Comparison of Post-operative Knee Range of Motion and Functions Between Intraoperative Complete and Incomplete Patellofemoral Articular Contacts in Patients Undergoing Total Knee Arthroplasty

Comparison of Post-operative Knee Range of Motion and Functions Between Intraoperative Complete and Incomplete Patellofemoral Articular Contacts in Patients Undergoing Total Knee Arthroplasty: A Prospective, Randomized Controlled Trial

The purpose of this study is to compare clinical outcome in knee range of motion and functions between intraoperative complete and incomplete patellofemoral articular contacts

Study Overview

• Status: Active, not recruiting
• Conditions: Complete Contact; Incomplete Contact
• Intervention / Treatment: Procedure: Complete patellofemoral articular contact; Procedure: Incomplete patellofemoral articular contact

• Study Type: Interventional
• Enrollment (Anticipated): 60
• 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
• Age 50-80 year

Exclusion Criteria:

• Revision surgery
• Bilateral total knee arthroplasty
• History of patellar fracture
• History of patellar chondromalacia
• 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: Complete contact	Procedure: Complete patellofemoral articular contact; The patellofemoral condition is in constant contact with the femoral trochlea when the knee is bent from 30 to 90 degrees during the No thumb test.
Active Comparator: Incomplete contact	Procedure: Incomplete patellofemoral articular contact; The patellofemoral condition is in no constant contact with the femoral trochlea when the knee is bent from 30 to 90 degrees during the No thumb test.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Knee range of motion (ROM)	Goniometer measure range of motion (minimum 0, maximum 145)	Change from baseline Knee range of motion (ROM) at 3 months, 6 months, and 12 months after surgery
Knee flexion	Goniometer measure knee flexion (minimum 135, maximum 145)	Change from baseline knee flexion at 3 months, 6 months, and 12 months after surgery
Knee extension	Goniometer measure knee extension (minimum -10, maximum 0)	Change from baseline knee extension at 3 months, 6 months, and 12 months after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Navamindradhiraj University
• Investigators: Principal Investigator: Satit Thiengwittayaporn, M.D., satitthh@hotmail.com

Study record dates

Study Major Dates

• Study Start (Actual): April 20, 2021
• Primary Completion (Anticipated): April 1, 2022
• Study Completion (Anticipated): December 1, 2022

Study Registration Dates

• First Submitted: April 21, 2022
• First Submitted That Met QC Criteria: April 21, 2022
• First Posted (Actual): April 27, 2022

Study Record Updates

• Last Update Posted (Actual): April 27, 2022
• Last Update Submitted That Met QC Criteria: April 21, 2022
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: COA 010/2563

Drug and device information, study documents

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