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Induced Tension
In order to recreate with anatomical precision the action of the cruciate ligaments, 2 cords in Dacron were fixed to the tibia and threaded into 2 tunnels created in the femur. The free ends of the cords were attached to 2 dynamometers set to measure tension every 15. Fo r ea c h h i n g e, measurements were taken of the distance that gradually separates the articular surfaces using a system of units (0.1mm)

Hin ge

on the cruciate ligaments caused by different types of hinges

G. Pellis, F. Di Cosmo: Tensioni indotte sui legamenti incrociati su diversi tipi di snodo per tutore del ginocchio, Riv. It. Biol. Med., 23 (Suppl. 1 al n. 1-2), 402-4, 2003

Comparison between
a

the tibia-femur reactions, caused by different types of hinges

F. Di Cosmo, G. Pellis: Influenza di diversi tipi di snodo per tutore del ginocchio sui rapporti dinamici fra femore e tibbia, Riv. It. Biol. Med., 23 (Suppl. 1 al n. 1-2), 405-7, 2003

w it

The hinge which determines the movement in the joint

Fasteners to bind femur and tibia

Registered Patent
The Knee Top Joint hinge is protected by patents in Australia, Canada, France, Germany, Japan, Italy, Spain, United Kingdom, United States.

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From observing different types of hinges that are commonly applied to knee braces, it is evident that most of them do not fully respect the physiological rotation-translation movement which is characteristic of this joint the centre of rotation is forced away from lying perpendicular to the point of contact between the 2 articulator surfaces thus causing unnatural movement and abnormal tension to be sustained by the knee capsule as well as the intrinsic and extrinsic ligaments. This does not happen when a hinge is constructed with a variable centre of rotation that respects physiological articulation. This characteristic was demonstrated with the use of a flat plastic replica placed on a saggital plane, that represented the profile of the distal epiphysis of the femur and the proximal epiphysis of the tibia. This plane was then applied to 4 different hinges which varied according to system of rotation adopted:

Awards
fo machine designedcs r ssive gymnasti ate pa used here to simul knee movement.
Gold Medal 28th International Exhibition of Inventions, New Techniques and Products of Geneva, Geneva 2000 Special Mention 28th International Exhibition of Inventions, New Techniques and Products of Geneva, Geneva 2000 IFIA Prize
(International Federation of Inventors Associations)

dynamometer with initial tension equal to 1 Kg (sensibility = 0,01 kg)

dacron cord o (/ 3 mm) which simulates the cruciate ligaments

Technical data
Distance between articular surfaces
[mm] [kg] traction

Hinge with a variable centre of rotation

Hinge with a fixed centre of rotation

Hinge with 2 centres of rotation

Hinge with skipping centre of rotation

28th International Invention Fair, Geneva 2000

Hinge KTJ
[kg] traction

Hinge with a fixed centre of rotation

1st Prize Genia Patent World International Invention Fair, Milan 1997
ACL PCL

ACL PCL

In order, where possible, to render uniform the positioning of the devices with regard to the hinge, the trials were based on the initial centre of rotation according to Niertert. To obtain a correct paragon with real knee movement, we photographed x-rays in lateral projection of a mediumsized adult knee in motion at varying degrees of flexion; 0, 30, 60, 90, 110.

[] flexion

hinge:

fixed centre KTJ

[] flexion

[] flexion

EU Certification
The hinge with a variable centre of rotation reproduces faithfully the natural rotation-translation movement of the knee, and it is suitable for use in rehabilitation mechanisms as it corresponds perfectly with the requirements laid down by the Italian Parliamentary Decree No. 46 of 24 February 1997, concerning EU certification: The devices must be designed and manufactured in such a manner that their use will not compromise the health and the safety of the patient, nor the safety and the well-being of the user. The procedures chosen by the manufacturer in designing and constructing the device must respect the principles of safety and recognise the most up-to-date technological know-how.

X-rays and radiological profiles

Table 1: The distance between the articulator surfaces at different moments of the flexion. The hinge with a fixed centre of rotation determines a marked separation of the articulator surfaces after 35 of flexion. The hinge with a variable centre of rotation guarantees perfect adherence of the articulator surfaces during the entire movement. Table 2 e 3: Tension on the ligaments (cords). With the hinge that offers a variable centre of rotation the tension borne by the ligaments remains low and and constant unlike the tension caused for the hinge with a fixed centre of rotation.

Further consideration
From the trial results, one can assert that the hinge with a variable centre of rotation offers without doubt great advantages with regard to reducing the tension on the cruciate ligaments. It is possible that this reduction of stress on the damaged structures may actually improve the healing/supporting effect of the brace that has this hinge applied to it, leading to greater comfort for the patient. With this in mind Insall (N. Insall, Chirurgia del ginocchio, Verduci editore, Roma 1986, 11,12-13,25), referring to a situation where the centre of rotation is forced to lie away from the line perpendicular to the point of contact between the articulator surfaces, when the knee is unable to carry out the correct rotation-translation, we know that: this condition can come about when either the articulator surfaces or the ligaments, or both, are not inserted into their normal physiological position, or when an immobilising apparatus or an orthopaedic device is applied forcing the articulation to move in an unnatural direction

0
Info
Rivolgersi a:

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www.ktj.it info@ktj.it
info@kneetopjoint.com www.kneetopjoint.com
Tracing the outline on the x-rays at the different angulations, it was possible to obtain a single radiological profile and compare it with the various tracings obtained from the different devices on trial:

Comparision between the joint traction

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and the radiological profile

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1) variable centre KTJ, 2) fixed centre, 3) with 2 centres, 4) skipping centre

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