Comparative Study Between Patellar Denervation and Non-patellar Denervation in Total Knee Arthroplasty With Patellar Resurfacing

Patellar Resurfacing Clinical Trial

Official title:

Patellar Denervation in Total Knee Arthroplasty With Patellar Resurfacing to Relieve Postoperative Anterior Knee Pain: a Randomized Control Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03389880
• Other study ID #: COA 147/2560
• Status: Completed
• Phase: N/A
• Start date: December 21, 2017
• Est. completion date: August 20, 2020

Study information

• Verified date: November 2020
• Source: Navamindradhiraj University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to compare the post-operative anterior knee pain (AKP) between patellar denervation and non-patellar denervation in total knee arthroplasty with patellar resurfacing

Recruitment information / eligibility

• Status: Completed
• Enrollment: 241
• Est. completion date: August 20, 2020
• Est. primary completion date: August 15, 2020
• 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

Related Conditions & MeSH terms

• Non-patellar Denervation
• Patellar Denervation
• Patellar Resurfacing

Intervention

Procedure:
• Total knee arthroplasty
A surgical procedure in which parts of the knee joint are replaced with artificial parts (prostheses)
• Patellar denervation
circumpatellar electrocautery with monopolar coagulation diathermy

Locations

Country	Name	City	State
Thailand	Navamindradhiraj University	Dusit	Bangkok,

Sponsors (1)

Lead Sponsor	Collaborator
Navamindradhiraj University

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	range of motion of knee	degree of motion of the knee after surgery	Change from baseline range of motion of knee at 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 (Bartlett score)	New patellar score or Bartlett 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	patellar shift index	The estimation of patellar position relative to the trochear	Change from baseline 3 months, 6 months, and 12 months after surgery
Secondary	prevalence of anterior knee pain	Percent of anterior knee pain	Change from baseline prevalence of anterior knee pain at 3 months, 6 months, and 12 months after surgery
Secondary	activity of daily living	activity of daily living score (minimum 0, maximum 20)	Change from baseline activity of daily living at 3 months, 6 months, and 12 months after surgery
Secondary	post-operative complication	Number and type of post-operative complication	Number and type of post-operative complication at 3 months, 6 months, and 12 months after surgery