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CompletedNCT05871112Updated May 23, 2023

Femoral Rotation and Patellar Positioning After TKA

An observational study in Knee Osteoarthritis, Joint Pain and Joint Instability, sponsored by Medical University of Warsaw. Completed at 1 site in Poland. Open to participants aged 60 Years to 99 Years. Per ClinicalTrials.gov, last updated 2023-05-23.

Sponsored by Medical University of Warsaw · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
125
Ages
60 Years to 99 Years
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Knee Osteoarthritis
  • Joint Pain
  • Joint Instability
  • Patella Disorder
  • Knee Pain Chronic
  • Prosthetic Complication
03

In context

Arthralgia

273 studies on the registry are indexed under Arthralgia; 41 are open to participants now.

This study's enrollment of 125 is close to the median of 120 across 44 observational studies indexed under Arthralgia.

Browse Arthralgia studies →

Lead sponsor

Medical University of Warsaw is the lead sponsor of 316 studies on the registry; 87 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
60 Years to 99 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Consecutive series of patients in age over 60 with 3rd/4th grade of Kellgren - Lawrence osteoarthritis scale.

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

Exclusion Criteria:

  • varus/valgus/ fixed flexion deformity > 15 degrees
  • revision TKA
  • prior UKA
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
125 participants (actual)
Patient registry
No

Groups and cohorts

  • Patella positioning after TKR + FUZION

    Patients who underwent TKR - femoral component rotation established with a use of a dynamic tensioner (FUZION)

    Other: Use of dynamic tensioner

  • Patella positioning after standard TKR

    Patients who underwent standard TKR performed with measured resection technique

Interventions

  • OtherUse 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

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: January 2021 - August 2021

Secondary outcomes

  1. 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

    Time frame: January 2021 - January 2022

  2. 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

    Time frame: January 2021 - January 2022

  3. 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

    Time frame: January 2021 - January 2022

07

Study locations

1 site
  • Department of Othopedics and Rehabilitation, Medical University of Warsaw
    Warsaw, Mazovian 04-749, Poland
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 23, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05871112
Lead sponsor
Medical University of Warsaw
Responsible party
Artur Stolarczyk (Prof., Medical University of Warsaw) — Principal investigator
First posted
May 23, 2023
Start date
Jan 4, 2021
Primary completion
Aug 29, 2021
Completion
Aug 29, 2021
Last update
May 23, 2023

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2023. You cannot join it, but the record below documents what was studied.

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