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The Three-dimensional Gait Analysis of Medial Knee Osteoarthritis

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ClinicalTrials.gov Identifier: NCT02878239
Recruitment Status : Completed
First Posted : August 25, 2016
Last Update Posted : September 14, 2016
Sponsor:
Collaborators:
Medical Center of Assessment, Prevention and Treatment of Bone & Joint Diseases, Guangdong, China
The First Affiliated Hospital of Guangzhou Medical University
Information provided by (Responsible Party):
Yu Zhang, Guangzhou General Hospital of Guangzhou Military Command

Brief 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.

Condition or disease Intervention/treatment
Osteoarthritis, Knee Osteoarthritis Other: Steps 1 Other: Steps 2

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

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Study Type : Observational
Actual Enrollment : 136 participants
Observational Model: Case Control
Time Perspective: Prospective
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.
Study Start Date : August 2016
Actual Primary Completion Date : September 2016
Actual Study Completion Date : September 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

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.




Primary Outcome Measures :
  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 Outcome Measures :
  1. Kellgren-Lawrence Scores in patients with knee osteoarthritis. [ Time Frame: 1 Day ]


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Ages Eligible for Study:   35 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   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.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02878239


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

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Responsible Party: Yu Zhang, chief surgeon, associate professor, Guangzhou General Hospital of Guangzhou Military Command
ClinicalTrials.gov Identifier: NCT02878239     History of Changes
Other Study ID Numbers: GuangzhouGH001
First Posted: August 25, 2016    Key Record Dates
Last Update Posted: September 14, 2016
Last Verified: September 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Yu Zhang, Guangzhou General Hospital of Guangzhou Military Command:
knee osteoarthritis
gait
Kellgren-Lawrence Scores

Additional relevant MeSH terms:
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Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases