OsteoarthritisNCT02557763
To Compare Anterior Knee Pain Between Non Severe and Severe Patellofemoral Arthritis After Oxford UKA
A study testing Oxford unicompartmental knee arthroplasty in people with Osteoarthritis, run by Thammasat University at 1 site in Thailand.
Trial summary
The aims of this study is to compare the results between patients without severe patellofemoral arthritis and patients with severe patellofemoral arthritis after mobile bearing UKA. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- Oxford unicompartmental knee arthroplasty
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteThailand
- Study dates
- Jan 2011to Apr 2015
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- anteromedial osteoarthritis knee,
- older than 40 years old,
- range of motion > 90 degrees,
- varus deformity < 25degrees,
- flexion contracture< 20degrees,
- intact anterior cruciate ligament
Who cannot join
- younger than 40,
- osteonecrosis of knee,
- rheumatoid,
- posttraumatic arthritis,
- absent of anterior cruciate ligament
Trial locations and contacts
1 site in 1 country.
Thailand1 site
Boonchana Pongcharoen
Pathum Thani, Changwat Pathum Thani, 12120
About this study
Official title: Study of Oxford Unicompartmental Knee Arthroplasty to Determine Anterior Knee Pain, Pain Score, Knee Score and Functional Score Between Patients Without Severe Patellofemoral Arthritis and Patients With Severe Patellofemoral Arthritis
The aims of this study is to compare the results between patients without severe patellofemoral arthritis and patients with severe patellofemoral arthritis after mobile bearing UKA.
The investigators prospective compute the results including anterior knee pain, knee society score, pain score, functional score, range of motion, operative time, blood loss, and component alignment.
Read the detailed description
The patients were performed surgery. The Oxford UKA was applied for all patient.
- Conditions
- Osteoarthritis
- Being tested
- Oxford unicompartmental knee arthroplasty
- Keywords
- Oxford UKA, anterior knee pain, lateral facet of patella
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oxford unicompartmental knee arthroplastyDevice
Also called Oxford UKA
The patients with medial osteoarthritis knee with patellofemoral arthritis were performed surgery and applied Oxford unicompartmental knee arthroplasty.
| Study group | Role | What they receive |
|---|---|---|
| Severe PF arthritis | Experimental | Oxford unicompartmental knee arthroplasty is partial knee replacement. Oxford unicompartmental knee arthroplasty is applied for medial compartmental of knee. Receives: Device: Oxford unicompartmental knee arthroplasty |
| non severe PF arthritis | Experimental | Oxford unicompartmental knee arthroplasty is partial knee replacement. Oxford unicompartmental knee arthroplasty is applied for medial compartmental of knee. Receives: Device: Oxford unicompartmental knee arthroplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
visual analog scale for anterior knee pain
The 10-point visual analog scale is 0 representing no pain and 10 representing maximum pain experience.
Measured: 1 year
Secondary outcomes (1)
Knee society score
The standard clinical evaluation system for reporting results for patients undergoing unicompartmental knee arthroplasty
Measured: 1year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2015 (estimated)
- Study startJan 2011
- Primary completionApr 2015
- Study completionApr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoarthritisStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Thammasat University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Boonchana Pongcharoen, Thammasat University
- Investigators
- Boonchana Pongcharoen, MD, Principal investigator, Thammasat University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02557763
- Sponsor's protocol ID
- MTU-EC-OT-0-091/57
- Status last verified
- Aug 2021
- First submitted
- 7 May 2015
- Last updated
- 2 Sep 2021
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Oxford Unicompartmental Knee Arthroplasty to Determine Anterior Knee Pain, Pain Score, Knee Score and Functional Score Between Patients Without Severe Patellofemoral Arthritis and Patients With Severe Patellofemoral Arthritis
- ClinicalTrials.gov ID
- NCT02557763
- Acronym / sponsor ID
- MTU-EC-OT-0-091/57
- Conditions
- Osteoarthritis
- Keywords
- Oxford UKA, anterior knee pain, lateral facet of patella
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Thammasat UniversityUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- Apr 2015 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 23 Sep 2015 (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 aims of this study is to compare the results between patients without severe patellofemoral arthritis and patients with severe patellofemoral arthritis after mobile bearing UKA.
The investigators prospective compute the results including anterior knee pain, knee society score, pain score, functional score, range of motion, operative time, blood loss, and component alignment.
Detailed description
The patients were performed surgery. The Oxford UKA was applied for all patient.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Severe PF arthritis | Experimental | Device: Oxford unicompartmental knee arthroplastyOxford unicompartmental knee arthroplasty is partial knee replacement. Oxford unicompartmental knee arthroplasty is applied for medial compartmental of knee. |
| non severe PF arthritis | Experimental | Device: Oxford unicompartmental knee arthroplastyOxford unicompartmental knee arthroplasty is partial knee replacement. Oxford unicompartmental knee arthroplasty is applied for medial compartmental of knee. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- anteromedial osteoarthritis knee,
- older than 40 years old,
- range of motion > 90 degrees,
- varus deformity < 25degrees,
- flexion contracture< 20degrees,
Key exclusion criteria (5 listed)
- younger than 40,
- osteonecrosis of knee,
- rheumatoid,
- posttraumatic arthritis,
- absent of anterior cruciate ligament
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 |
|---|---|---|
| Oxford unicompartmental knee arthroplastyAlso: Oxford UKAThe patients with medial osteoarthritis knee with patellofemoral arthritis were performed surgery and applied Oxford unicompartmental knee arthroplasty. | Device | Severe PF arthritis, non severe PF arthritis |
Primary outcome
visual analog scale for anterior knee pain
Time frame: 1 year
The 10-point visual analog scale is 0 representing no pain and 10 representing maximum pain experience.
1 secondary outcome
Knee society score
Time frame: 1year
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 2 Sep 2021.
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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.
Boonchana Pongcharoen, MD principal investigator
Thammasat University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oxford unicompartmental knee arthroplasty in people with Osteoarthritis, 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 6 inclusion and 5 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 2 Sep 2021. 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?
visual analog scale for anterior knee pain (time frame: 1 year). 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 2 Sep 2021.