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
ACL-4114 6x25 mm screw
ACL-4115 6x30 mm screw
ACL-4101 7x20 mm screw
ACL-4102 7x25 mm screw
ACL-4103 7x30 mm screw
ACL-4104 8x20 mm screw
ACL-4105 8x25 mm screw
ACL-4106 8x30 mm screw
ACL-4107 9x20 mm screw
ACL-4108 9x25 mm screw
ACL-4109 9x30 mm screw
ACL-4112 10x30 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
Bone tunnel and graft preparation (2/3)
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
Bone tunnel and graft preparation (3/3)
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
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