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

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

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

Study Overview

• Status: Completed
• Conditions: Onlay Patellar Resurfacing Technique; Inlay Patellar Resurfacing Technique; Patellar Resurfacing
• Intervention / Treatment: Procedure: Total knee with onlay patellar resurfacing technique; Procedure: Total knee with inlay patellar resurfacing technique

• Study Type: Interventional
• Enrollment (Actual): 235
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Thailand
  • Bangkok,
    • Dusit, Bangkok,, Thailand, 10300
      • Navamindradhiraj University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Onlay patellar resurfacing technique	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
Experimental: Inlay patellar resurfacing technique	Procedure: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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
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

Collaborators and Investigators

• Sponsor: Navamindradhiraj University

Study record dates

Study Major Dates

• Study Start (Actual): February 20, 2018
• Primary Completion (Actual): February 20, 2020
• Study Completion (Actual): February 20, 2020

Study Registration Dates

• First Submitted: August 27, 2018
• First Submitted That Met QC Criteria: August 27, 2018
• First Posted (Actual): August 28, 2018

Study Record Updates

• Last Update Posted (Actual): April 20, 2021
• Last Update Submitted That Met QC Criteria: April 18, 2021
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: COA 017/2561

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No