Can 3D Kinematic Parameters Assess the Symptomatic and Functional Severity of KOA?

Osteoarthritis,Knee Clinical Trial

Official title:

Can Three Dimensional Kinematic Parameters Assess the Symptomatic and Functional Severity of Medial Knee Osteoarthritis?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03011112
• Other study ID #: GuangzhouGH003
• Status: Completed
• Phase: N/A
• First received: January 3, 2017
• Last updated: March 1, 2017
• Start date: January 2, 2017
• Est. completion date: February 28, 2017

Study information

• Verified date: March 2017
• Source: Guangzhou General Hospital of Guangzhou Military Command
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 186
• Est. completion date: February 28, 2017
• Est. primary completion date: February 20, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis, Knee
• Osteoarthritis,Knee

Intervention

Procedure:
• Observational procedure
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.

Locations

Country	Name	City	State
China	Hospital of Orthopedics, Guangzhou General Hospital of Guangzhou Military Command	Guangzhou	Guangdong

Sponsors (3)

Lead Sponsor	Collaborator
Guangzhou General Hospital of Guangzhou Military Command	Guangdong Key Laboratory of Orthopaedic Technology and Implant Material, Guangdong Province, Medical Center of Assessment, Prevention and Treatment of Bone & Joint Diseases

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	1 Day
Primary	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.	1 Day
Primary	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.	1 Day
Primary	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.	1 Day
Primary	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.	1 Day
Primary	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.	1 Day
Primary	WOMAC	The Western Ontario and McMaster Universities Osteoarthritis Index	1 Day
Primary	Kellgren/Lawrence Score		1 Day
Primary	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.	1 Day
Primary	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.	1 Day
Primary	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.	1 Day
Primary	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.	1 Day
Primary	Knee distal/proximal translation at opposite toe off during gait.		1 Day
Primary	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.	1 Day
Primary	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.	1 Day
Primary	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.	1 Day
Primary	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.	1 Day
Primary	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.	1 Day
Primary	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.	1 Day
Primary	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.	1 Day
Primary	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.	1 Day
Primary	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.	1 Day
Primary	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.	1 Day
Primary	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.	1 Day
Primary	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.	1 Day
Primary	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.	1 Day
Primary	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.	1 Day
Primary	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.	1 Day
Primary	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.	1 Day
Primary	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.	1 Day
Primary	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.	1 Day
Primary	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.	1 Day
Primary	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.	1 Day
Primary	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.	1 Day
Primary	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.	1 Day
Primary	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.	1 Day
Primary	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.	1 Day
Primary	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.	1 Day
Primary	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.	1 Day
Primary	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.	1 Day
Primary	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.	1 Day
Primary	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.	1 Day
Primary	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.	1 Day
Primary	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.	1 Day
Primary	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.	1 Day
Primary	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.	1 Day
Primary	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.	1 Day
Primary	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.	1 Day
Primary	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.	1 Day
Primary	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.	1 Day