Femoral Rotation and Patellar Positioning After TKA

Completed

• Conditions: Knee Osteoarthritis; Knee Pain Chronic; Joint Pain; Joint Instability; Prosthetic Complication; Patella Disorder
• Interventions: Other: Use of dynamic tensioner

• Registration Number: NCT05871112
• Lead Sponsor: Medical University of Warsaw

Brief Summary

Analysis of patellar positioning in the trochlear groove after TKA with and without the use of dynamic tensioner.

Detailed Description

It appears that by precisely adjusting femoral component rotation and its relation to soft tissues in the area we can achieve better function of the patellofemoral joint and thus reduce the occurrence of anterior knee pain. Achieving proper femoral component rotation is challenging, as the bony landmarks are difficult to identify. This goal may be accomplished by using a dynamic tensioner - a device that intraoperatively measures joint gap stiffness in extension and 90 degrees flexion. This is especially important in knees with high grade arthritis and limb malalignment, where ligaments' and tendons' efficiency is affected.The aim of this study was to analyze patella positioning in the trochlear groove on CT scans of patients undergoing TKR with use of a dynamic tensioner and compare it to the ones undergoing standard measured-resection technique. Secondary outcome was to assess the frequency of anterior knee pain, range of motion and patient-reported outcome 3 and 12 months after the surgery.

Study Timeline

• Study Start: 2021-01-04
• Primary Completion: 2021-08-29
• Study Completion: 2021-08-29
• Status Verified: 2023-05
• Study First Submitted: 2023-05-04
• Study First Submitted QC: 2023-05-13
• Last Update Submitted: 2023-05-13
• Study First Posted: 2023-05-23
• Last Update Posted: 2023-05-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 125

Inclusion Criteria

• age over 60
• BMI < 40
• ablity to walk for 10meters
• leg length discrepancy <5mm
• knee flexion > 90 degrees
• hip extension < 0 degrees
• hip flexion > 90 degrees
• III / IV level of osteoarthritis in Kellgren - Lawrence scale

Exclusion Criteria

• varus/valgus/ fixed flexion deformity > 15 degrees
• revision TKA
• prior UKA

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patella positioning after TKR + FUZION	Use of dynamic tensioner	Patients who underwent TKR - femoral component rotation established with a use of a dynamic tensioner (FUZION)

Primary Outcome Measures

Name	Time	Method
Patella positioning in the trochlear groove on computed tomography (CT) after TKR	January 2021 - August 2021	Analysis of CT scans of patients undergoing TKR in 30 degrees of knee flexion in the days following the procedure

Secondary Outcome Measures

Name	Time	Method
Prevalence of anterior knee pain after TKR	January 2021 - January 2022	Assessment of the frequency of anterior knee pain 3 and 12 months after the surgery in the group with standard TKR and dynamic tensioner TKR
Patient-reported outcome after TKR	January 2021 - January 2022	Assessment of patient-reported outcome 3 and 12 months after the surgery in the group with standard TKR and dynamic tensioner TKR
Range of motion after TKR	January 2021 - January 2022	Assessment of range of motion 3 and 12 months after the surgery in the group with standard TKR and dynamic tensioner TKR

Trial Locations

Locations (1)

Department of Othopedics and Rehabilitation, Medical University of Warsaw; 🇵🇱 Warsaw, Mazovian, Poland