Clinical trial NCT04436211: Kinematic- Versus Ligament-balanced Mechanical Alignment in TKA
Official title: A Prospective Randomized Controlled Trial Evaluating Patient Specific Total Knee Arthroplasty Using Kinematic Alignment Versus Ligament-balanced, Mechanical Alignment
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Osteo Arthritis Knee
Lead sponsor: Medical University of Graz
Sponsor class: OTHER
First posted: 2020-06-17
Enrollment: 100
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
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

Brief 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.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change of Range of Motion (ROM) after kinematic vs mechanical aligned TKA
timeFrame: 3; 6; 12 months
measure: Change of Pain after kinematic vs mechanical aligned TKA
timeFrame: 3; 6; 12 months
measure: Change of Function after kinematic vs mechanical aligned TKA (OKS)
timeFrame: 3; 6; 12 months
measure: Change of Function after kinematic vs mechanical aligned TKA (WOMAC)
timeFrame: 3; 6; 12 months
measure: Change of Function after kinematic vs mechanical aligned TKA (KSS)
timeFrame: 3; 6; 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Graz
country: Austria
facility: Medical University of Graz
Study officials:
References: