Total Knee Arthroplasty (TKA)CATNCT05435092
Clinical Correlation of TKA Alignment and Native Knee Anatomy
An observational study of Total Knee Arthroplasty (TKA), run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
Trial summary
Total knee arthroplasty (TKA) is still considered the treatment of choice for painful osteoarthritis. In the last decades neutral mechanical knee alignment in the coronal plane has been considered the gold standard. However, the optimal TKA alignment is still debated. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Total Knee Arthroplasty (TKA)
- What is being tested?
- 3D-reconstruction CT
- Type of treatment
- Surgery or procedure
- How many people
- 75 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Apr 2022to 30 Oct 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- Adult, Older adult
Study population: Patients with knee osteoarthritis who are scheduled for a primary total knee arthroplasty
Who may be able to join
- Age > 18 years
- Diagnosed osteoarthritis of the knee
- Planned primary total knee arthroplasty (cruciate retaining (CR) or posterior stabilizing (PS) designs)
Who cannot join
- Inability to provide informed consent
- Inability to communicate in German, French, Italian or English
- Any previous ipsilateral bony knee procedure prior to TKA
- Planned partial knee arthroplasty, semi- or full-constrained knee prosthesis
- Patients unlikely to attend clinical follow-up (e.g., when living abroad)
- Pregnancy
- Female participants of childbearing potential, not using a medically reliable method of contraception, who do not wish to undergo a pregnancy test prior to exposure to i ionizing radiation
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
University Hospital Basel
Basel, Canton of Basel-City, 4052
About this study
Official title: Influence of Native Knee Anatomy on Alignment and Outcome After Total Knee Arthroplasty CAT - Clinical Correlation of TKA Alignment and Native Knee Alignment
Total knee arthroplasty (TKA) is still considered the treatment of choice for painful osteoarthritis. In the last decades neutral mechanical knee alignment in the coronal plane has been considered the gold standard. However, the optimal TKA alignment is still debated. Today, component rotation measurements on three-dimensional (3D) reconstructed computed tomography (CT) images are considered the gold standard for assessing native preoperative alignment and TKA component position. In this study pre-and postoperative radiographic measurements, functional scores, and biomechanical parameters of patients with knee osteoarthritis will be assessed with the aim to investigate the relationship between deviations of TKA alignment from native preoperative alignment and clinical, functional and biomechanical alignment.
Read the detailed description
Total knee arthroplasty (TKA) is still considered the treatment of choice for painful osteoarthritis resulting in pain and functional improvement. Despite the development of novel prosthetic design and improved outcome, about 20% of patients report persisting pain interfering with their daily activities.Total knee prostheses are aligned in the coronal, sagittal and axial planes during implantation. In the last decades, neutral mechanical knee alignment in the coronal plane has been considered the gold standard. The aim of mechanical alignment in TKA is to achieve a femorotibial joint line that is perpendicular to the mechanical axis of the long leg axis hence correcting any varus-valgus deformity via prosthesis placement with the goal of equally distributing the load between the medial and lateral prosthesis component. However, the optimal TKA alignment is still debated. Traditionally, knee alignment and total knee arthroplasty component position have been assessed using radiographs. However, this method has a low accuracy and reliability because of variation in limb rotation, knee extension deficit, patient positioning, or magnification factors. Component rotation measurements on three-dimensional (3D) reconstructed computed tomography (CT) images have replaced former methods and are now considered the gold standard for assessing native preoperative alignment and TKA component position. In this study pre-and postoperative radiographic measurements, functional scores, and biomechanical parameters of patients with knee osteoarthritis will be assessed with the aim to investigate the relationship between deviations of TKA alignment from native preoperative alignment and clinical, functional and biomechanical alignment.
- Conditions
- Total Knee Arthroplasty (TKA)
- Being tested
- 3D-reconstruction CT
- Keywords
- osteoarthritis, knee protheses, knee replacement, knee alignment, knee pain, 3D-reconstruction Computer Tomography
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3D-reconstruction CTRadiation
Three dimensional CT (3D CT):Method of surface rendition of anatomy by means of a special computer software to capture 3D bone models used to improve the outcomes of Total Knee Arthroplasty (TKA).
| Study group | Role | What they receive |
|---|---|---|
| Patients scheduled for primary TKA | Adult Patients diagnosed with osteoarthritis of the knee and who are scheduled for a primary total knee arthroplasty Receives: Radiation: 3D-reconstruction CT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Deviation of TKA alignment from preoperative native knee alignment in the coronal plane
Primary radiographic endpoints to assess alignment deviations in the coronal plane:
- Whole limb mechanical axis (hip-knee-ankle (HKA) angle, preoperative)
- Native femoral varus/valgus alignment (preoperative)
- Native tibial varus/valgus alignment (preoperative)
- Femoral component varus/valgus alignment
- Tibial component varus/valgus alignment
Measured: 3 months
Secondary outcomes (3)
Evaluation of the Sagittal alignment
Evaluation of the
- Flexion/extension alignment of the femur (preoperative)
- Native tibial posterior slope (preoperative)
- Flexion/extension alignment of the femoral component
- Tibial component posterior slope
Measured: 3 months
Evaluation of the Axial alignment
Evaluation of the
- Native femoral rotation (preoperative)
- Native tibial rotation (preoperative)
- Rotation of the femoral component
- Rotation of the tibial component
- Component mismatch rotation
Measured: 3 months
Assessment of Clinical, functional and biomechanical parameters
Functional scores:
- Oxford Knee Score (OKS)
- Knee Osteoarthritis Outcome Score (KOOS)
- KSS (Knee Society Score)
- NPRS (numeric pain rating scale)
- EQ-5D-5L
Biomechanical parameters:
- Spatiotemporal parameters: walking speed, cadence, stride length, stride duration
- Sagittal plane kinematic parameters: difference in dynamic knee flexion range of motion stance, dynamic knee flexion range of motion gait cycle and dynamic hip flexion range of motion stance between affected and unaffected leg
- Ambulatory joint mechanics parameters: differences in 3-dimensional joint moments and medial and lateral compartment contact forces, tibia rotation, tibia translation and muscle activation patterns
- Muscle strength: Differences in isokinetic muscle strength in knee flexion and knee extension
Local adverse events: persistent or worsening pain; infection; any local event
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2022
- Study start1 Apr 2022
- Primary completion30 Oct 2026 (estimated)
- Study completion30 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Total Knee Arthroplasty (TKA)Studies of the same condition, open and under way.
- More trials run by University Hospital, Basel, SwitzerlandThe 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
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Andreas M. Müller, Prof.Dr.med., Study director, University Hospital of Basel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05435092
- Sponsor's protocol ID
- 2022-00084; mu22Mueller
- Acronym
- CAT
- Status last verified
- Jan 2025
- First submitted
- 15 Jun 2022
- Last updated
- 31 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Native Knee Anatomy on Alignment and Outcome After Total Knee Arthroplasty CAT - Clinical Correlation of TKA Alignment and Native Knee Alignment
- ClinicalTrials.gov ID
- NCT05435092
- Acronym / sponsor ID
- CAT / 2022-00084; mu22Mueller
- Conditions
- Total Knee Arthroplasty (TKA)
- Keywords
- osteoarthritis, knee protheses, knee replacement, knee alignment, knee pain, 3D-reconstruction Computer Tomography
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 75 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Study start
- 1 Apr 2022 (actual)
- Primary completion
- 30 Oct 2026 (estimated)
- Study completion
- 30 Oct 2026 (estimated)
- First posted
- 28 Jun 2022 (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.
Total knee arthroplasty (TKA) is still considered the treatment of choice for painful osteoarthritis. In the last decades neutral mechanical knee alignment in the coronal plane has been considered the gold standard. However, the optimal TKA alignment is still debated. Today, component rotation measurements on three-dimensional (3D) reconstructed computed tomography (CT) images are considered the gold standard for assessing native preoperative alignment and TKA component position. In this study pre-and postoperative radiographic measurements, functional scores, and biomechanical parameters of patients with knee osteoarthritis will be assessed with the aim to investigate the relationship between deviations of TKA alignment from native preoperative alignment and clinical, functional and biomechanical alignment.
Detailed description
Total knee arthroplasty (TKA) is still considered the treatment of choice for painful osteoarthritis resulting in pain and functional improvement. Despite the development of novel prosthetic design and improved outcome, about 20% of patients report persisting pain interfering with their daily activities.Total knee prostheses are aligned in the coronal, sagittal and axial planes during implantation. In the last decades, neutral mechanical knee alignment in the coronal plane has been considered the gold standard. The aim of mechanical alignment in TKA is to achieve a femorotibial joint line that is perpendicular to the mechanical axis of the long leg axis hence correcting any varus-valgus deformity via prosthesis placement with the goal of equally distributing the load between the medial and lateral prosthesis component. However, the optimal TKA alignment is still debated. Traditionally, knee alignment and total knee arthroplasty component position have been assessed using radiographs. However, this method has a low accuracy and reliability because of variation in limb rotation, knee extension deficit, patient positioning, or magnification factors. Component rotation measurements on three-dimensional (3D) reconstructed computed tomography (CT) images have replaced former methods and are now considered the gold standard for assessing native preoperative alignment and TKA component position. In this study pre-and postoperative radiographic measurements, functional scores, and biomechanical parameters of patients with knee osteoarthritis will be assessed with the aim to investigate the relationship between deviations of TKA alignment from native preoperative alignment and clinical, functional and biomechanical alignment.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients scheduled for primary TKA | – | Radiation: 3D-reconstruction CTAdult Patients diagnosed with osteoarthritis of the knee and who are scheduled for a primary total knee arthroplasty |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients with knee osteoarthritis who are scheduled for a primary total knee arthroplasty
Key inclusion criteria (3 listed)
- Age > 18 years
- Diagnosed osteoarthritis of the knee
- Planned primary total knee arthroplasty (cruciate retaining (CR) or posterior stabilizing (PS) designs)
Key exclusion criteria (7 listed)
- Inability to provide informed consent
- Inability to communicate in German, French, Italian or English
- Any previous ipsilateral bony knee procedure prior to TKA
- Planned partial knee arthroplasty, semi- or full-constrained knee prosthesis
- Patients unlikely to attend clinical follow-up (e.g., when living abroad)
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 |
|---|---|---|
| 3D-reconstruction CTThree dimensional CT (3D CT):Method of surface rendition of anatomy by means of a special computer software to capture 3D bone models used to improve the outcomes of Total Knee Arthroplasty (TKA). | Radiation | Patients scheduled for primary TKA |
Primary outcome
Deviation of TKA alignment from preoperative native knee alignment in the coronal plane
Time frame: 3 months
Primary radiographic endpoints to assess alignment deviations in the coronal plane: 1. Whole limb mechanical axis (hip-knee-ankle (HKA) angle, preoperative) 2. Native femoral varus/valgus alignment (preoperative) 3. Native tibial varus/valgus alignment (preoperative) 4. Femoral component varus/valgus alignment 5. Tibial component varus/valgus alignment
3 secondary outcomes
Evaluation of the Sagittal alignment
Time frame: 3 months
Evaluation of the Axial alignment
Time frame: 3 months
Assessment of Clinical, functional and biomechanical parameters
Time frame: 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2025.
- Individual participant dataSharing planned: Undecided
Related trials for Total Knee Arthroplasty (TKA)
RecruitingPhase 3
REGN7508 Versus Apixaban and Enoxaparin for Thromboprophylaxis After Total Knee Arthroplasty in Adults
Venous Thromboembolism (VTE)
RecruitingPhase 3
REGN7508 Versus Acetylsalicylic Acid (ASA) for Venous Thromboprophylaxis After Total Knee Arthroplasty in Adult Participants
Symptomatic Venous Thromboembolism (VTE)
Not yet recruiting
Negative Pressure Wound Therapy Devices in Total Knee Arthroplasty
Wound Surgical, Diabetes
Active, not recruiting
Study to Evaluate the Safety and Effectiveness of the REAL INTELLIGENCE™ CORI™ in Total Knee Arthroplasty (TKA) Procedure
Arthroplasty, Replacement
Not yet recruiting
Application of Perinatal Derivatives in Total Knee Arthroplasty
Total Knee Arthroplasty, Knee Osteoarthristis
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.
Andreas M. Müller, Prof.Dr.med. study director
University Hospital of Basel
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 Total Knee Arthroplasty (TKA), run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
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 3 inclusion and 7 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: under way, not looking for participants, as of the sponsor's last update on 31 Jan 2025. 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 Switzerland. 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?
This study is still under way. Results are not available in the source record yet.
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?
Deviation of TKA alignment from preoperative native knee alignment in the coronal plane (time frame: 3 months). 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 31 Jan 2025.