flexion/extension angle at heel rise during gait.
The gait cycle include seven key events (e.g. initial contact), and each gait has six degrees of freedom, including knee flexion/extension, internal/external rotation, adduction/abduction, anterior/posterior translation, distal/proximal translation, medial/lateral translation. The unit of angle is degree and that of translation is millimetre.
Measured: 1 Day
Knee internal/external rotation angle at heel rise during gait.
The gait cycle include seven key events (e.g. initial contact), and each gait has six degrees of freedom, including knee flexion/extension, internal/external rotation, adduction/abduction, anterior/posterior translation, distal/proximal translation, medial/lateral translation. The unit of angle is degree and that of translation is millimetre.
Measured: 1 Day
Knee adduction/abduction angle at heel rise during gait.
The gait cycle include seven key events (e.g. initial contact), and each gait has six degrees of freedom, including knee flexion/extension, internal/external rotation, adduction/abduction, anterior/posterior translation, distal/proximal translation, medial/lateral translation. The unit of angle is degree and that of translation is millimetre.
Measured: 1 Day
Knee anterior/posterior translation at heel rise during gait.
The gait cycle include seven key events (e.g. initial contact), and each gait has six degrees of freedom, including knee flexion/extension, internal/external rotation, adduction/abduction, anterior/posterior translation, distal/proximal translation, medial/lateral translation. The unit of angle is degree and that of translation is millimetre.
Measured: 1 Day
Knee distal/proximal translation at heel rise during gait.
The gait cycle include seven key events (e.g. initial contact), and each gait has six degrees of freedom, including knee flexion/extension, internal/external rotation, adduction/abduction, anterior/posterior translation, distal/proximal translation, medial/lateral translation. The unit of angle is degree and that of translation is millimetre.
Measured: 1 Day
Knee medial/lateral translation at heel rise during gait.
The gait cycle include seven key events (e.g. initial contact), and each gait has six degrees of freedom, including knee flexion/extension, internal/external rotation, adduction/abduction, anterior/posterior translation, distal/proximal translation, medial/lateral translation. The unit of angle is degree and that of translation is millimetre.
Measured: 1 Day
Knee flexion/extension angle at opposite initial contact during gait.
The gait cycle include seven key events (e.g. initial contact), and each gait has six degrees of freedom, including knee flexion/extension, internal/external rotation, adduction/abduction, anterior/posterior translation, distal/proximal translation, medial/lateral translation. The unit of angle is degree and that of translation is millimetre.
Measured: 1 Day
Knee internal/external angle at opposite initial contact during gait.
The gait cycle include seven key events (e.g. initial contact), and each gait has six degrees of freedom, including knee flexion/extension, internal/external rotation, adduction/abduction, anterior/posterior translation, distal/proximal translation, medial/lateral translation. The unit of angle is degree and that of translation is millimetre.
Measured: 1 Day
Knee adduction/abduction angle at opposite initial contact during gait.
The gait cycle include seven key events (e.g. initial contact), and each gait has six degrees of freedom, including knee flexion/extension, internal/external rotation, adduction/abduction, anterior/posterior translation, distal/proximal translation, medial/lateral translation. The unit of angle is degree and that of translation is millimetre.
Measured: 1 Day
Knee anterior/posterior translation at opposite initial contact during gait.
The gait cycle include seven key events (e.g. initial contact), and each gait has six degrees of freedom, including knee flexion/extension, internal/external rotation, adduction/abduction, anterior/posterior translation, distal/proximal translation, medial/lateral translation. The unit of angle is degree and that of translation is millimetre.
Measured: 1 Day
Knee distal/proximal translation at opposite initial contact during gait.
The gait cycle include seven key events (e.g. initial contact), and each gait has six degrees of freedom, including knee flexion/extension, internal/external rotation, adduction/abduction, anterior/posterior translation, distal/proximal translation, medial/lateral translation. The unit of angle is degree and that of translation is millimetre.
Measured: 1 Day
Knee medial/lateral translation at opposite initial contact during gait.
The gait cycle include seven key events (e.g. initial contact), and each gait has six degrees of freedom, including knee flexion/extension, internal/external rotation, adduction/abduction, anterior/posterior translation, distal/proximal translation, medial/lateral translation. The unit of angle is degree and that of translation is millimetre.
Measured: 1 Day
Knee flexion/extension angle at toe off during gait.
The gait cycle include seven key events (e.g. initial contact), and each gait has six degrees of freedom, including knee flexion/extension, internal/external rotation, adduction/abduction, anterior/posterior translation, distal/proximal translation, medial/lateral translation. The unit of angle is degree and that of translation is millimetre.
Measured: 1 Day
Knee adduction/abduction angle at toe off during gait.
The gait cycle include seven key events (e.g. initial contact), and each gait has six degrees of freedom, including knee flexion/extension, internal/external rotation, adduction/abduction, anterior/posterior translation, distal/proximal translation, medial/lateral translation. The unit of angle is degree and that of translation is millimetre.
Measured: 1 Day
Knee internal/external rotation angle at toe off during gait.
The gait cycle include seven key events (e.g. initial contact), and each gait has six degrees of freedom, including knee flexion/extension, internal/external rotation, adduction/abduction, anterior/posterior translation, distal/proximal translation, medial/lateral translation. The unit of angle is degree and that of translation is millimetre.
Measured: 1 Day
Knee anterior/posterior translation at toe off during gait.
The gait cycle include seven key events (e.g. initial contact), and each gait has six degrees of freedom, including knee flexion/extension, internal/external rotation, adduction/abduction, anterior/posterior translation, distal/proximal translation, medial/lateral translation. The unit of angle is degree and that of translation is millimetre.
Measured: 1 Day
Knee distal/proximal translation at toe off during gait.
The gait cycle include seven key events (e.g. initial contact), and each gait has six degrees of freedom, including knee flexion/extension, internal/external rotation, adduction/abduction, anterior/posterior translation, distal/proximal translation, medial/lateral translation. The unit of angle is degree and that of translation is millimetre.
Measured: 1 Day
Knee medial/lateral translation at toe off during gait.
The gait cycle include seven key events (e.g. initial contact), and each gait has six degrees of freedom, including knee flexion/extension, internal/external rotation, adduction/abduction, anterior/posterior translation, distal/proximal translation, medial/lateral translation. The unit of angle is degree and that of translation is millimetre.
Measured: 1 Day
Knee flexion/extension angle at feet adjacent during gait.
The gait cycle include seven key events (e.g. initial contact), and each gait has six degrees of freedom, including knee flexion/extension, internal/external rotation, adduction/abduction, anterior/posterior translation, distal/proximal translation, medial/lateral translation. The unit of angle is degree and that of translation is millimetre.
Measured: 1 Day
Knee internal/external rotation angle at feet adjacent during gait.
The gait cycle include seven key events (e.g. initial contact), and each gait has six degrees of freedom, including knee flexion/extension, internal/external rotation, adduction/abduction, anterior/posterior translation, distal/proximal translation, medial/lateral translation. The unit of angle is degree and that of translation is millimetre.
Measured: 1 Day
Knee adduction/abduction angle at feet adjacent during gait.
The gait cycle include seven key events (e.g. initial contact), and each gait has six degrees of freedom, including knee flexion/extension, internal/external rotation, adduction/abduction, anterior/posterior translation, distal/proximal translation, medial/lateral translation. The unit of angle is degree and that of translation is millimetre.
Measured: 1 Day
Knee anterior/posterior translation at feet adjacent during gait.
The gait cycle include seven key events (e.g. initial contact), and each gait has six degrees of freedom, including knee flexion/extension, internal/external rotation, adduction/abduction, anterior/posterior translation, distal/proximal translation, medial/lateral translation. The unit of angle is degree and that of translation is millimetre.
Measured: 1 Day
Knee distal/proximal translation at feet adjacent during gait.
The gait cycle include seven key events (e.g. initial contact), and each gait has six degrees of freedom, including knee flexion/extension, internal/external rotation, adduction/abduction, anterior/posterior translation, distal/proximal translation, medial/lateral translation. The unit of angle is degree and that of translation is millimetre.
Measured: 1 Day
Knee medial/lateral translation at feet adjacent during gait.
The gait cycle include seven key events (e.g. initial contact), and each gait has six degrees of freedom, including knee flexion/extension, internal/external rotation, adduction/abduction, anterior/posterior translation, distal/proximal translation, medial/lateral translation. The unit of angle is degree and that of translation is millimetre.
Measured: 1 Day
Knee flexion/extension angle at tibia vertical during gait.
The gait cycle include seven key events (e.g. initial contact), and each gait has six degrees of freedom, including knee flexion/extension, internal/external rotation, adduction/abduction, anterior/posterior translation, distal/proximal translation, medial/lateral translation. The unit of angle is degree and that of translation is millimetre.
Measured: 1 Day
Knee adduction/abduction angle at tibia vertical during gait.
The gait cycle include seven key events (e.g. initial contact), and each gait has six degrees of freedom, including knee flexion/extension, internal/external rotation, adduction/abduction, anterior/posterior translation, distal/proximal translation, medial/lateral translation. The unit of angle is degree and that of translation is millimetre.
Measured: 1 Day
Knee internal/external rotation angle at tibia vertical during gait.
The gait cycle include seven key events (e.g. initial contact), and each gait has six degrees of freedom, including knee flexion/extension, internal/external rotation, adduction/abduction, anterior/posterior translation, distal/proximal translation, medial/lateral translation. The unit of angle is degree and that of translation is millimetre.
Measured: 1 Day
Knee anterior/posterior translation at tibia vertical during gait.
The gait cycle include seven key events (e.g. initial contact), and each gait has six degrees of freedom, including knee flexion/extension, internal/external rotation, adduction/abduction, anterior/posterior translation, distal/proximal translation, medial/lateral translation. The unit of angle is degree and that of translation is millimetre.
Measured: 1 Day
Knee distal/proximal translation at tibia vertical during gait.
The gait cycle include seven key events (e.g. initial contact), and each gait has six degrees of freedom, including knee flexion/extension, internal/external rotation, adduction/abduction, anterior/posterior translation, distal/proximal translation, medial/lateral translation. The unit of angle is degree and that of translation is millimetre.
Measured: 1 Day
Knee medial/lateral translation at tibia vertical during gait.
The gait cycle include seven key events (e.g. initial contact), and each gait has six degrees of freedom, including knee flexion/extension, internal/external rotation, adduction/abduction, anterior/posterior translation, distal/proximal translation, medial/lateral translation. The unit of angle is degree and that of translation is millimetre.
Measured: 1 Day
Range of motion of knee flexion/extension angle.
The gait cycle include seven key events (e.g. initial contact), and each gait has six degrees of freedom, including knee flexion/extension, internal/external rotation, adduction/abduction, anterior/posterior translation, distal/proximal translation, medial/lateral translation. The unit of angle is degree and that of translation is millimetre.
Measured: 1 Day
Range of motion of knee internal/external rotation angle.
The gait cycle include seven key events (e.g. initial contact), and each gait has six degrees of freedom, including knee flexion/extension, internal/external rotation, adduction/abduction, anterior/posterior translation, distal/proximal translation, medial/lateral translation. The unit of angle is degree and that of translation is millimetre.
Measured: 1 Day
Range of motion of knee adduction/abduction angle.
The gait cycle include seven key events (e.g. initial contact), and each gait has six degrees of freedom, including knee flexion/extension, internal/external rotation, adduction/abduction, anterior/posterior translation, distal/proximal translation, medial/lateral translation. The unit of angle is degree and that of translation is millimetre.
Measured: 1 Day
Range of motion of knee anterior/posterior translation.
The gait cycle include seven key events (e.g. initial contact), and each gait has six degrees of freedom, including knee flexion/extension, internal/external rotation, adduction/abduction, anterior/posterior translation, distal/proximal translation, medial/lateral translation. The unit of angle is degree and that of translation is millimetre.
Measured: 1 Day
Range of motion of knee distal/proximal translation.
The gait cycle include seven key events (e.g. initial contact), and each gait has six degrees of freedom, including knee flexion/extension, internal/external rotation, adduction/abduction, anterior/posterior translation, distal/proximal translation, medial/lateral translation. The unit of angle is degree and that of translation is millimetre.
Measured: 1 Day
Range of motion of knee medial/lateral translation.
The gait cycle include seven key events (e.g. initial contact), and each gait has six degrees of freedom, including knee flexion/extension, internal/external rotation, adduction/abduction, anterior/posterior translation, distal/proximal translation, medial/lateral translation. The unit of angle is degree and that of translation is millimetre.
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 posted5 Jan 2017 (estimated)
- Study start2 Jan 2017
- Primary completion20 Feb 2017
- Study completion28 Feb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Cross-sectional
- Enrolment
- 186 participants (actual)
Sponsor and investigators
- Lead sponsor
- Guangzhou General Hospital of Guangzhou Military Command
- Sponsor type
- University, hospital or other
- Collaborators
- Medical Center of Assessment, Prevention and Treatment of Bone & Joint Diseases, Guangdong, China, The First Affiliated Hospital of Guangzhou Medical University
- Responsible party
- Principal investigator, Yu Zhang, Guangzhou General Hospital of Guangzhou Military Command
- Investigators
- Yu Zhang, PhD, Principal investigator, Hospital of Orthopedics, Guangzhou General Hospital of Guangzhou Military Command, 111 Liuhua Road, Guangzhou 510010, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03011112
- Sponsor's protocol ID
- GuangzhouGH003
- Status last verified
- Mar 2017
- First submitted
- 3 Jan 2017
- Last updated
- 3 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can Three Dimensional Kinematic Parameters Assess the Symptomatic and Functional Severity of Medial Knee Osteoarthritis?
- ClinicalTrials.gov ID
- NCT03011112
- Acronym / sponsor ID
- GuangzhouGH003
- Conditions
- Osteoarthritis,Knee
- Keywords
- Osteoarthritis, Knee, WOMAC, gait, kinematics
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 186 participants (actual)
- Lead sponsor
- Guangzhou General Hospital of Guangzhou Military CommandUniversity, hospital or other
- Collaborators
- Medical Center of Assessment, Prevention and Treatment of Bone & Joint Diseases, Guangdong, China, The First Affiliated Hospital of Guangzhou Medical University
- Study start
- 2 Jan 2017 (actual)
- Primary completion
- 20 Feb 2017 (actual)
- Study completion
- 28 Feb 2017 (actual)
- First posted
- 5 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
There is little study focusing on kinematic parameters in the assessment of the symptomatic and functional severity of knee osteoarthritis (KOA). The purpose of this study is to evaluate the correlations between kinematic parameters and the severity of symptoms and functions in patients with KOA.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| KL 1 | – | Procedure: Observational procedureAll patients (>50 years) are classified to be Kellgrence/Lawrence grade 1 according to Kellgrence/Lawrence score. |
| KL 2 | – | Procedure: Observational procedureAll patients (>50 years) are classified to be Kellgrence/Lawrence grade 2 according to Kellgrence/Lawrence score. |
| KL 3 | – | Procedure: Observational procedureAll patients (>50 years) are classified to be Kellgrence/Lawrence grade 3 according to Kellgrence/Lawrence score. |
| KL 4 | – | Procedure: Observational procedureAll patients (>50 years) are classified to be Kellgrence/Lawrence grade 4 according to Kellgrence/Lawrence score. |
Who may qualify
- Ages
- 50 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All the patients diagnosed with KOA will be recruited via hospital advertisements in this study.
Key inclusion criteria (6 listed)
- age> 50 years
- body mass index<30;
- confirmed radiographically and assessed according to KL score;
- knee pain in their knees at least three months;
- absolute medial compartment KOA according to atlas criteria13;
Key exclusion criteria (12 listed)
- history of knee surgery;
- Corticosteroid or Sodium Hyaluronate injection within 6 months;
- neuropathic arthropathy or rheumatoid arthritis;
- any other muscular or neurological diseases that affected the condition of the lower limbs;
- any treatments or training (e.g. kneepad) to improve the symptoms of KOA;
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 |
|---|---|---|
| Observational procedureAll the patients will undergo a standard observational procedure: i) diagnosed with KOA; ii) take a radiographic examination (x-ray); iii) assessed by WOMAC; iv) take an physical examination to avoid other disease; iv) take a gait examination on a treadmill in barefoot. | Procedure or surgery | KL 1, KL 2, KL 3, KL 4 |
Primary outcome
Knee flexion/extension angle at initial contact during gait.
Time frame: 1 Day
The gait cycle include seven key events (e.g. initial contact), and each gait has six degrees of freedom, including knee flexion/extension, internal/external rotation, adduction/abduction, anterior/posterior translation, distal/proximal translation, medial/lateral translation. The unit of angle is degree and that of translation is millimetre.
Knee internal/external rotation angle at initial contact during gait.
Time frame: 1 Day
The gait cycle include seven key events (e.g. initial contact), and each gait has six degrees of freedom, including knee flexion/extension, internal/external rotation, adduction/abduction, anterior/posterior translation, distal/proximal translation, medial/lateral translation. The unit of angle is degree and that of translation is millimetre.
Knee adduction/abduction angle at initial contact during gait.
Time frame: 1 Day
The gait cycle include seven key events (e.g. initial contact), and each gait has six degrees of freedom, including knee flexion/extension, internal/external rotation, adduction/abduction, anterior/posterior translation, distal/proximal translation, medial/lateral translation. The unit of angle is degree and that of translation is millimetre.
knee anterior/posterior translation at initial contact during gait.
Time frame: 1 Day
The gait cycle include seven key events (e.g. initial contact), and each gait has six degrees of freedom, including knee flexion/extension, internal/external rotation, adduction/abduction, anterior/posterior translation, distal/proximal translation, medial/lateral translation. The unit of angle is degree and that of translation is millimetre.
Knee medial/lateral translation at initial contact during gait.
Time frame: 1 Day
The gait cycle include seven key events (e.g. initial contact), and each gait has six degrees of freedom, including knee flexion/extension, internal/external rotation, adduction/abduction, anterior/posterior translation, distal/proximal translation, medial/lateral translation. The unit of angle is degree and that of translation is millimetre.
Knee proximal/distal translation at initial contact during gait.
Time frame: 1 Day
The gait cycle include seven key events (e.g. initial contact), and each gait has six degrees of freedom, including knee flexion/extension, internal/external rotation, adduction/abduction, anterior/posterior translation, distal/proximal translation, medial/lateral translation. The unit of angle is degree and that of translation is millimetre.
WOMAC
Time frame: 1 Day
The Western Ontario and McMaster Universities Osteoarthritis Index
Kellgren/Lawrence Score
Time frame: 1 Day
Knee flexion/extension angle at opposite toe off during gait.
Time frame: 1 Day
The gait cycle include seven key events (e.g. initial contact), and each gait has six degrees of freedom, including knee flexion/extension, internal/external rotation, adduction/abduction, anterior/posterior translation, distal/proximal translation, medial/lateral translation. The unit of angle is degree and that of translation is millimetre.
Knee internal/external rotation angle at opposite toe off during gait.
Time frame: 1 Day
The gait cycle include seven key events (e.g. initial contact), and each gait has six degrees of freedom, including knee flexion/extension, internal/external rotation, adduction/abduction, anterior/posterior translation, distal/proximal translation, medial/lateral translation. The unit of angle is degree and that of translation is millimetre.
Knee adduction/abduction angle at opposite toe off during gait.
Time frame: 1 Day
The gait cycle include seven key events (e.g. initial contact), and each gait has six degrees of freedom, including knee flexion/extension, internal/external rotation, adduction/abduction, anterior/posterior translation, distal/proximal translation, medial/lateral translation. The unit of angle is degree and that of translation is millimetre.
Knee anterior/posterior translation at opposite toe off during gait.
Time frame: 1 Day
The gait cycle include seven key events (e.g. initial contact), and each gait has six degrees of freedom, including knee flexion/extension, internal/external rotation, adduction/abduction, anterior/posterior translation, distal/proximal translation, medial/lateral translation. The unit of angle is degree and that of translation is millimetre.
Knee distal/proximal translation at opposite toe off during gait.
Time frame: 1 Day
Knee medial/lateral translation at opposite toe off during gait.
Time frame: 1 Day
The gait cycle include seven key events (e.g. initial contact), and each gait has six degrees of freedom, including knee flexion/extension, internal/external rotation, adduction/abduction, anterior/posterior translation, distal/proximal translation, medial/lateral translation. The unit of angle is degree and that of translation is millimetre.
Knee flexion/extension angle at heel rise during gait.
Time frame: 1 Day
The gait cycle include seven key events (e.g. initial contact), and each gait has six degrees of freedom, including knee flexion/extension, internal/external rotation, adduction/abduction, anterior/posterior translation, distal/proximal translation, medial/lateral translation. The unit of angle is degree and that of translation is millimetre.
Knee internal/external rotation angle at heel rise during gait.
Time frame: 1 Day
The gait cycle include seven key events (e.g. initial contact), and each gait has six degrees of freedom, including knee flexion/extension, internal/external rotation, adduction/abduction, anterior/posterior translation, distal/proximal translation, medial/lateral translation. The unit of angle is degree and that of translation is millimetre.
Knee adduction/abduction angle at heel rise during gait.
Time frame: 1 Day
The gait cycle include seven key events (e.g. initial contact), and each gait has six degrees of freedom, including knee flexion/extension, internal/external rotation, adduction/abduction, anterior/posterior translation, distal/proximal translation, medial/lateral translation. The unit of angle is degree and that of translation is millimetre.
Knee anterior/posterior translation at heel rise during gait.
Time frame: 1 Day
The gait cycle include seven key events (e.g. initial contact), and each gait has six degrees of freedom, including knee flexion/extension, internal/external rotation, adduction/abduction, anterior/posterior translation, distal/proximal translation, medial/lateral translation. The unit of angle is degree and that of translation is millimetre.
Knee distal/proximal translation at heel rise during gait.
Time frame: 1 Day
The gait cycle include seven key events (e.g. initial contact), and each gait has six degrees of freedom, including knee flexion/extension, internal/external rotation, adduction/abduction, anterior/posterior translation, distal/proximal translation, medial/lateral translation. The unit of angle is degree and that of translation is millimetre.
Knee medial/lateral translation at heel rise during gait.
Time frame: 1 Day
The gait cycle include seven key events (e.g. initial contact), and each gait has six degrees of freedom, including knee flexion/extension, internal/external rotation, adduction/abduction, anterior/posterior translation, distal/proximal translation, medial/lateral translation. The unit of angle is degree and that of translation is millimetre.
Knee flexion/extension angle at opposite initial contact during gait.
Time frame: 1 Day
The gait cycle include seven key events (e.g. initial contact), and each gait has six degrees of freedom, including knee flexion/extension, internal/external rotation, adduction/abduction, anterior/posterior translation, distal/proximal translation, medial/lateral translation. The unit of angle is degree and that of translation is millimetre.
Knee internal/external angle at opposite initial contact during gait.
Time frame: 1 Day
The gait cycle include seven key events (e.g. initial contact), and each gait has six degrees of freedom, including knee flexion/extension, internal/external rotation, adduction/abduction, anterior/posterior translation, distal/proximal translation, medial/lateral translation. The unit of angle is degree and that of translation is millimetre.
Knee adduction/abduction angle at opposite initial contact during gait.
Time frame: 1 Day
The gait cycle include seven key events (e.g. initial contact), and each gait has six degrees of freedom, including knee flexion/extension, internal/external rotation, adduction/abduction, anterior/posterior translation, distal/proximal translation, medial/lateral translation. The unit of angle is degree and that of translation is millimetre.
Knee anterior/posterior translation at opposite initial contact during gait.
Time frame: 1 Day
The gait cycle include seven key events (e.g. initial contact), and each gait has six degrees of freedom, including knee flexion/extension, internal/external rotation, adduction/abduction, anterior/posterior translation, distal/proximal translation, medial/lateral translation. The unit of angle is degree and that of translation is millimetre.
Knee distal/proximal translation at opposite initial contact during gait.
Time frame: 1 Day
The gait cycle include seven key events (e.g. initial contact), and each gait has six degrees of freedom, including knee flexion/extension, internal/external rotation, adduction/abduction, anterior/posterior translation, distal/proximal translation, medial/lateral translation. The unit of angle is degree and that of translation is millimetre.
Knee medial/lateral translation at opposite initial contact during gait.
Time frame: 1 Day
The gait cycle include seven key events (e.g. initial contact), and each gait has six degrees of freedom, including knee flexion/extension, internal/external rotation, adduction/abduction, anterior/posterior translation, distal/proximal translation, medial/lateral translation. The unit of angle is degree and that of translation is millimetre.
Knee flexion/extension angle at toe off during gait.
Time frame: 1 Day
The gait cycle include seven key events (e.g. initial contact), and each gait has six degrees of freedom, including knee flexion/extension, internal/external rotation, adduction/abduction, anterior/posterior translation, distal/proximal translation, medial/lateral translation. The unit of angle is degree and that of translation is millimetre.
Knee adduction/abduction angle at toe off during gait.
Time frame: 1 Day
The gait cycle include seven key events (e.g. initial contact), and each gait has six degrees of freedom, including knee flexion/extension, internal/external rotation, adduction/abduction, anterior/posterior translation, distal/proximal translation, medial/lateral translation. The unit of angle is degree and that of translation is millimetre.
Knee internal/external rotation angle at toe off during gait.
Time frame: 1 Day
The gait cycle include seven key events (e.g. initial contact), and each gait has six degrees of freedom, including knee flexion/extension, internal/external rotation, adduction/abduction, anterior/posterior translation, distal/proximal translation, medial/lateral translation. The unit of angle is degree and that of translation is millimetre.
Knee anterior/posterior translation at toe off during gait.
Time frame: 1 Day
The gait cycle include seven key events (e.g. initial contact), and each gait has six degrees of freedom, including knee flexion/extension, internal/external rotation, adduction/abduction, anterior/posterior translation, distal/proximal translation, medial/lateral translation. The unit of angle is degree and that of translation is millimetre.
Knee distal/proximal translation at toe off during gait.
Time frame: 1 Day
The gait cycle include seven key events (e.g. initial contact), and each gait has six degrees of freedom, including knee flexion/extension, internal/external rotation, adduction/abduction, anterior/posterior translation, distal/proximal translation, medial/lateral translation. The unit of angle is degree and that of translation is millimetre.
Knee medial/lateral translation at toe off during gait.
Time frame: 1 Day
The gait cycle include seven key events (e.g. initial contact), and each gait has six degrees of freedom, including knee flexion/extension, internal/external rotation, adduction/abduction, anterior/posterior translation, distal/proximal translation, medial/lateral translation. The unit of angle is degree and that of translation is millimetre.
Knee flexion/extension angle at feet adjacent during gait.
Time frame: 1 Day
The gait cycle include seven key events (e.g. initial contact), and each gait has six degrees of freedom, including knee flexion/extension, internal/external rotation, adduction/abduction, anterior/posterior translation, distal/proximal translation, medial/lateral translation. The unit of angle is degree and that of translation is millimetre.
Knee internal/external rotation angle at feet adjacent during gait.
Time frame: 1 Day
The gait cycle include seven key events (e.g. initial contact), and each gait has six degrees of freedom, including knee flexion/extension, internal/external rotation, adduction/abduction, anterior/posterior translation, distal/proximal translation, medial/lateral translation. The unit of angle is degree and that of translation is millimetre.
Knee adduction/abduction angle at feet adjacent during gait.
Time frame: 1 Day
The gait cycle include seven key events (e.g. initial contact), and each gait has six degrees of freedom, including knee flexion/extension, internal/external rotation, adduction/abduction, anterior/posterior translation, distal/proximal translation, medial/lateral translation. The unit of angle is degree and that of translation is millimetre.
Knee anterior/posterior translation at feet adjacent during gait.
Time frame: 1 Day
The gait cycle include seven key events (e.g. initial contact), and each gait has six degrees of freedom, including knee flexion/extension, internal/external rotation, adduction/abduction, anterior/posterior translation, distal/proximal translation, medial/lateral translation. The unit of angle is degree and that of translation is millimetre.
Knee distal/proximal translation at feet adjacent during gait.
Time frame: 1 Day
The gait cycle include seven key events (e.g. initial contact), and each gait has six degrees of freedom, including knee flexion/extension, internal/external rotation, adduction/abduction, anterior/posterior translation, distal/proximal translation, medial/lateral translation. The unit of angle is degree and that of translation is millimetre.
Knee medial/lateral translation at feet adjacent during gait.
Time frame: 1 Day
The gait cycle include seven key events (e.g. initial contact), and each gait has six degrees of freedom, including knee flexion/extension, internal/external rotation, adduction/abduction, anterior/posterior translation, distal/proximal translation, medial/lateral translation. The unit of angle is degree and that of translation is millimetre.
Knee flexion/extension angle at tibia vertical during gait.
Time frame: 1 Day
The gait cycle include seven key events (e.g. initial contact), and each gait has six degrees of freedom, including knee flexion/extension, internal/external rotation, adduction/abduction, anterior/posterior translation, distal/proximal translation, medial/lateral translation. The unit of angle is degree and that of translation is millimetre.
Knee adduction/abduction angle at tibia vertical during gait.
Time frame: 1 Day
The gait cycle include seven key events (e.g. initial contact), and each gait has six degrees of freedom, including knee flexion/extension, internal/external rotation, adduction/abduction, anterior/posterior translation, distal/proximal translation, medial/lateral translation. The unit of angle is degree and that of translation is millimetre.
Knee internal/external rotation angle at tibia vertical during gait.
Time frame: 1 Day
The gait cycle include seven key events (e.g. initial contact), and each gait has six degrees of freedom, including knee flexion/extension, internal/external rotation, adduction/abduction, anterior/posterior translation, distal/proximal translation, medial/lateral translation. The unit of angle is degree and that of translation is millimetre.
Knee anterior/posterior translation at tibia vertical during gait.
Time frame: 1 Day
The gait cycle include seven key events (e.g. initial contact), and each gait has six degrees of freedom, including knee flexion/extension, internal/external rotation, adduction/abduction, anterior/posterior translation, distal/proximal translation, medial/lateral translation. The unit of angle is degree and that of translation is millimetre.
Knee distal/proximal translation at tibia vertical during gait.
Time frame: 1 Day
The gait cycle include seven key events (e.g. initial contact), and each gait has six degrees of freedom, including knee flexion/extension, internal/external rotation, adduction/abduction, anterior/posterior translation, distal/proximal translation, medial/lateral translation. The unit of angle is degree and that of translation is millimetre.
Knee medial/lateral translation at tibia vertical during gait.
Time frame: 1 Day
The gait cycle include seven key events (e.g. initial contact), and each gait has six degrees of freedom, including knee flexion/extension, internal/external rotation, adduction/abduction, anterior/posterior translation, distal/proximal translation, medial/lateral translation. The unit of angle is degree and that of translation is millimetre.
Range of motion of knee flexion/extension angle.
Time frame: 1 Day
The gait cycle include seven key events (e.g. initial contact), and each gait has six degrees of freedom, including knee flexion/extension, internal/external rotation, adduction/abduction, anterior/posterior translation, distal/proximal translation, medial/lateral translation. The unit of angle is degree and that of translation is millimetre.
Range of motion of knee internal/external rotation angle.
Time frame: 1 Day
The gait cycle include seven key events (e.g. initial contact), and each gait has six degrees of freedom, including knee flexion/extension, internal/external rotation, adduction/abduction, anterior/posterior translation, distal/proximal translation, medial/lateral translation. The unit of angle is degree and that of translation is millimetre.
Range of motion of knee adduction/abduction angle.
Time frame: 1 Day
The gait cycle include seven key events (e.g. initial contact), and each gait has six degrees of freedom, including knee flexion/extension, internal/external rotation, adduction/abduction, anterior/posterior translation, distal/proximal translation, medial/lateral translation. The unit of angle is degree and that of translation is millimetre.
Range of motion of knee anterior/posterior translation.
Time frame: 1 Day
The gait cycle include seven key events (e.g. initial contact), and each gait has six degrees of freedom, including knee flexion/extension, internal/external rotation, adduction/abduction, anterior/posterior translation, distal/proximal translation, medial/lateral translation. The unit of angle is degree and that of translation is millimetre.
Range of motion of knee distal/proximal translation.
Time frame: 1 Day
The gait cycle include seven key events (e.g. initial contact), and each gait has six degrees of freedom, including knee flexion/extension, internal/external rotation, adduction/abduction, anterior/posterior translation, distal/proximal translation, medial/lateral translation. The unit of angle is degree and that of translation is millimetre.
Range of motion of knee medial/lateral translation.
Time frame: 1 Day
The gait cycle include seven key events (e.g. initial contact), and each gait has six degrees of freedom, including knee flexion/extension, internal/external rotation, adduction/abduction, anterior/posterior translation, distal/proximal translation, medial/lateral translation. The unit of angle is degree and that of translation is millimetre.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2017.
- 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.
Yu Zhang, PhD principal investigator
Hospital of Orthopedics, Guangzhou General Hospital of Guangzhou Military Command, 111 Liuhua Road, Guangzhou 510010, 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 Guangzhou General Hospital of Guangzhou Military Command 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 6 inclusion and 12 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 3 Mar 2017. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Knee flexion/extension angle at initial contact during gait. (time frame: 1 Day). The study lists 50 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 3 Mar 2017.