Femoral Rotation and Patellar Positioning After TKA

Sponsor
Medical University of Warsaw (Other)
Overall Status
Completed
CT.gov ID
NCT05871112
Collaborator
(none)
125
1
7.8
16.1

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Other: 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 Design

Study Type:
Observational
Actual Enrollment :
125 participants
Observational Model:
Cohort
Time Perspective:
Prospective
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
Actual Study Start Date :
Jan 4, 2021
Actual Primary Completion Date :
Aug 29, 2021
Actual Study Completion Date :
Aug 29, 2021

Arms and Interventions

Arm Intervention/Treatment
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
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

Patella positioning after standard TKR

Patients who underwent standard TKR performed with measured resection technique

Outcome Measures

Primary Outcome Measures

  1. 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

  1. 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

  2. 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

  3. 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

Eligibility Criteria

Criteria

Ages Eligible for Study:
60 Years to 99 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Department of Othopedics and Rehabilitation, Medical University of Warsaw Warsaw Mazovian Poland 04-749

Sponsors and Collaborators

  • Medical University of Warsaw

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Artur Stolarczyk, Prof., Medical University of Warsaw
ClinicalTrials.gov Identifier:
NCT05871112
Other Study ID Numbers:
  • WarsawMU/FRPP
First Posted:
May 23, 2023
Last Update Posted:
May 23, 2023
Last Verified:
May 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 23, 2023