Comparison of Post-operative Knee Range of Motion and Functions Between Intraoperative Complete and Incomplete Patellofemoral Articular Contacts in Patients Undergoing Total Knee Arthroplasty
1 other identifier
interventional
60
1 country
1
Brief Summary
The purpose of this study is to compare clinical outcome in knee range of motion and functions between intraoperative complete and incomplete patellofemoral articular contacts
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Apr 2021
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 20, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2022
CompletedFirst Submitted
Initial submission to the registry
April 21, 2022
CompletedFirst Posted
Study publicly available on registry
April 27, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2022
CompletedApril 27, 2022
April 1, 2021
12 months
April 21, 2022
April 21, 2022
Conditions
Outcome Measures
Primary Outcomes (3)
Knee range of motion (ROM)
Goniometer measure range of motion (minimum 0, maximum 145)
Change from baseline Knee range of motion (ROM) at 3 months, 6 months, and 12 months after surgery
Knee flexion
Goniometer measure knee flexion (minimum 135, maximum 145)
Change from baseline knee flexion at 3 months, 6 months, and 12 months after surgery
Knee extension
Goniometer measure knee extension (minimum -10, maximum 0)
Change from baseline knee extension at 3 months, 6 months, and 12 months after surgery
Secondary Outcomes (4)
Knee Society and Knee Society function score
Change from baseline Knee Society and Knee Society function score at 3 months, 6 months, and 12 months after surgery
New patellar score
Change from baseline new patellar score at 3 months, 6 months, and 12 months after surgery
Oxford knee score
Change from baseline Oxford knee score 3 months, 6 months, and 12 months after surgery
Prevalence of anterior knee pain ,AKP
Change from baseline Prevalence of anterior knee pain ,AKP 3 months, 6 months, and 12 months after surgery
Study Arms (2)
Complete contact
ACTIVE COMPARATORIncomplete contact
ACTIVE COMPARATORInterventions
The patellofemoral condition is in constant contact with the femoral trochlea when the knee is bent from 30 to 90 degrees during the No thumb test.
The patellofemoral condition is in no constant contact with the femoral trochlea when the knee is bent from 30 to 90 degrees during the No thumb test.
Eligibility Criteria
You may qualify if:
- Primary osteoarthritis of knee who were scheduled for a primary total knee arthroplasty
- Age 50-80 year
You may not qualify if:
- Revision surgery
- Bilateral total knee arthroplasty
- History of patellar fracture
- History of patellar chondromalacia
- History of Patellar instability
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Navamindradhiraj University
Dusit, Bangkok, 10300, Thailand
Study Officials
- PRINCIPAL INVESTIGATOR
Satit Thiengwittayaporn, M.D.
satitthh@hotmail.com
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
April 21, 2022
First Posted
April 27, 2022
Study Start
April 20, 2021
Primary Completion
April 1, 2022
Study Completion
December 1, 2022
Last Updated
April 27, 2022
Record last verified: 2021-04