Incidence of Patellar Crepitus in Removal and Non-removal of Fibrosynovial Tissue at Superior Pole of Patella
Prospective Randomized Controlled Trial: Comparison of Incidence of Patellar Crepitus Between Removal and Non-removal of Fibrosynovial Tissue at the Border of the Superior Pole of the Patellar
1 other identifier
interventional
138
1 country
1
Brief Summary
The purpose of this study is to compare the incidence of patellar crepitus complication and the clinical outcome between remove and not remove fibrosynovial tissue at the border of the superior pole of the patellar in posterior stabilized total knee arthroplasty.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jun 2020
Typical duration for not_applicable
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
First Submitted
Initial submission to the registry
June 10, 2020
CompletedStudy Start
First participant enrolled
June 10, 2020
CompletedFirst Posted
Study publicly available on registry
June 12, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2022
CompletedAugust 31, 2021
August 1, 2021
2.1 years
June 10, 2020
August 30, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Incidence of patellar crepitus complication
Incidence of patellar crepitus complication (present, absent)
Change from baseline patellar crepitus complication 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
Change of post-operative anterior knee pain
Change from baseline Visual Analog Scale for anterior knee pain at 3 months, 6 months, and 12 months after surgery
Study Arms (2)
Removal of fibrosynovial tissue
EXPERIMENTALRemoval of fibrosynovial tissue in patellar non-resurfacing TKA
Non-removal of fibrosynovial tissue
EXPERIMENTALNon-removal of fibrosynovial tissue in patellar non-resurfacing TKA
Interventions
Remove of fibrosynovial tissue at the superior border of patella
Do not remove of fibrosynovial tissue at the superior border of patella
Eligibility Criteria
You may qualify if:
- Primary osteoarthritis of knee who were scheduled for a primary total knee arthroplasty
You may not qualify if:
- Valgus deformity
- History of inflammatory arthroplathy
- Previous fracture or open surgery on the same knee
- 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.
Department of Orthopaedics, Faculty of Medicine Vajira Hospital, Navamindradhiraj University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
June 10, 2020
First Posted
June 12, 2020
Study Start
June 10, 2020
Primary Completion
July 1, 2022
Study Completion
December 1, 2022
Last Updated
August 31, 2021
Record last verified: 2021-08