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Clinical Trials/NCT05871112
NCT05871112
Completed
Not Applicable

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

Medical University of Warsaw1 site in 1 country125 target enrollmentJanuary 4, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Knee Osteoarthritis
Sponsor
Medical University of Warsaw
Enrollment
125
Locations
1
Primary Endpoint
Patella positioning in the trochlear groove on computed tomography (CT) after TKR
Status
Completed
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 4, 2021
End Date
August 29, 2021
Last Updated
2 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Medical University of Warsaw
Responsible Party
Principal Investigator
Principal Investigator

Artur Stolarczyk

Prof.

Medical University of Warsaw

Eligibility Criteria

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

Outcomes

Primary Outcomes

Patella positioning in the trochlear groove on computed tomography (CT) after TKR

Time Frame: 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 Outcomes

  • Prevalence of anterior knee pain after TKR(January 2021 - January 2022)
  • Patient-reported outcome after TKR(January 2021 - January 2022)
  • Range of motion after TKR(January 2021 - January 2022)

Study Sites (1)

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