Kinematic- Versus Ligament-balanced Mechanical Alignment in TKA

NCT04436211 | Unknown

• 1 other identifier: 032020
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Osteo Arthritis Knee

Outcome Measures

Primary Outcomes (5)

• 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

  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.

  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).

  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.

  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.

  3; 6; 12 months

Study Arms (2)

TKA (mechanical alignment)

Procedure: Total Knee Arthroplasty

TKA (kinematic alignment)

Procedure: Total Knee Arthroplasty

Interventions

Total Knee Arthroplasty PROCEDURE

The common procedure of Total Knee Arthroplasty is investigated in order to compare the techniques of implantation (kinematic vs mechanical alignment)

TKA (kinematic alignment); TKA (mechanical alignment)

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• \- Severe osteoarthritis of the knee joint, intended for total knee arthroplasty

You may not qualify if:

• \- malalignment with varus of more than 5° or valgus malpositioning, joint instability

Sponsors & Collaborators

• Medical University of Graz: lead

Study Sites (1)

Medical University of Graz

Graz, 8044, Austria

RECRUITING

MeSH Terms

Interventions

Arthroplasty, Replacement, Knee

Intervention Hierarchy (Ancestors)

Arthroplasty, Replacement; Arthroplasty; Orthopedic Procedures; Surgical Procedures, Operative; Plastic Surgery Procedures; Prosthesis Implantation

Central Study Contacts

Patrick Sadoghi

CONTACT

004331638580971; patrick.sadoghi@medunigraz.at

Ines Vielgut

CONTACT

004331638581946; ines.vielgut@medunigraz.at

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 1, 2020
• First Posted: June 17, 2020
• Study Start: February 15, 2020
• Primary Completion: February 15, 2021
• Study Completion: March 30, 2022
• Last Updated: June 17, 2020

Record last verified: 2020-06

Locations

AU (1)