The Three-dimensional Gait Analysis of Medial Knee Osteoarthritis

Osteoarthritis Clinical Trial

Official title:

The Relationship Between the Imaging Assessment Based on Kellgren-Lawrence Scores and In Vivo 3D Knee Kinematic Characteristics in Chinese Patients With Medial Knee Osteoarthritis During Walking Using a New Portal Gait System.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02878239
• Other study ID #: GuangzhouGH001
• Status: Completed
• Phase: N/A
• First received: August 16, 2016
• Last updated: September 13, 2016
• Start date: August 2016
• Est. completion date: September 2016

Study information

• Verified date: September 2016
• Source: Guangzhou General Hospital of Guangzhou Military Command
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Health and Family Planning Commission of Guangdong Province
• Study type: Observational

Clinical Trial Summary

Static imaging has been commonly and clinically accepted to assess the severity of medial knee osteoarthritis (KOA), especially the radiography. Gait analysis has been adopted to evaluate the kinematic characteristics of the knees in patients with KOA. Most of the current studies focus on the sagittal plane of the knee, but very few of them focus on the frontal or horizontal plane. With the different severity of medial KOA, anatomical structures of the knees will change and influence kinematics of the knees, such as osteophytes and deformity. At present, there has been no study focusing on the relations between the imaging assessment of the severity and quantitative kinematics of medial KOA. The aim of the study is to explore the relationship between the imaging assessment based on the Kellgren-Lawrence Scores and in vivo 3D knee kinematic characteristics in Chinese patients with medial KOA during walking using a new portal gait system.

Description:

All patients are assessed according to the Kellgren-Lawrence Score.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 136
• Est. completion date: September 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 35 Years to 80 Years

Eligibility

Inclusion Criteria:

1. Clinical diagnosis of medial knee osteoarthritis according to the American College of Rheumatology criteria.

2. The patients are confirmed by radiographic evidence that medial tibiofemoral joint space grade was narrower than lateral tibiofemoral joint space.

3. The patients have clinical symptom of medial pain of the knee.

4. Clinical examinations are taken to examine the asymptomatic subjects to avoid knee diseases.

Exclusion Criteria:

1. Traumatic knee osteoarthritis.

2. Lateral tibiofemoral KOA or any other types of Knee OA.

3. Ambiguity of Kellgren-Lawrence scores

4. History of surgery.

5. Neuromuscular disease, cardiovascular disease or trauma that can affects gait.

6. Body mass index greater than 35.

7. Needing stick or assistance to walk or unable to walk at a speed of less than 2.0 km/h and less than 300 m.

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Other:
• Steps 1
Kinematic characteristics are obtained by the portal gait analysis system in the patients. Kellgren-Lawrence Scores are obtained according to their radiography.
• Steps 2
Kinematic characteristics are obtained by the portal gait analysis system in the subjects.Physical examinations are taken to avoid other diseases.

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, Medical Center of Assessment, Prevention and Treatment of Bone & Joint Diseases, Guangdong, China

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Kinematic characteristics of the the six-degree-of-motion (6DOF) of the gait at heel strike in asymptomatic participants and patients with knee osteoarthritis.	The 6DOF include flexion/extension, internal/external rotation, varus/valgus, anterior/posterior translation, medial/lateral translation, proximal/distal translation.	1 Day	No
Primary	Kinematic characteristics of the 6DOF of the gait at the mid-stance phase in asymptomatic participants and patients with knee osteoarthritis.	The 6DOF include flexion/extension, internal/external rotation, varus/valgus, anterior/posterior translation, medial/lateral translation, proximal/distal translation.	1 Day	No
Primary	Kinematic characteristics of the 6DOF of the gait at the maximum motion in swing phase in asymptomatic participants and patients with knee osteoarthritis.	The 6DOF include flexion/extension, internal/external rotation, varus/valgus, anterior/posterior translation, medial/lateral translation, proximal/distal translation.	1 Day	No
Secondary	Kellgren-Lawrence Scores in patients with knee osteoarthritis.		1 Day	No