- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03011112
Can 3D Kinematic Parameters Assess the Symptomatic and Functional Severity of KOA?
March 1, 2017 updated by: Yu Zhang, Guangzhou General Hospital of Guangzhou Military Command
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
186
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Guangdong
-
Guangzhou, Guangdong, China, 510010
- Hospital of Orthopedics, Guangzhou General Hospital of Guangzhou Military Command
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
50 years to 90 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
All the patients diagnosed with KOA will be recruited via hospital advertisements in this study.
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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;
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
KL 1
All patients (>50 years) are classified to be Kellgrence/Lawrence grade 1 according to Kellgrence/Lawrence score.
|
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.
|
KL 2
All patients (>50 years) are classified to be Kellgrence/Lawrence grade 2 according to Kellgrence/Lawrence score.
|
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.
|
KL 3
All patients (>50 years) are classified to be Kellgrence/Lawrence grade 3 according to Kellgrence/Lawrence score.
|
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.
|
KL 4
All patients (>50 years) are classified to be Kellgrence/Lawrence grade 4 according to Kellgrence/Lawrence score.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
1 Day
|
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.
|
1 Day
|
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.
|
1 Day
|
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.
|
1 Day
|
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.
|
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.
|
1 Day
|
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.
|
1 Day
|
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.
|
1 Day
|
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.
|
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.
|
1 Day
|
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.
|
1 Day
|
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.
|
1 Day
|
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.
|
1 Day
|
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.
|
1 Day
|
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.
|
1 Day
|
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.
|
1 Day
|
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.
|
1 Day
|
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.
|
1 Day
|
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.
|
1 Day
|
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.
|
1 Day
|
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.
|
1 Day
|
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.
|
1 Day
|
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.
|
1 Day
|
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.
|
1 Day
|
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.
|
1 Day
|
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.
|
1 Day
|
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.
|
1 Day
|
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.
|
1 Day
|
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.
|
1 Day
|
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.
|
1 Day
|
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.
|
1 Day
|
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.
|
1 Day
|
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.
|
1 Day
|
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.
|
1 Day
|
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.
|
1 Day
|
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.
|
1 Day
|
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.
|
1 Day
|
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.
|
1 Day
|
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.
|
1 Day
|
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.
|
1 Day
|
WOMAC
Time Frame: 1 Day
|
The Western Ontario and McMaster Universities Osteoarthritis Index
|
1 Day
|
Kellgren/Lawrence Score
Time Frame: 1 Day
|
1 Day
|
|
Knee distal/proximal translation at opposite toe off during gait.
Time Frame: 1 Day
|
1 Day
|
|
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.
|
1 Day
|
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.
|
1 Day
|
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.
|
1 Day
|
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.
|
1 Day
|
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.
|
1 Day
|
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.
|
1 Day
|
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.
|
1 Day
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
January 2, 2017
Primary Completion (ACTUAL)
February 20, 2017
Study Completion (ACTUAL)
February 28, 2017
Study Registration Dates
First Submitted
January 3, 2017
First Submitted That Met QC Criteria
January 3, 2017
First Posted (ESTIMATE)
January 5, 2017
Study Record Updates
Last Update Posted (ACTUAL)
March 3, 2017
Last Update Submitted That Met QC Criteria
March 1, 2017
Last Verified
March 1, 2017
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- GuangzhouGH003
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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