Incidence of Patellar Crepitus in Removal and Non-removal of Fibrosynovial Tissue at Superior Pole of Patella

Not Applicable

• Conditions: Removal of Fibrosynovial Tissue; Non-removal of Fibrosynovial Tissue; Patellar Non-resurfacing
• Interventions: Procedure: Non-removal of fibrosynovial tissue; Procedure: Removal of fibrosynovial tissue

• Registration Number: NCT04429997
• Lead Sponsor: Navamindradhiraj University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-06-10
• Study First Submitted: 2020-06-10
• Study First Submitted QC: 2020-06-10
• Study First Posted: 2020-06-12
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-30
• Last Update Posted: 2021-08-31
• Primary Completion: 2022-07
• Study Completion: 2022-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 138

Inclusion Criteria

• Primary osteoarthritis of knee who were scheduled for a primary total knee arthroplasty

Exclusion Criteria

• Valgus deformity
• History of inflammatory arthroplathy
• Previous fracture or open surgery on the same knee
• History of patellar instability

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Non-removal of fibrosynovial tissue	Non-removal of fibrosynovial tissue	Non-removal of fibrosynovial tissue in patellar non-resurfacing TKA
Removal of fibrosynovial tissue	Removal of fibrosynovial tissue	Removal of fibrosynovial tissue in patellar non-resurfacing TKA

Primary Outcome Measures

Name	Time	Method
Incidence of patellar crepitus complication	Change from baseline patellar crepitus complication 3 months, 6 months, and 12 months after surgery	Incidence of patellar crepitus complication (present, absent)

Secondary Outcome Measures

Name	Time	Method
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	Visual Analog Scale for anterior knee pain (minimum 0, maximum 10) Do higher values represent a worse outcome
Oxford knee score	Change from baseline Oxford knee score 3 months, 6 months, and 12 months after surgery	Oxford knee score (minimum 0, maximum 48)
New patellar score	Change from baseline new patellar score at 3 months, 6 months, and 12 months after surgery	New patellar score (minimum 0, maximum 30)
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	Knee Society and Knee Society function score (minimum 0, maximum 200)

Trial Locations

Locations (1)

Navamindradhiraj University; 🇹🇭 Dusit, Bangkok,, Thailand