Non-removal of Fibrosynovial Tissue Clinical Trial
Official title:
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
| Verified date | August 2021 |
| Source | Navamindradhiraj University |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Active, not recruiting |
| Enrollment | 138 |
| Est. completion date | December 2022 |
| Est. primary completion date | July 2022 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | N/A and older |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| Thailand | Navamindradhiraj University | Dusit | Bangkok, |
| Lead Sponsor | Collaborator |
|---|---|
| Navamindradhiraj University |
Thailand,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | Knee Society and Knee Society function score | Knee Society and Knee Society function score (minimum 0, maximum 200) | Change from baseline Knee Society and Knee Society function score at 3 months, 6 months, and 12 months after surgery | |
| Secondary | New patellar score | New patellar score (minimum 0, maximum 30) | Change from baseline new patellar score at 3 months, 6 months, and 12 months after surgery | |
| Secondary | Oxford knee score | Oxford knee score (minimum 0, maximum 48) | Change from baseline Oxford knee score 3 months, 6 months, and 12 months after surgery | |
| Secondary | Change of post-operative anterior knee pain | Visual Analog Scale for anterior knee pain (minimum 0, maximum 10) Do higher values represent a worse outcome | Change from baseline Visual Analog Scale for anterior knee pain at 3 months, 6 months, and 12 months after surgery |