Neoligaments JewelACL Instrucciones De Uso página 3

English
Ordering Information (supplied sterile)
102-6003 JewelACL™, 7 mm ID x 710 mm
Description
The JewelACL is a polyester prosthesis for anterior
cruciate ligament (ACL) reconstruction. It is matched
in tensile strength to the semitendinosus hamstring
tendon, which is typically 1200 N, and can be used
with or without an additional tissue graft in either partial
or total tissue sparing ACL reconstruction procedures.
Material Specifications
The JewelACL is made from polyethylene terephthalate
(polyester). The polyester has been subjected to
a proprietary gas plasma process that modifies its
surface properties, making it hydrophilic, without
significantly altering the physical characteristics of the
bulk material. This increases the speed and extent of
cell recruitment and adhesion and the remodelling of
the tissue into a "neoligament".
Fixation
The JewelACL must only be secured using the
approved fixation devices detailed below. When using
these devices it is critical to follow the instructions for
use supplied with them and to observe the conditions
and necessary adjustments stated in the notes below.
Femoral Fixation
EndoButton CL Ultra (Smith & Nephew) OR
®
TransFix (Arthrex)
®
Tibial Fixation with a Screw
Interference Screw, 7 mm x 30 mm (Medgal) 5.5 mm
bone tunnel, OR
RCI Screw , 7 mm x 25 mm (Smith & Nephew)
®
6.5 mm bone tunnel
Tibial Fixation with a Screw and Tissue Graft
Size the bone tunnel to match the overall graft diameter
and use a larger diameter screw. For example:
Graft diameter 6.5 mm
Tunnel diameter 6.5 mm
Screw diameter 8.0 mm
This applies to normal bone density with a typical graft
diameter. At the discretion of the surgeon the screw
diameter may be increased in cases encountering soft
bone in order to obtain secure fixation.
Intended Use
The JewelACL is intended to be used for reconstruction
of the anterior cruciate ligament.
Indications
The JewelACL is indicated for all patients requiring
ACL reconstruction that are not excluded by the
contraindications listed below.
Contraindications
• Known hypersensitivity to implant materials. If the
patient is suspected of having any foreign body
sensitivity, appropriate tests should be made prior
to implantation.
• Infections, or any structural or pathological
condition of the bone or soft tissue that would be
expected to impair healing or secure fixation.
• Patients unable or unwilling to restrict activities
to prescribed levels or follow a rehabilitation
programme during the healing period.
• The JewelACL may not be suitable for skeletally
immature patients as it will not elongate and so
must not bridge, disturb, or disrupt the growth
plate.
• Patients for whom it is not possible to bend the
knee to at least 90º as it will not be possible to
reach the correct position for drilling the bone
tunnels.
Warnings
• The device is provided sterile and remains so
unless the packaging is damaged or opened. DO
NOT RESTERILIZE.
• The device is for single use only as it would be
damaged by reprocessing. Do not use after
the expiration date. Discard any open, unused
product.
• The surgeon must be thoroughly familiar with
these instructions and the recommended surgical
procedure before using the device.
• The general principles of patient selection
and sound surgical judgement apply to the
reconstruction procedure.
• There are no data to support the use of the
JewelACL in pregnant and breast-feeding women.
MRI Safety Information
The JewelACL is MR safe (i.e. an item that poses no
known hazards in all MR environments).
Precautions
• Inspect the device, packaging and labelling prior
to use and do not use if damaged. Contact the
Neoligaments Sales Department if the package
has been opened or altered.
• Correct isometric placement is crucial to the
successful outcome of the reconstruction. Failure
to place the ligament bone tunnels correctly is
likely to lead to an unsatisfactory outcome. The