Knee OsteoarthritisNCT05871112
Femoral Rotation and Patellar Positioning After TKA
An observational study of Knee Osteoarthritis and Joint Pain, run by Medical University of Warsaw at 1 site in Poland.
Trial summary
Analysis of patellar positioning in the trochlear groove after TKA with and without the use of dynamic tensioner. Read more about this study
- Who is it for?
- Ages 60 to 99 years
- Conditions the study is for
- Knee Osteoarthritis, Joint Pain, Joint Instability
- What is being tested?
- Use of dynamic tensioner
- How many people
- 125 participants
- Where
- 1 sitePoland
- Study dates
- 4 Jan 2021to 29 Aug 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Consecutive series of patients in age over 60 with 3rd/4th grade of Kellgren - Lawrence osteoarthritis scale.
Who may be able to join
- 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
Who cannot join
- varus/valgus/ fixed flexion deformity > 15 degrees
- revision TKA
- prior UKA
Trial locations and contacts
1 site in 1 country.
Poland1 site
Department of Othopedics and Rehabilitation, Medical University of Warsaw
Warsaw, Mazovian, 04-749
About this study
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
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.
- Conditions
- Knee Osteoarthritis, Joint Pain, Joint Instability, Patella Disorder, Knee Pain Chronic, Prosthetic Complication
- Being tested
- Use of dynamic tensioner
- Medical subject headings
- Osteoarthritis, Knee, Arthralgia, Joint Instability
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Use of dynamic tensionerOther
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
| Study group | Role | What they receive |
|---|---|---|
| Patella positioning after TKR + FUZION | Patients who underwent TKR - femoral component rotation established with a use of a dynamic tensioner (FUZION) Receives: Other: Use of dynamic tensioner | |
| Patella positioning after standard TKR | Patients who underwent standard TKR performed with measured resection technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: January 2021 - August 2021
Secondary outcomes (3)
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
Measured: January 2021 - January 2022
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
Measured: January 2021 - January 2022
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
Measured: January 2021 - January 2022
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2023
- Study start4 Jan 2021
- Primary completion29 Aug 2021
- Study completion29 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- More trials run by Medical University of WarsawThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 125 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Warsaw
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Artur Stolarczyk, Medical University of Warsaw
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05871112
- Sponsor's protocol ID
- WarsawMU/FRPP
- Status last verified
- May 2023
- First submitted
- 4 May 2023
- Last updated
- 23 May 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05871112
- Acronym / sponsor ID
- WarsawMU/FRPP
- Conditions
- Knee Osteoarthritis, Joint Pain, Joint Instability, Patella Disorder, Knee Pain Chronic, Prosthetic Complication
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 125 participants (actual)
- Lead sponsor
- Medical University of WarsawUniversity, hospital or other
- Study start
- 4 Jan 2021 (actual)
- Primary completion
- 29 Aug 2021 (actual)
- Study completion
- 29 Aug 2021 (actual)
- First posted
- 23 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Analysis of patellar positioning in the trochlear groove after TKA with and without the 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
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patella positioning after TKR + FUZION | – | Other: Use of dynamic tensionerPatients 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 |
Who may qualify
- Ages
- 60 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Consecutive series of patients in age over 60 with 3rd/4th grade of Kellgren - Lawrence osteoarthritis scale.
Key inclusion criteria (8 listed)
- age over 60
- BMI < 40
- ablity to walk for 10meters
- leg length discrepancy <5mm
- knee flexion > 90 degrees
Key exclusion criteria (3 listed)
- varus/valgus/ fixed flexion deformity > 15 degrees
- revision TKA
- prior UKA
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Use of dynamic tensionerAssessment 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 | Other | Patella positioning after TKR + FUZION |
Primary outcome
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
3 secondary outcomes
Range of motion after TKR
Time frame: January 2021 - January 2022
Patient-reported outcome after TKR
Time frame: January 2021 - January 2022
Prevalence of anterior knee pain after TKR
Time frame: January 2021 - January 2022
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Knee Osteoarthritis and Joint Pain, run by Medical University of Warsaw at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patella positioning in the trochlear groove on computed tomography (CT) after TKR (time frame: January 2021 - August 2021). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 May 2023; AzTrials last refreshed its copy on 8 Nov 2026.