Severity of OA KneeOA kneeNCT02051699
One-Leg Standing Radiograph: A Novel Technique to Evaluate the Severity of OA Knee
An observational study of Severity of OA Knee and Difference of Joint Space Width Between One-leg and Both-leg Standing Radiograph, run by Thammasat University at 1 site in Thailand.
Trial summary
The purpose of this study is assess the severity of osteoarthritic knee between one-leg and both-leg standing radiograph in primary OA knee Read more about this study
- Who is it for?
- Ages 40 to 90 years
- Conditions the study is for
- Severity of OA Knee, Difference of Joint Space Width Between One-leg and Both-leg Standing Radiograph
- What is being tested?
- radiographic of standing knee
- Type of treatment
- Surgery or procedure
- How many people
- 50 participants
- Where
- 1 siteThailand
- Study dates
- Jun 2012to Feb 2013
- How long will I take part?
- 1 Day
- 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 40 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: the patients who came to our clinic which bilateral knee pain
Who may be able to join
- Bilateral knee pain more than 3 months
Who cannot join
- Inflammatory OA knee
- previous knee injury
- previous knee infection
- previous knee surgery
- pregnant women
- unable to bear weight on one leg
Trial locations and contacts
1 site in 1 country.
Thailand1 site
department of orthopaedic surgery, Faculty of medicine, Thammasat university
Khlong Luang, Changwat Pathum Thani, 066
About this study
Official title: One-Leg Standing Radiograph: A Novel Technique to Evaluate the Severity of Knee Osteoarthritis
The purpose of this study is assess the severity of osteoarthritic knee between one-leg and both-leg standing radiograph in primary OA knee
Read the detailed description
All patients were performed digital radiographs which one-leg and both-leg standing anteroposterior view. Medial and lateral joint space width were measured. The severity of OA knee was identified by the Kellgren-Lawrence (KL) classification.
- Conditions
- Severity of OA Knee, Difference of Joint Space Width Between One-leg and Both-leg Standing Radiograph
- Being tested
- radiographic of standing knee
- Keywords
- Osteoarthritis of the knee, Weight bearing radiograph, Kellgren-Lawrence classification, Joint space width, One-leg standing view
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
radiographic of standing kneeProcedure or surgery
the patients stand on their one leg with pillar support and both-leg then shoot the x-ray beam to their knee
| Study group | Role | What they receive |
|---|---|---|
| One-leg standing view | Not described Receives: Procedure: radiographic of standing knee | |
| both-leg standing view | Not described Receives: Procedure: radiographic of standing knee |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of joint space with between one-leg standing and both-leg standing radiographs in OA knee patients
Measured: one day
Secondary outcomes (1)
Change of radiographic grading between one-leg and both-leg standing AP views in OA knee patients
Measured: one day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2014 (estimated)
- Study startJun 2012
- Primary completionNov 2012
- Study completionFeb 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Severity of OA 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
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Thammasat University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Supakit Kanitnate, Thammasat University
- Investigators
- supakit kanitnate, M.D., Principal investigator, orthopaedic department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02051699
- Sponsor's protocol ID
- orthoTU04
- Acronym
- OA knee
- Status last verified
- Jan 2014
- First submitted
- 30 Jan 2014
- Last updated
- 31 Jan 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- One-Leg Standing Radiograph: A Novel Technique to Evaluate the Severity of Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT02051699
- Acronym / sponsor ID
- OA knee / orthoTU04
- Conditions
- Severity of OA Knee, Difference of Joint Space Width Between One-leg and Both-leg Standing Radiograph
- Keywords
- Osteoarthritis of the knee, Weight bearing radiograph, Kellgren-Lawrence classification, Joint space width, One-leg standing view
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Thammasat UniversityUniversity, hospital or other
- Study start
- Jun 2012
- Primary completion
- Nov 2012 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 31 Jan 2014 (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.
The purpose of this study is assess the severity of osteoarthritic knee between one-leg and both-leg standing radiograph in primary OA knee
Detailed description
All patients were performed digital radiographs which one-leg and both-leg standing anteroposterior view. Medial and lateral joint space width were measured. The severity of OA knee was identified by the Kellgren-Lawrence (KL) classification.
Study design
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| One-leg standing view | – | Procedure: radiographic of standing knee |
| both-leg standing view | – | Procedure: radiographic of standing knee |
Who may qualify
- Ages
- 40 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- the patients who came to our clinic which bilateral knee pain
Key inclusion criteria (1 listed)
- Bilateral knee pain more than 3 months
Key exclusion criteria (6 listed)
- Inflammatory OA knee
- previous knee injury
- previous knee infection
- previous knee surgery
- pregnant women
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 |
|---|---|---|
| radiographic of standing kneethe patients stand on their one leg with pillar support and both-leg then shoot the x-ray beam to their knee | Procedure or surgery | One-leg standing view, both-leg standing view |
Primary outcome
Change of joint space with between one-leg standing and both-leg standing radiographs in OA knee patients
Time frame: one day
1 secondary outcome
Change of radiographic grading between one-leg and both-leg standing AP views in OA knee patients
Time frame: one 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 31 Jan 2014.
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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.
supakit kanitnate, M.D. principal investigator
orthopaedic department
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 Severity of OA Knee and Difference of Joint Space Width Between One-leg and Both-leg Standing Radiograph, run by Thammasat University at 1 site in Thailand.
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 1 inclusion and 6 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 31 Jan 2014. 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 Thailand. 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?
Change of joint space with between one-leg standing and both-leg standing radiographs in OA knee patients (time frame: one day). 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 31 Jan 2014.