The Three-dimensional Gait Analysis of Medial Knee Osteoarthritis

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.

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.

Study Overview

• Status: Completed
• Conditions: Osteoarthritis; Osteoarthritis, Knee
• Intervention / Treatment: Other: Steps 1; Other: Steps 2

Detailed Description

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

• Study Type: Observational
• Enrollment (Actual): 136

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510010
      • Hospital of Orthopedics, Guangzhou General Hospital of Guangzhou Military Command

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Chinese patients diagnosed with medial KOA andasymptomatic participants will be recruited. The asymptomatic participants（>35 years） have no history of knee pain, trauma, surgery, or obvious gait abnormalities.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	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.
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.	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.
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.	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.
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.	Other: Steps 2; Kinematic characteristics are obtained by the portal gait analysis system in the subjects.Physical examinations are taken to avoid other diseases.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Secondary Outcome Measures

Outcome Measure	Time Frame
Kellgren-Lawrence Scores in patients with knee osteoarthritis.	1 Day

Collaborators and Investigators

• Sponsor: Guangzhou General Hospital of Guangzhou Military Command
• Collaborators: The First Affiliated Hospital of Guangzhou Medical University; Medical Center of Assessment, Prevention and Treatment of Bone & Joint Diseases, Guangdong, China
• Investigators: Study Chair: Yu Zhang, PhD, Hospital of Orthopedics, Guangzhou General Hospital of Guangzhou Military Command, 111 Liuhua Road, Guangzhou 510010, China

Study record dates

Study Major Dates

• Study Start: August 1, 2016
• Primary Completion (Actual): September 1, 2016
• Study Completion (Actual): September 1, 2016

Study Registration Dates

• First Submitted: August 16, 2016
• First Submitted That Met QC Criteria: August 21, 2016
• First Posted (Estimate): August 25, 2016

Study Record Updates

• Last Update Posted (Estimate): September 14, 2016
• Last Update Submitted That Met QC Criteria: September 13, 2016
• Last Verified: September 1, 2016

More Information

Terms related to this study

• Keywords: knee osteoarthritis; gait; Kellgren-Lawrence Scores
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee
• Other Study ID Numbers: GuangzhouGH001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No