Femoral Rotation and Patellar Positioning After TKA
May 13, 2023 updated by: Artur Stolarczyk, Medical University of Warsaw
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
Analysis of patellar positioning in the trochlear groove after TKA with and without the use of dynamic tensioner.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Observational
Enrollment (Actual)
125
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Mazovian
-
Warsaw, Mazovian, Poland, 04-749
- Department of Othopedics and Rehabilitation, Medical University of Warsaw
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
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.
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Patella positioning after TKR + FUZION
Patients who underwent TKR - femoral component rotation established with a use of a dynamic tensioner (FUZION)
|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
January 2021 - August 2021
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
January 2021 - January 2022
|
|
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
|
January 2021 - January 2022
|
|
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
|
January 2021 - January 2022
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 4, 2021
Primary Completion (Actual)
August 29, 2021
Study Completion (Actual)
August 29, 2021
Study Registration Dates
First Submitted
May 4, 2023
First Submitted That Met QC Criteria
May 13, 2023
First Posted (Actual)
May 23, 2023
Study Record Updates
Last Update Posted (Actual)
May 23, 2023
Last Update Submitted That Met QC Criteria
May 13, 2023
Last Verified
May 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- WarsawMU/FRPP
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.