- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02557763
To Compare Anterior Knee Pain Between Non Severe and Severe Patellofemoral Arthritis After Oxford UKA
August 29, 2021 updated by: Boonchana Pongcharoen, Thammasat University
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
The patients were performed surgery.
The Oxford UKA was applied for all patient.
Study Type
Interventional
Enrollment (Actual)
100
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Pathumthani
-
Pathum Thani, Pathumthani, Thailand, 12120
- Boonchana Pongcharoen
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
40 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- anteromedial osteoarthritis knee,
- older than 40 years old,
- range of motion > 90 degrees,
- varus deformity < 25degrees,
- flexion contracture< 20degrees,
- intact anterior cruciate ligament
Exclusion Criteria:
- younger than 40,
- osteonecrosis of knee,
- rheumatoid,
- posttraumatic arthritis,
- absent of anterior cruciate ligament
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Severe PF arthritis
Oxford unicompartmental knee arthroplasty is partial knee replacement.
Oxford unicompartmental knee arthroplasty is applied for medial compartmental of knee.
|
The patients with medial osteoarthritis knee with patellofemoral arthritis were performed surgery and applied Oxford unicompartmental knee arthroplasty.
Other Names:
|
|
Experimental: non severe PF arthritis
Oxford unicompartmental knee arthroplasty is partial knee replacement.
Oxford unicompartmental knee arthroplasty is applied for medial compartmental of knee.
|
The patients with medial osteoarthritis knee with patellofemoral arthritis were performed surgery and applied Oxford unicompartmental knee arthroplasty.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Knee society score
Time Frame: 1year
|
The standard clinical evaluation system for reporting results for patients undergoing unicompartmental knee arthroplasty
|
1year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Boonchana Pongcharoen, MD, Thammasat University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2011
Primary Completion (Actual)
April 1, 2015
Study Completion (Actual)
April 1, 2015
Study Registration Dates
First Submitted
May 7, 2015
First Submitted That Met QC Criteria
September 22, 2015
First Posted (Estimate)
September 23, 2015
Study Record Updates
Last Update Posted (Actual)
September 2, 2021
Last Update Submitted That Met QC Criteria
August 29, 2021
Last Verified
August 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MTU-EC-OT-0-091/57
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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