Inion Hexalon™ Interference Screw...Product overview Coloured, biodegradable interference screw...

Inion Hexalon™ Interference Screw Introduction and surgical technique

Version 4, 01-2020

Product overview

Coloured, biodegradable interference screw for ACL/PCL fixation

Single-bundle and double-bundle fixation techniques

Screw diameters 6-10 mm

Screw lengths 20-30 mm

Made of Inion® Polymers with optimal strength and biodegradation characteristics

Retains more than 80 % of initial strength for 12 weeks

Screws are soft in 8 months and totally absorbed in 18 months*

*Järvelä T: Double-bundle anterior cruciate ligament reconstruction using hamstring autografts and bioabsorbable interference screw fixation. J Am Sports Med 36:290-297, 2008.

Features and Benefits

Feature Benefit Inion® Polymer material Tough and strong material with consistent biodegradation

profile, very low rate of tissue reactions (< 1%)

Achieves superior torsional strength and reduced screw breakage risk in comparison to alternative biodegradable screws

Coloured screw Clear visibility during surgery

Screw diameters from 6 to 10 mm

Screw lengths from 20 to 30 mm

Enables single-bundle and double-bundle fixation techniques

Reverse hex screw driver socket Highly resistant to torque reduced risk of screw breakage

Optimised, rounded thread design Provides grip and stability during insertion and once in place

Self-tapping

Suitable to all graft types and limits damage to the graft

Implants and instruments

Art. No Description

ACL-4113 6x20 mm screw













Art. No Description

INS-9200 Screwdriver

INS-9202 24 cm guide wire

INS-9203 38 cm guide wire

INS-9207 RapidNotcher

Implants Instruments

Indications and Contraindications

INDICATIONS (CE mark): The INION HEXALON™ BIODEGRADABLE ACL/PCL SCREW is intended for interference fixation in anterior and posterior cruciate ligament reconstruction using bone-tendon-bone or soft tissue grafts. INDICATIONS (USA): The INION HEXALON™ BIODEGRADABLE ACL/PCL SCREW is intended for soft tissue (including ligament, tendon, and bone-tendon-bone graft) fixation to bone in surgeries of the knee, shoulder, elbow, ankle, foot, hand and wrist where the offered screw sizes are patient appropriate.

CONTRAINDICATIONS: The INION HEXALON™ BIODEGRADABLE ACL/PCL SCREW is contraindicated in case of: • Insufficient quality or quantity of bone for interference screw attachment. • Active or potential infections. • Patient conditions including limited blood supply, chronic disease which causes insufficient quality of bone, and where patient co-operation cannot be guaranteed (e.g. alcoholism, drug abuse).

Surgical technique: Single-bundle reconstruction

Single-bundle reconstruction

Single-incision arthroscopic technique is used with standard AM and anterolateral arthroscopy portals

First the femoral tunnel is drilled through the AM portal with free-hand technique without a guide

The tibial tunnel is drilled

Semitendinosus and gracilis tendons are harvested and quadrupled.

The diameter of the 4-stranded graft is typically 8 mm

The length is 10 mm

The graft is inserted retrograde through the tibial tunnel and fixed with Inion Hexalon™ screws proximally and distally as described later with double bundle technique

Screw size is typically

8x25 mm in the femoral side

8-9x30 mm in the tibial side

Surgical technique: Double-bundle reconstruction

According to:

Järvelä T: Double-bundle versus single-bundle anterior cruciate ligament reconstruction: a prospective, randomized clinical study. Knee Surg Sports Traumatol Arthrosc 15:500-507, 2007.

Järvelä T, Moisala A-S, Sihvonen R, Järvelä S, Kannus P, Järvinen M: Double-bundle anterior cruciate ligament reconstruction using hamstring autografts and bioabsorbable interference screw fixation: prospective, randomized clinical study with 2-year results. Am J Sport Med 36:290-297, 2008

Introduction

The damaged ligament is replaced with two bundles

Posterolateral bundle (double Gracilis graft)

Anteromedial bundle (double Semitendinosus tendon graft)

Allows a more complete restoration of the ACL

Improves especially the rotational stability of the knee

Hypothesised to reduce persistent pivot glide and prevent subsequent arthrosis

Technique requires appropriately sized screws

Advantages of the double-bundle ACL reconstruction procedure More anatomical reconstruction of the ACL

Increased rotational stability

Maximises graft stiffness with true joint line fixation

Arthroscopic portal placement

Artroscopic portals and skin incisions in the right knee

Anterolateral portal

Standard anteromedial portal

Additional anteromedial portal

Skin incision for the harvesting of the hamstring grafts and for drilling of the tibial tunnels

1 2 3

4

Bone tunnel and graft preparation (1/3)

Femoral tunnels

Drill AM femoral tunnel through the AM portal

Freehand technique

As posterior as possible without breaking the posterior wall of the femoral condyle

Diameter typically 7 mm and depth 30 mm

Drill PL femoral tunnel through the AM portal

Freehand technique

Diameter is 6 mm and depth 30 mm

The wall between the AM and PL femoral tunnels at the femoral side needs to be at least 1 to 2 mm.

otherwise inside-out fixation with interference screws is not possible


Graft harvesting

Oblique skin incision is made over the AM surface of the tibia

Semitendinosus and gracilis tendons are harvested with a standard tendon stripper approximately 22 cm above the tibial insertion of the tendons

Diameter of the doubled

semitendinosus graft is approx. 7 mm

gracilis graft approx. 6 mm

Optimal length of graft is 10 cm

minimum length 7 cm


Tibial tunnels

First drill the tibial tunnel for the AM bundle

use tibial drill guide

Position of the AM tibial tunnel is the same as in standard ACL single-bundle technique

Typical diameter 7 mm

PL tibial tunnel has a more medial starting point on the tibial cortex than the standard ACL tibial tunnel

Typical diameter 6 mm

Osseous bridge of approx. 1-2 cm should remain on the tibial cortex between these two tunnels

Graft passage

The PL bundle graft (gracilis tendon) is passed first.

Before the graft is pulled into the femoral bone tunnel, the Inion Hexalon™ Guide Wire should be inserted into the femoral bone tunnel

When the graft is being pulled in place, the guide wire should remain between the graft and the femoral bone tunnel wall, parallel to the long axis of the bone tunnel

This will ensure that the screw be inserted in correct direction

Tunnel notching

Before screw insertion, the tunnel entrance is notched with the cannulated Inion Hexalon™ RapidNotcher (or Inion Hexalon™ Notcher)

For more detailed instructions of how to do notching, see Instructions for Use

It is important to properly notch the bone tunnel entrance before screw insertion

avoids difficulties with screw insertion

reduces risk of screw breakage

Graft fixation (1/2)

Fix the PL bundle by inserting the Inion Hexalon™ screw with the cannulated screwdriver over the guide wire

Screw diameter usually 6 mm and length 25 mm

Remember to insert the screwdriver tip all the way down to the bottom of the screw socket before screw insertion

Also remember to align the guide wire, screwdriver and the screw parallel to the long axis of the bone tunnel before screw insertion

Graft fixation (2/2)

Pass and fix the AM bundle (double semitendinosus tendon graft) with the same technique as the PL femoral graft

AM femoral side screw diameter usually 7 mm and length 25 mm

On the tibial side, the PL and AM bundles are tensioned by hand and fixed with Inion Hexalon™ screws

The tibial PL tunnel screw is typically 7x30 mm

The tibial AM tunnel screw is typically 8x30 mm

Screws are inserted as close to the joint line as possible (outside in)

Additional fixation is made with non-degradable sutures coming from each graft to tie them together ove the cortical bone bridge between the tibial tunnels.

Postoperative rehabilitation

Immediate full weight bearing and full range of motion is permitted

Crutches are used for 3-4 weeks

No rehabilitation brace

Closed-chain exercises are started immediately postoperatively

Cycling is permitted with an ergometer bicycle at 4 weeks, running at 3 months postoperatively

Pivoting sports permitted at 6 months postoperatively, provided that the patient has regained full functional stability

If meniscal repair is performed at the same operation, the range of motion of the knee is allowed 0-90° for the first 6 weeks. Otherwise rehabilitation regime is as described above

Summary of typical screw sizes

Bundle/ Tunnel Screw size

PL femoral 6x25 mm (ACL-4114)

AM femoral 7x25 mm (ACL-4102)

PL tibial 7x30 mm (ACL-4103)

AM tibial 8x30 mm (ACL-4106)

Bundle/ Tunnel Screw size

Femoral 8x25 mm (ACL-4105)

Tibial 8x30 mm (ACL-4106) OR 9x30 mm (ACL-4109)

Double-bundle Single-bundle

Inion Hexalon™ Interference Screw...Product overview Coloured, biodegradable interference screw...

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