Femoral Rotation and Patellar Positioning After TKA
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
1 other identifier
observational
125
1 country
1
Brief Summary
Analysis of patellar positioning in the trochlear groove after TKA with and without the use of dynamic tensioner.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jan 2021
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 4, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 29, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
August 29, 2021
CompletedFirst Submitted
Initial submission to the registry
May 4, 2023
CompletedFirst Posted
Study publicly available on registry
May 23, 2023
CompletedMay 23, 2023
May 1, 2023
8 months
May 4, 2023
May 13, 2023
Conditions
Outcome Measures
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
January 2021 - August 2021
Secondary Outcomes (3)
Range of motion after TKR
January 2021 - January 2022
Patient-reported outcome after TKR
January 2021 - January 2022
Prevalence of anterior knee pain after TKR
January 2021 - January 2022
Study Arms (2)
Patella positioning after TKR + FUZION
Patients who underwent TKR - femoral component rotation established with a use of a dynamic tensioner (FUZION)
Patella positioning after standard TKR
Patients who underwent standard TKR performed with measured resection technique
Interventions
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
Eligibility Criteria
Consecutive series of patients in age over 60 with 3rd/4th grade of Kellgren - Lawrence osteoarthritis scale.
You may qualify if:
- 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
You may not qualify if:
- varus/valgus/ fixed flexion deformity \> 15 degrees
- revision TKA
- prior UKA
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Othopedics and Rehabilitation, Medical University of Warsaw
Warsaw, Mazovian, 04-749, Poland
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Prof.
Study Record Dates
First Submitted
May 4, 2023
First Posted
May 23, 2023
Study Start
January 4, 2021
Primary Completion
August 29, 2021
Study Completion
August 29, 2021
Last Updated
May 23, 2023
Record last verified: 2023-05