Clinical trial NCT03011112: Can 3D Kinematic Parameters Assess the Symptomatic and Functional Severity of KOA?
Official title: Can Three Dimensional Kinematic Parameters Assess the Symptomatic and Functional Severity of Medial Knee Osteoarthritis?
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Osteoarthritis,Knee
Keywords: Osteoarthritis, Knee
WOMAC
gait
kinematics
Lead sponsor: Guangzhou General Hospital of Guangzhou Military Command
Sponsor class: OTHER
Collaborators: name: Medical Center of Assessment, Prevention and Treatment of Bone & Joint Diseases, Guangdong, China
name: The First Affiliated Hospital of Guangzhou Medical University
First posted: 2017-01-05
Enrollment: 186
Sex: ALL
Minimum age (years): 50
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: All the patients diagnosed with KOA will be recruited via hospital advertisements in this study.

Brief 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.


Eligibility criteria: Inclusion Criteria:

1. age\> 50 years
2. body mass index\<30;
3. confirmed radiographically and assessed according to KL score;
4. knee pain in their knees at least three months;
5. absolute medial compartment KOA according to atlas criteria13;
6. able to walk unaided

Exclusion Criteria:

1. history of knee surgery;
2. Corticosteroid or Sodium Hyaluronate injection within 6 months;
3. neuropathic arthropathy or rheumatoid arthritis;
4. any other muscular or neurological diseases that affected the condition of the lower limbs;
5. any treatments or training (e.g. kneepad) to improve the symptoms of KOA;
6. history of foot/ankle/hip injury or disease;
7. unable to walk independently;
8. history of heart disease;
9. lateral KOA according to atlas criteria13;
10. body mass index\> 30;
11. age\> 90 years;
12. unable to finish the procedure

Primary outcomes:
measure: Knee flexion/extension angle at initial contact during gait.
timeFrame: 1 Day
measure: Knee internal/external rotation angle at initial contact during gait.
timeFrame: 1 Day
measure: Knee adduction/abduction angle at initial contact during gait.
timeFrame: 1 Day
measure: knee anterior/posterior translation at initial contact during gait.
timeFrame: 1 Day
measure: Knee medial/lateral translation at initial contact during gait.
timeFrame: 1 Day
measure: Knee proximal/distal translation at initial contact during gait.
timeFrame: 1 Day
measure: WOMAC
timeFrame: 1 Day
measure: Kellgren/Lawrence Score
timeFrame: 1 Day
measure: Knee flexion/extension angle at opposite toe off during gait.
timeFrame: 1 Day
measure: Knee internal/external rotation angle at opposite toe off during gait.
timeFrame: 1 Day
measure: Knee adduction/abduction angle at opposite toe off during gait.
timeFrame: 1 Day
measure: Knee anterior/posterior translation at opposite toe off during gait.
timeFrame: 1 Day
measure: Knee distal/proximal translation at opposite toe off during gait.
timeFrame: 1 Day
measure: Knee medial/lateral translation at opposite toe off during gait.
timeFrame: 1 Day
measure: Knee flexion/extension angle at heel rise during gait.
timeFrame: 1 Day
measure: Knee internal/external rotation angle at heel rise during gait.
timeFrame: 1 Day
measure: Knee adduction/abduction angle at heel rise during gait.
timeFrame: 1 Day
measure: Knee anterior/posterior translation at heel rise during gait.
timeFrame: 1 Day
measure: Knee distal/proximal translation at heel rise during gait.
timeFrame: 1 Day
measure: Knee medial/lateral translation at heel rise during gait.
timeFrame: 1 Day
measure: Knee flexion/extension angle at opposite initial contact during gait.
timeFrame: 1 Day
measure: Knee internal/external angle at opposite initial contact during gait.
timeFrame: 1 Day
measure: Knee adduction/abduction angle at opposite initial contact during gait.
timeFrame: 1 Day
measure: Knee anterior/posterior translation at opposite initial contact during gait.
timeFrame: 1 Day
measure: Knee distal/proximal translation at opposite initial contact during gait.
timeFrame: 1 Day
measure: Knee medial/lateral translation at opposite initial contact during gait.
timeFrame: 1 Day
measure: Knee flexion/extension angle at toe off during gait.
timeFrame: 1 Day
measure: Knee adduction/abduction angle at toe off during gait.
timeFrame: 1 Day
measure: Knee internal/external rotation angle at toe off during gait.
timeFrame: 1 Day
measure: Knee anterior/posterior translation at toe off during gait.
timeFrame: 1 Day
measure: Knee distal/proximal translation at toe off during gait.
timeFrame: 1 Day
measure: Knee medial/lateral translation at toe off during gait.
timeFrame: 1 Day
measure: Knee flexion/extension angle at feet adjacent during gait.
timeFrame: 1 Day
measure: Knee internal/external rotation angle at feet adjacent during gait.
timeFrame: 1 Day
measure: Knee adduction/abduction angle at feet adjacent during gait.
timeFrame: 1 Day
measure: Knee anterior/posterior translation at feet adjacent during gait.
timeFrame: 1 Day
measure: Knee distal/proximal translation at feet adjacent during gait.
timeFrame: 1 Day
measure: Knee medial/lateral translation at feet adjacent during gait.
timeFrame: 1 Day
measure: Knee flexion/extension angle at tibia vertical during gait.
timeFrame: 1 Day
measure: Knee adduction/abduction angle at tibia vertical during gait.
timeFrame: 1 Day
measure: Knee internal/external rotation angle at tibia vertical during gait.
timeFrame: 1 Day
measure: Knee anterior/posterior translation at tibia vertical during gait.
timeFrame: 1 Day
measure: Knee distal/proximal translation at tibia vertical during gait.
timeFrame: 1 Day
measure: Knee medial/lateral translation at tibia vertical during gait.
timeFrame: 1 Day
measure: Range of motion of knee flexion/extension angle.
timeFrame: 1 Day
measure: Range of motion of knee internal/external rotation angle.
timeFrame: 1 Day
measure: Range of motion of knee adduction/abduction angle.
timeFrame: 1 Day
measure: Range of motion of knee anterior/posterior translation.
timeFrame: 1 Day
measure: Range of motion of knee distal/proximal translation.
timeFrame: 1 Day
measure: Range of motion of knee medial/lateral translation.
timeFrame: 1 Day
Secondary outcomes:
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Hospital of Orthopedics, Guangzhou General Hospital of Guangzhou Military Command
state: Guangdong
Study officials:
affiliation: Hospital of Orthopedics, Guangzhou General Hospital of Guangzhou Military Command, 111 Liuhua Road, Guangzhou 510010, China
name: Yu Zhang, PhD
role: PRINCIPAL_INVESTIGATOR
References: