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

• Sponsor: Navamindradhiraj University (Other)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT05349461
• Collaborator: (none)
• Enrollment: 60
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 19.4
• Patients Per Site Per Month: 3.1

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Complete Contact; Incomplete Contact	Procedure: Complete patellofemoral articular contact; Procedure: Incomplete patellofemoral articular contact	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: 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
• Actual Study Start Date: Apr 20, 2021
• Anticipated Primary Completion Date: Apr 1, 2022
• Anticipated Study Completion Date: Dec 1, 2022

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Knee range of motion (ROM) [Change from baseline Knee range of motion (ROM) at 3 months, 6 months, and 12 months after surgery]

   Goniometer measure range of motion (minimum 0, maximum 145)

2. Knee flexion [Change from baseline knee flexion at 3 months, 6 months, and 12 months after surgery]

   Goniometer measure knee flexion (minimum 135, maximum 145)

3. Knee extension [Change from baseline knee extension at 3 months, 6 months, and 12 months after surgery]

   Goniometer measure knee extension (minimum -10, maximum 0)

Secondary Outcome Measures

1. Knee Society and Knee Society function score [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 (minimum 0, maximum 200)

2. New patellar score [Change from baseline new patellar score at 3 months, 6 months, and 12 months after surgery]

   New patellar score (minimum 0, maximum 30)

3. Oxford knee score [Change from baseline Oxford knee score 3 months, 6 months, and 12 months after surgery]

   Oxford knee score (minimum 0, maximum 48)

4. Prevalence of anterior knee pain ,AKP [Change from baseline Prevalence of anterior knee pain ,AKP 3 months, 6 months, and 12 months after surgery]

   Prevalence of anterior knee pain ,AKP (minimum 0, maximum 10)

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Navamindradhiraj University	Dusit	Bangkok	Thailand	10300

Sponsors and Collaborators

• Navamindradhiraj University

Investigators

• Principal Investigator: Satit Thiengwittayaporn, M.D., [e-mail]

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Satit Thiengwittayaporn, Associate Professor, Navamindradhiraj University
• ClinicalTrials.gov Identifier: NCT05349461
• Other Study ID Numbers: COA 010/2563
• First Posted: Apr 27, 2022
• Last Update Posted: Apr 27, 2022
• Last Verified: Apr 1, 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Apr 27, 2022