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NCT Number: NCT02878239

The Three-dimensional Gait Analysis of Medial Knee Osteoarthritis

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.

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Key information

Conditions

Osteoarthritis, Knee Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Rheumatic Diseases

Age range

35 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital of Orthopedics, Guangzhou General Hospital of Guangzhou Military Command

Guangzhou, Guangdong, 510010, China

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Clinical diagnosis of medial knee osteoarthritis according to the American College of Rheumatology criteria.
  • The patients are confirmed by radiographic evidence that medial tibiofemoral joint space grade was narrower than lateral tibiofemoral joint space.
  • The patients have clinical symptom of medial pain of the knee.
  • Clinical examinations are taken to examine the asymptomatic subjects to avoid knee diseases.

Exclusion criteria

  • Traumatic knee osteoarthritis.
  • Lateral tibiofemoral KOA or any other types of Knee OA.
  • Ambiguity of Kellgren-Lawrence scores
  • History of surgery.
  • Neuromuscular disease, cardiovascular disease or trauma that can affects gait.
  • Body mass index greater than 35.
  • 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.

Treatment and study plan

Steps 1

Other

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

Steps 2

Other

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

Primary outcomes

  1. Kinematic characteristics of the the six-degree-of-motion (6DOF) of the gait at heel strike in asymptomatic participants and patients with knee osteoarthritis.

    Time frame: 1 Day

    The 6DOF include flexion/extension, internal/external rotation, varus/valgus, anterior/posterior translation, medial/lateral translation, proximal/distal translation.

  2. Kinematic characteristics of the 6DOF of the gait at the mid-stance phase in asymptomatic participants and patients with knee osteoarthritis.

    Time frame: 1 Day

    The 6DOF include flexion/extension, internal/external rotation, varus/valgus, anterior/posterior translation, medial/lateral translation, proximal/distal translation.

  3. Kinematic characteristics of the 6DOF of the gait at the maximum motion in swing phase in asymptomatic participants and patients with knee osteoarthritis.

    Time frame: 1 Day

    The 6DOF include flexion/extension, internal/external rotation, varus/valgus, anterior/posterior translation, medial/lateral translation, proximal/distal translation.

Secondary outcomes

  1. Kellgren-Lawrence Scores in patients with knee osteoarthritis.

    Time frame: 1 Day

Sponsors and collaborators

Lead sponsor

Guangzhou General Hospital of Guangzhou Military Command

Other

Collaborators

  • Medical Center of Assessment, Prevention and Treatment of Bone & Joint Diseases, Guangdong, China
  • The First Affiliated Hospital of Guangzhou Medical University

Registry information

Official study 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.

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Aug 25, 2016
Registry last updated
Sep 14, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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