Comparison Between the Onlay and Inlay Techniques for Patellar Resurfacing in Posterior Cruciate Ligament-Substituting Total Knee Arthroplasty

Patellar Resurfacing Clinical Trial

Official title:

Comparison Between the Onlay and Inlay Techniques for Patellar Resurfacing in Posterior Cruciate Ligament-Substituting Total Knee Arthroplasty: A Prospective, Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03650426
• Other study ID #: COA 017/2561
• Status: Completed
• Phase: N/A
• Start date: February 20, 2018
• Est. completion date: February 20, 2020

Study information

• Verified date: July 2018
• Source: Navamindradhiraj University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to compare clinical outcome in posterior cruciate ligament-substituting total knee arthroplasty with onlay patellar resurfacing technique and inlay patellar resurfacing technique

Recruitment information / eligibility

• Status: Completed
• Enrollment: 235
• Est. completion date: February 20, 2020
• Est. primary completion date: February 20, 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

• Inlay Patellar Resurfacing Technique
• Onlay Patellar Resurfacing Technique
• Patellar Resurfacing

Intervention

Procedure:
• Total knee with onlay patellar resurfacing technique
The patellar resurfacing technique that the patellar implant is embedded on the patellar bone.The patellar implant is placed on top of a flat tibial osteotomy or cut-surfaced bone
• Total knee with inlay patellar resurfacing technique
The patellar resurfacing technique that the patellar implant is embedded in the patellar bone.The patellar implant is surrounded by a rim of cortical bone and supported by hardened, sclerotic bone

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
Primary	range of motion of knee	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
Primary	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
Primary	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
Primary	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
Primary	Prevalence of anterior knee pain ,AKP	Prevalence of anterior knee pain ,AKP (minimum 0, maximum 10)	Change from baseline Prevalence of anterior knee pain ,AKP 3 months, 6 months, and 12 months after surgery
Primary	Prevalence of patellar crepitus complication	Prevalence of patellar crepitus complication (present, absent)	Change from baseline patellar crepitus complication 3 months, 6 months, and 12 months after surgery