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CompletedNCT02878239Updated Sep 14, 2016

The Three-dimensional Gait Analysis of Medial Knee Osteoarthritis

An observational study in Osteoarthritis, Knee and Osteoarthritis, sponsored by Guangzhou General Hospital of Guangzhou Military Command. Completed at 1 site in China. Open to participants aged 35 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-09-14.

Sponsored by Guangzhou General Hospital of Guangzhou Military Command · Observational

Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
136
Ages
35 Years to 80 Years
Sex
All
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Study 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.

Read the detailed description

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

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Conditions studied

  • Osteoarthritis, Knee
  • Osteoarthritis

Keywords

  • knee osteoarthritis
  • gait
  • Kellgren-Lawrence Scores
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In context

Osteoarthritis

4,398 studies on the registry are indexed under Osteoarthritis; 582 are open to participants now.

This study's enrollment of 136 is above the median of 100 across 791 observational studies indexed under Osteoarthritis.

Browse Osteoarthritis studies →

Lead sponsor

Guangzhou General Hospital of Guangzhou Military Command is the lead sponsor of 46 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
35 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
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.

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

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.
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Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
136 participants (actual)
Patient registry
No

Groups and cohorts

  • 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

  • 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

  • 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

  • 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

Interventions

  • OtherSteps 1

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

  • OtherSteps 2

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

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What researchers measure

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.

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

    Time frame: 1 Day

  2. 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.

    Time frame: 1 Day

  3. 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.

    Time frame: 1 Day

Secondary outcomes

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

    Time frame: 1 Day

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Study locations

1 site
  • Hospital of Orthopedics, Guangzhou General Hospital of Guangzhou Military Command
    Guangzhou, Guangdong 510010, China
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 14, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02878239
Lead sponsor
Guangzhou General Hospital of Guangzhou Military Command
Collaborators
Medical Center of Assessment, Prevention and Treatment of Bone & Joint Diseases, Guangdong, China, The First Affiliated Hospital of Guangzhou Medical University
Responsible party
Yu Zhang (chief surgeon, associate professor, Guangzhou General Hospital of Guangzhou Military Command) — Principal investigator
First posted
Aug 25, 2016
Start date
Aug 2016
Primary completion
Sep 2016
Completion
Sep 2016
Last update
Sep 14, 2016

Study contacts

Yu Zhang, PhD
study chair · Hospital of Orthopedics, Guangzhou General Hospital of Guangzhou Military Command, 111 Liuhua Road, Guangzhou 510010, China

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Sep 2016. You cannot join it, but the record below documents what was studied.

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