Osteoarthritis, KneeNCT02878239
The Three-dimensional Gait Analysis of Medial Knee Osteoarthritis
An observational study of Osteoarthritis, Knee and Osteoarthritis, run by Guangzhou General Hospital of Guangzhou Military Command at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 35 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Osteoarthritis, Knee, Osteoarthritis
- What is being tested?
- Steps 1 and Steps 2
- Type of treatment
- Injection or infusion
- How many people
- 136 participants
- Where
- 1 siteChina
- Study dates
- Aug 2016to Sep 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Hospital of Orthopedics, Guangzhou General Hospital of Guangzhou Military Command
Guangzhou, Guangdong, 510010
About this study
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.
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.
- Conditions
- Osteoarthritis, Knee, Osteoarthritis
- Being tested
- Steps 1, Steps 2
- Keywords
- knee osteoarthritis, gait, Kellgren-Lawrence Scores
- Medical subject headings
- Osteoarthritis, Knee, Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Steps 1Other
Kinematic characteristics are obtained by the portal gait analysis system in the patients. Kellgren-Lawrence Scores are obtained according to their radiography.
Steps 2Other
Kinematic characteristics are obtained by the portal gait analysis system in the subjects.Physical examinations are taken to avoid other diseases.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. Receives: Other: Steps 2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 1 Day
Secondary outcomes (1)
Kellgren-Lawrence Scores in patients with knee osteoarthritis.
Measured: 1 Day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2016 (estimated)
- Study startAug 2016
- Primary completionSep 2016
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoarthritis, KneeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 136 participants (actual)
Sponsor and investigators
- Lead sponsor
- Guangzhou General Hospital of Guangzhou Military Command
- Sponsor type
- University, hospital or other
- Collaborators
- Medical Center of Assessment, Prevention and Treatment of Bone & Joint Diseases, Guangdong, China, The First Affiliated Hospital of Guangzhou Medical University
- Responsible party
- Principal investigator, Yu Zhang, Guangzhou General Hospital of Guangzhou Military Command
- Investigators
- Yu Zhang, PhD, Study chair, Hospital of Orthopedics, Guangzhou General Hospital of Guangzhou Military Command, 111 Liuhua Road, Guangzhou 510010, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02878239
- Sponsor's protocol ID
- GuangzhouGH001
- Status last verified
- Sep 2016
- First submitted
- 16 Aug 2016
- Last updated
- 14 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT02878239
- Acronym / sponsor ID
- GuangzhouGH001
- Conditions
- Osteoarthritis, Knee, Osteoarthritis
- Keywords
- knee osteoarthritis, gait, Kellgren-Lawrence Scores
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 136 participants (actual)
- Lead sponsor
- Guangzhou General Hospital of Guangzhou Military CommandUniversity, hospital or other
- Collaborators
- Medical Center of Assessment, Prevention and Treatment of Bone & Joint Diseases, Guangdong, China, The First Affiliated Hospital of Guangzhou Medical University
- Study start
- Aug 2016
- Primary completion
- Sep 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 25 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
All patients are assessed according to the Kellgren-Lawrence Score.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Early OA | – | Other: Steps 1All 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. |
| Moderate OA | – | Other: Steps 1All 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. |
| Severe OA | – | Other: Steps 1All 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. |
| Asymptomatic Participants | – | Other: Steps 2The asymptomatic participants（>35 years） has no history of knee pain, trauma, surgery, or obvious gait abnormalities. They are set as controls in the study. |
Who may qualify
- Ages
- 35 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Steps 1Kinematic characteristics are obtained by the portal gait analysis system in the patients. Kellgren-Lawrence Scores are obtained according to their radiography. | Other | Early OA, Moderate OA, Severe OA |
| Steps 2Kinematic characteristics are obtained by the portal gait analysis system in the subjects.Physical examinations are taken to avoid other diseases. | Other | Asymptomatic Participants |
Primary outcome
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.
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.
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.
1 secondary outcome
Kellgren-Lawrence Scores in patients with knee osteoarthritis.
Time frame: 1 Day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2016.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yu Zhang, PhD study chair
Hospital of Orthopedics, Guangzhou General Hospital of Guangzhou Military Command, 111 Liuhua Road, Guangzhou 510010, China
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Osteoarthritis, Knee and Osteoarthritis, run by Guangzhou General Hospital of Guangzhou Military Command at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2016.