Femoral Rotation and Patellar Positioning After TKA

Knee Osteoarthritis Clinical Trial

Official title:

Establishing Femoral Component Rotation Using a Dynamic Tensioner Does Not Improve Patellar Position After Total Knee Replacement With Use of Anatomic Implants - Matched-cohort Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05871112
• Other study ID #: WarsawMU/FRPP
• Status: Completed
• Start date: January 4, 2021
• Est. completion date: August 29, 2021

Study information

• Verified date: May 2023
• Source: Medical University of Warsaw
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 125
• Est. completion date: August 29, 2021
• Est. primary completion date: August 29, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Arthralgia
• Joint Instability
• Joint Pain
• Knee Osteoarthritis
• Knee Pain Chronic
• Osteoarthritis, Knee

Intervention

Other:
• Use of dynamic tensioner
Assessment of femoral component rotation with a use of a dynamic tensioner in extension and 90 degrees of flexion. The tensioner was put between tibial plane cut and posterior condyles of the femur and tensioned to the same thickness of insert as in the full extension

Locations

Country	Name	City	State
Poland	Department of Othopedics and Rehabilitation, Medical University of Warsaw	Warsaw	Mazovian

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Warsaw

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patella positioning in the trochlear groove on computed tomography (CT) after TKR	Analysis of CT scans of patients undergoing TKR in 30 degrees of knee flexion in the days following the procedure	January 2021 - August 2021
Secondary	Range of motion after TKR	Assessment of range of motion 3 and 12 months after the surgery in the group with standard TKR and dynamic tensioner TKR	January 2021 - January 2022
Secondary	Patient-reported outcome after TKR	Assessment of patient-reported outcome 3 and 12 months after the surgery in the group with standard TKR and dynamic tensioner TKR	January 2021 - January 2022
Secondary	Prevalence of anterior knee pain after TKR	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	January 2021 - January 2022