Kinematic- Versus Ligament-balanced Mechanical Alignment in TKA

• Conditions: Osteo Arthritis Knee
• Interventions: Procedure: Total Knee Arthroplasty

• Registration Number: NCT04436211
• Lead Sponsor: Medical University of Graz

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-02-15
• Study First Submitted: 2020-04-01
• Status Verified: 2020-06
• Study First Submitted QC: 2020-06-16
• Last Update Submitted: 2020-06-16
• Study First Posted: 2020-06-17
• Last Update Posted: 2020-06-17
• Primary Completion: 2021-02-15
• Study Completion: 2022-03-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
TKA (kinematic alignment)	Total Knee Arthroplasty	-
TKA (mechanical alignment)	Total Knee Arthroplasty	-

Primary Outcome Measures

Name	Time	Method
Change of Pain after kinematic vs mechanical aligned TKA	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 (KSS)	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.
Change of Function after kinematic vs mechanical aligned TKA (WOMAC)	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 Range of Motion (ROM) after kinematic vs mechanical aligned TKA	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 Function after kinematic vs mechanical aligned TKA (OKS)	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).

Trial Locations

Locations (1)

Medical University of Graz; 🇦🇹 Graz, Austria