- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04436211
Kinematic- Versus Ligament-balanced Mechanical Alignment in TKA
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.
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 Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Patrick Sadoghi
- Phone Number: 004331638580971
- Email: patrick.sadoghi@medunigraz.at
Study Contact Backup
- Name: Ines Vielgut
- Phone Number: 004331638581946
- Email: ines.vielgut@medunigraz.at
Study Locations
-
-
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Graz, Austria, 8044
- Recruiting
- Medical University of Graz
-
Contact:
- Patrick Sadoghi
- Phone Number: 004361538580971
- Email: patrick.sadoghi@medunigraz.at
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
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
Description
Inclusion Criteria:
- Severe osteoarthritis of the knee joint, intended for total knee arthroplasty
Exclusion Criteria:
- malalignment with varus of more than 5° or valgus malpositioning, joint instability
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
TKA (mechanical alignment)
|
The common procedure of Total Knee Arthroplasty is investigated in order to compare the techniques of implantation (kinematic vs mechanical alignment)
|
TKA (kinematic alignment)
|
The common procedure of Total Knee Arthroplasty is investigated in order to compare the techniques of implantation (kinematic vs mechanical alignment)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
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.
|
3; 6; 12 months
|
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).
|
3; 6; 12 months
|
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.
|
3; 6; 12 months
|
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.
|
3; 6; 12 months
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 032020
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
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