Osteo Arthritis KneeNCT04436211
Kinematic- Versus Ligament-balanced Mechanical Alignment in TKA
An observational study of Osteo Arthritis Knee, run by Medical University of Graz at 1 site in Austria.
Trial summary
A promising new approach in total knee arthroplasty (TKA) for severe osteoarthritis of the knee joint is the the kinematic aligned procedure (KA). This technique provides prosthesis-positioning based on natural and individual axes of movement. Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Osteo Arthritis Knee
- What is being tested?
- Total Knee Arthroplasty
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- 1 siteAustria
- Study dates
- 15 Feb 2020to 30 Mar 2022
- How long will I take part?
- 5 Years
- 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 50 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Case control study of 50 patients receiving a kinematical aligned TKA and 50 patients receiving a mechanical aligned TKA. In order to ensure comparability, patients are stratified regarding their age and gender before inclusion
Who may be able to join
- Severe osteoarthritis of the knee joint, intended for total knee arthroplasty
Who cannot join
- malalignment with varus of more than 5° or valgus malpositioning, joint instability
Trial locations and contacts
1 site in 1 country.
Austria1 site, 1 recruiting
- Recruiting
Medical University of Graz
Graz, 8044
Patrick Sadoghi, 004361538580971, patrick.sadoghi@medunigraz.at
About this study
Official title: A Prospective Randomized Controlled Trial Evaluating Patient Specific Total Knee Arthroplasty Using Kinematic Alignment Versus Ligament-balanced, Mechanical Alignment
A promising new approach in total knee arthroplasty (TKA) for severe osteoarthritis of the knee joint is the the kinematic aligned procedure (KA). This technique provides prosthesis-positioning based on natural and individual axes of movement.
Although first series have shown satisfying results, further verification by prospective studies and final meta-analyses will be required.
Read more
Thus, the kinematic alignment represents one of the few new developments in TKA.
Provided that patients are willing to participate in the study, patients data are collected preoperatively and during routine follow-up examinations and evaluated prospectively. Patients will receive either a conventionally mechanical aligned arthroplasty or a kinematical aligned TKA, according to a randomized procedure.
The kinematic alignment will be achieved by the use of custom-made cutting-blocks. Therefore, the patients will undergo a computed tomography of the whole leg on the affected side. This is mandatory in order to provide the individually produced cutting blocks.
In order to ensure comparability, patients are stratified regarding their age and gender before inclusion.
Outcome will be measured by the use of standard scoring systems regarding function, pain and ROM (range of motion) three, six and 12 months after surgery.
This study is a monocentric, prospective, randomized and controlled open study.
- Conditions
- Osteo Arthritis Knee
- Being tested
- Total Knee Arthroplasty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Total Knee ArthroplastyProcedure or surgery
The common procedure of Total Knee Arthroplasty is investigated in order to compare the techniques of implantation (kinematic vs mechanical alignment)
| Study group | Role | What they receive |
|---|---|---|
| TKA (mechanical alignment) | Not described Receives: Procedure: Total Knee Arthroplasty | |
| TKA (kinematic alignment) | Not described Receives: Procedure: Total Knee Arthroplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of Range of Motion (ROM) after kinematic vs mechanical aligned TKA
To assess range of motion a Standard Goniometer will be used. Measurements will be obtained after 3, 6, 12 months
Measured: 3; 6; 12 months
Change of Pain after kinematic vs mechanical aligned TKA
The pain will be measured with the Visual Analog Scale (VAS), ranging from 1 to 10. 1 is meaning no pain, 10 is meaning the worst pain imaginable.
Measured: 3; 6; 12 months
Change of Function after kinematic vs mechanical aligned TKA (OKS)
Function of the artificial joint will be assessed by the use of the Oxford Knee Score (OKS). The OKS is a patient reported outcome measure that consists of 12 questions about an individual's activities of daily living and how they have been affected by pain after total knee arthroplasty. All questions are scored from 0-4 where four is the best outcome and total scores range from 0 (worst outcome) to 48 (best outcome).
Measured: 3; 6; 12 months
Change of Function after kinematic vs mechanical aligned TKA (WOMAC)
Function of the artificial joint will be assessed by the use of the Western Ontario and McMaster Universities Arthritis Index Score (WOMAC). The WOMAC survey is comprised of 24 items divided into three subscales: Pain (5 items), stiffness (2 items), and physical function (17 items). Patients are asked a range of questions about their ability to carry out daily activities such as using the stairs, rising from sitting, lying in bed and conducting light or heavy domestic duties. All the items are scored on a scale of 0-4 (lower scores indicate lower levels of symptoms or physical disability). Values are summed up for a combined WOMAC score.
Measured: 3; 6; 12 months
Change of Function after kinematic vs mechanical aligned TKA (KSS)
Function of the artificial joint will be assessed by the use of the Combined Knee Society Score (KSS). The KSS has a "Knee Score" section (7 items) and a "Functional Score" section (3 items). Both sections are scored from 0 to 100 with lower scores being indicative of worse knee conditions and higher scores being indicative of better knee conditions.
Measured: 3; 6; 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2020
- Study start15 Feb 2020
- Primary completion15 Feb 2021 (estimated)
- Study completion30 Mar 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteo Arthritis KneeStudies of the same condition, open and under way.
- 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Medical University of Graz
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04436211
- Sponsor's protocol ID
- 032020
- Status last verified
- Jun 2020
- First submitted
- 1 Apr 2020
- Last updated
- 17 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomized Controlled Trial Evaluating Patient Specific Total Knee Arthroplasty Using Kinematic Alignment Versus Ligament-balanced, Mechanical Alignment
- ClinicalTrials.gov ID
- NCT04436211
- Acronym / sponsor ID
- 032020
- Conditions
- Osteo Arthritis Knee
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Medical University of GrazUniversity, hospital or other
- Study start
- 15 Feb 2020 (actual)
- Primary completion
- 15 Feb 2021 (estimated)
- Study completion
- 30 Mar 2022 (estimated)
- First posted
- 17 Jun 2020 (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.
A promising new approach in total knee arthroplasty (TKA) for severe osteoarthritis of the knee joint is the the kinematic aligned procedure (KA). This technique provides prosthesis-positioning based on natural and individual axes of movement.
Although first series have shown satisfying results, further verification by prospective studies and final meta-analyses will be required.
Thus, the kinematic alignment represents one of the few new developments in TKA.
Provided that patients are willing to participate in the study, patients data are collected preoperatively and during routine follow-up examinations and evaluated prospectively. Patients will receive either a conventionally mechanical aligned arthroplasty or a kinematical aligned TKA, according to a randomized procedure.
The kinematic alignment will be achieved by the use of custom-made cutting-blocks. Therefore, the patients will undergo a computed tomography of the whole leg on the affected side. This is mandatory in order to provide the individually produced cutting blocks.
In order to ensure comparability, patients are stratified regarding their age and gender before inclusion.
Outcome will be measured by the use of standard scoring systems regarding function, pain and ROM (range of motion) three, six and 12 months after surgery.
This study is a monocentric, prospective, randomized and controlled open study.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TKA (mechanical alignment) | – | Procedure: Total Knee Arthroplasty |
| TKA (kinematic alignment) | – | Procedure: Total Knee Arthroplasty |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Case control study of 50 patients receiving a kinematical aligned TKA and 50 patients receiving a mechanical aligned TKA. In order to ensure comparability, patients are stratified regarding their age and gender before inclusion
Key inclusion criteria (1 listed)
- Severe osteoarthritis of the knee joint, intended for total knee arthroplasty
Key exclusion criteria (1 listed)
- malalignment with varus of more than 5° or valgus malpositioning, joint instability
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 |
|---|---|---|
| Total Knee ArthroplastyThe common procedure of Total Knee Arthroplasty is investigated in order to compare the techniques of implantation (kinematic vs mechanical alignment) | Procedure or surgery | TKA (kinematic alignment), TKA (mechanical alignment) |
Primary outcome
Change of Range of Motion (ROM) after kinematic vs mechanical aligned TKA
Time frame: 3; 6; 12 months
To assess range of motion a Standard Goniometer will be used. Measurements will be obtained after 3, 6, 12 months
Change of Pain after kinematic vs mechanical aligned TKA
Time frame: 3; 6; 12 months
The pain will be measured with the Visual Analog Scale (VAS), ranging from 1 to 10. 1 is meaning no pain, 10 is meaning the worst pain imaginable.
Change of Function after kinematic vs mechanical aligned TKA (OKS)
Time frame: 3; 6; 12 months
Function of the artificial joint will be assessed by the use of the Oxford Knee Score (OKS). The OKS is a patient reported outcome measure that consists of 12 questions about an individual's activities of daily living and how they have been affected by pain after total knee arthroplasty. All questions are scored from 0-4 where four is the best outcome and total scores range from 0 (worst outcome) to 48 (best outcome).
Change of Function after kinematic vs mechanical aligned TKA (WOMAC)
Time frame: 3; 6; 12 months
Function of the artificial joint will be assessed by the use of the Western Ontario and McMaster Universities Arthritis Index Score (WOMAC). The WOMAC survey is comprised of 24 items divided into three subscales: Pain (5 items), stiffness (2 items), and physical function (17 items). Patients are asked a range of questions about their ability to carry out daily activities such as using the stairs, rising from sitting, lying in bed and conducting light or heavy domestic duties. All the items are scored on a scale of 0-4 (lower scores indicate lower levels of symptoms or physical disability). Values are summed up for a combined WOMAC score.
Change of Function after kinematic vs mechanical aligned TKA (KSS)
Time frame: 3; 6; 12 months
Function of the artificial joint will be assessed by the use of the Combined Knee Society Score (KSS). The KSS has a "Knee Score" section (7 items) and a "Functional Score" section (3 items). Both sections are scored from 0 to 100 with lower scores being indicative of worse knee conditions and higher scores being indicative of better knee conditions.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2020.
Related trials for Osteo Arthritis Knee
Not yet recruiting
Total Hip Replacement: an Investigation of Robotic-assisted Versus conVentional Surgery and Patient-centred outcomEs
Osteo Arthritis Knee and Hip
Active, not recruiting
SakuraBead Used as Resorbable Embolic for Genicular Artery Embolization
Osteo Arthritis Knee, Joint Diseases
Not yet recruitingPhase 3
A Study to Evaluate Efficacy and Safety of a Single Intra-Articular Injection of HL-01 in the Treatment of Pain in Symptomatic Knee Osteoarthritis
Osteo Arthritis of the Knee
Enrolling by invitationObservational study
Persona SoluTion PPS Femur PMCF
Rhematoid Arthritis, Osteo Arthritis of the Knee
Recruiting
Total Versus Robotic Assisted Unicompartmental Knee Replacement
Osteo Arthritis Knee, Arthritis Knee
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.
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 Osteo Arthritis Knee, run by Medical University of Graz at 1 site in Austria.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 17 Jun 2020. 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 Austria. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Patrick Sadoghi (004331638580971, patrick.sadoghi@medunigraz.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of Range of Motion (ROM) after kinematic vs mechanical aligned TKA (time frame: 3; 6; 12 months). The study lists 5 primary outcomes in all. 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 17 Jun 2020.