The Three-dimensional Gait Analysis of Medial Knee Osteoarthritis

NCT ID: NCT02878239

Last Updated: 2016-09-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

136 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-08-31

Study Completion Date

2016-09-30

Brief Summary

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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.

Detailed Description

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

Conditions

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Osteoarthritis, Knee Osteoarthritis

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Early OA

All patients (\>35 years) have been diagnosed with medial knee osteoarthritis according to the American College of Rheumatology criteria. Those are classified as patients with early knee osteoarthritis because their Kellgren-Lawrence Scores were Grade I.

Steps 1

Intervention Type OTHER

Kinematic characteristics are obtained by the portal gait analysis system in the patients. Kellgren-Lawrence Scores are obtained according to their radiography.

Moderate OA

All patients (\>35 years) have been diagnosed with medial knee osteoarthritis according to the American College of Rheumatology criteria. Those are classified as patients with moderate knee osteoarthritis because their Kellgren-Lawrence Scores were Grade II.

Steps 1

Intervention Type OTHER

Kinematic characteristics are obtained by the portal gait analysis system in the patients. Kellgren-Lawrence Scores are obtained according to their radiography.

Severe OA

All patients (\>35 years) have been diagnosed with medial knee osteoarthritis according to the American College of Rheumatology criteria. Those are classified as patients with moderate knee osteoarthritis because their Kellgren-Lawrence Scores were Grade III/IV.

Steps 1

Intervention Type OTHER

Kinematic characteristics are obtained by the portal gait analysis system in the patients. Kellgren-Lawrence Scores are obtained according to their radiography.

Asymptomatic Participants

The asymptomatic participants(\>35 years) has no history of knee pain, trauma, surgery, or obvious gait abnormalities. They are set as controls in the study.

Steps 2

Intervention Type OTHER

Kinematic characteristics are obtained by the portal gait analysis system in the subjects.Physical examinations are taken to avoid other diseases.

Interventions

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Steps 1

Kinematic characteristics are obtained by the portal gait analysis system in the patients. Kellgren-Lawrence Scores are obtained according to their radiography.

Intervention Type OTHER

Steps 2

Kinematic characteristics are obtained by the portal gait analysis system in the subjects.Physical examinations are taken to avoid other diseases.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

35 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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

OTHER

Sponsor Role collaborator

The First Affiliated Hospital of Guangzhou Medical University

OTHER

Sponsor Role collaborator

Guangzhou General Hospital of Guangzhou Military Command

OTHER

Sponsor Role lead

Responsible Party

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Yu Zhang

chief surgeon, associate professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Yu Zhang, PhD

Role: STUDY_CHAIR

Hospital of Orthopedics, Guangzhou General Hospital of Guangzhou Military Command, 111 Liuhua Road, Guangzhou 510010, China

Locations

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Hospital of Orthopedics, Guangzhou General Hospital of Guangzhou Military Command

Guangzhou, Guangdong, China

Site Status

Countries

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China

Other Identifiers

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GuangzhouGH001

Identifier Type: -

Identifier Source: org_study_id

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