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Completed

NCT Number: NCT05871112

Femoral Rotation and Patellar Positioning After TKA

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

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Key information

Conditions

Knee Osteoarthritis Arthralgia Arthritis Joint Diseases Joint Instability Joint Pain Knee Pain Chronic Musculoskeletal Diseases Neurologic Manifestations Osteoarthritis Osteoarthritis, Knee Pain Patella Disorder Pathological Conditions, Signs and Symptoms Prosthetic Complication Rheumatic Diseases Signs and Symptoms

Age range

60 year–99 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Othopedics and Rehabilitation, Medical University of Warsaw

Warsaw, Mazovian, 04-749, Poland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Use of dynamic tensioner

Other

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

Primary outcomes

  1. 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

  1. Range of motion after TKR

    Time frame: 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

  2. Patient-reported outcome after TKR

    Time frame: 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

  3. Prevalence of anterior knee pain after TKR

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Medical University of Warsaw

Other

Registry information

Official study 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

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
May 23, 2023
Registry last updated
May 23, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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