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Neoligaments
A division of Xiros
Springfield House
Whitehouse Lane
Leeds LS19 7UE UK
LAB 142 A
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Implants for
Ligament & Tendon
Reconstruction
The design and science behind why they work
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Product Portfolio
The Neoligaments product portfolio
comprises textile implants and
fixation devices. The textile implants
fall into two types: general devices
and speciality devices.
Textile Implants
General devices
The general devices are intended to be used for any
soft tissue approximation. They are available in a range
of standard sizes, between 3 mm and 50 mm wide and
in various lengths. They are available in two shapes: a
single thickness flat tape, or a double thickness (tube).
Each of these may have an open or dense structure.
The strength increases with width to improve the
resistance to failure. The surgeon can select from this
range the device best suited to the repair. Such devices
include the Poly-Tape and Ortho-Tape.
Fixation Devices
General
Poly-Tape
Speciality
Ortho-Tape
AchilloCordPlus
Rota-Lok
JewelACL
FastLok
Speciality devices
Speciality devices are those which have been optimized
to repair a particular tissue. These include the RotaLok, for reconstruction of massive rotator cuff tears,
and JewelACL, for anterior cruciate ligament (ACL)
reconstruction. These devices typically include a mix of
specific structural features such as sections of open
and dense weave, pockets, or cords for pulling the
implant through bone tunnels. The dimensions,
strength and stiffness characteristics of these devices
are biomechanically designed to suit their intended
application. This ensures the implant can withstand
the load placed on it without failure and permits
correct load transfer to encourage tissue ingrowth
and remodelling.
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Applications
The Neoligaments product portfolio is versatile
and surgeons have used these implants for repair
or reconstruction of many ligaments and tendons
in the joints of both the lower and upper limbs.
Knee
Shoulder
Hip
Rotator cuff
Acromioclavicular joint and
coracoclavicular ligaments
Antero-inferior gleno-humeral
ligament capsular reinforcement
Augmented subscapularis
muscle transposition for rotator
cuff repair during shoulder
arthroplasty*
Iliofemoral ligament*
Reattaching muscles to a tumour
endoprosthesis*
Patellar tendon
Quadriceps tendon
Anterior cruciate ligament (ACL)
Posterior cruciate ligament
(PCL)*
Medial patellofemoral ligament
(MPFL)
Tibial/femoral fixation of ACL/PCL
grafts*
Medial collateral ligament (MCL)*
Lateral collateral ligament (LCL)*
Popliteal tendon*
Reattaching muscles to a tumour
endoprosthesis*
* Neoligaments has not clinically evaluated those procedures marked with an asterisk and does not currently supply a surgical technique
manual for them. However, the use of the Poly-Tape for such procedures has been reported at conferences and in medical journals.
Achilles tendon
Peroneal tendon stabilization
Lateral ankle ligament*
Repairing fail foot*
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Manufactured from
polyester, a material
with many years of
implant history
The Neoligaments textile implants are
manufactured in-house, at dedicated
manufacturing sites in the UK, from
polyethylene terephthalate (PET) which is
commonly know as polyester. Polyester has
mechanical properties which, with careful
design, can match the strength and stiffness
of natural tissue. It is therefore ideal for the
manufacture of implants for ligaments
and tendons.
This nonabsorbable material is one of the
most common polymers to be used in
medical implants. For more than 40 years
it has been utilized in the manufacture of
arterial grafts and aortic implants. It has
been used for fixation of ACL grafts
(EndoButton Continuous Loop, Smith
& Nephew) for over 10 years, for
ligaments for over 25 years and for
sutures for over 70 years.
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Strength (N)
Stiffness (N/mm)
4000
3000
2000
1000
0
ACL
Native tissue
ESP3000
Leeds-Keio
Pre-clinical studies
Numerous studies have reported on
induction and remodelling processes of
tissue ingrowth into the structure of the
scaffold implant. Of these, two were
undertaken in a canine model [Fujikawa et
al. 1993]. The figures (right) briefly describe
the salient findings of the first study, which
was undertaken on 13 animals and spanned
36 weeks. The second investigated different
surgical techniques in a series of 60
animals. Of particular interest are the
findings concerned with the ligament-bone
junction, the morphology and histology of
which revealed an abundance of Sharpeys
fibres that adjoined the newly formed soft
tissue to the bone. Fibrocartilage with
chondrocytes was also observed and there
was evidence of the four layers commonly
found in the normal ligamentous and
tendinous junction to the bone.
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8 weeks
postoperatively
24 weeks
postoperatively
32 and 36 weeks
postoperatively
Most salient of
findings
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Case Studies
Clinical studies
An arthroscopic study [Fujikawa et al. 1989]
reported on 42 recipients of the Leeds-Keio
ACL ligament, who had a mean age at
operation of 23.5 years, and were followed
up at 3 to 24 months postoperatively.
Biopsies on 19 of the implants were taken
at 3, 6, 12 and 18 months. At 3 months,
arthroscopy showed the implant covered
in tissue with a dense vascular network.
By 6 months there were synovial cords
running along the length of the implant.
By 8 months the tibial insertion had
remodelled and become broader and fan
shaped. The implant was tight throughout
the range of motion (ROM). By 12 months
the reconstruction appeared like the natural
ligament in terms of shape and thickness,
with reduced vascular network on its
surface. By 12 to 18 months the histology
revealed large quantities of
parallel collagenous fibres running in the
direction of loading. However, more cells
were present than would be found in normal
ligamentous tissue. At 18 to 24 months
the reconstruction could be mistaken for
a natural ligament. Where an implant was
Mr Kenji Inoeu
Mr Yoshihiro Nakao
Country:
Japan
Country:
Japan
Surgery:
Surgery:
Outcome:
Outcome:
Mr Andrew Young
The histology of a reconstructed ACL at 12 months
postoperatively. It shows a crimped structure typical
of normal collagen, but with a looser and somewhat
hypercellular structure. The orientation of the fibres
is longitudinal and parallel.
Country:
UK
Surgery:
Mr Timm
Outcome:
Country:
UK
Surgery:
Outcome:
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References
HISTOLOGY
Fujikawa K, Seedhom BB, Matsumoto H,
Kawakubo M,Otani T. The Leeds-Keio ligament.
In: Strover A, editor. Intra-articular reconstruction
of the anterior cruciate ligament. London:
Butterworth Heinemann, 1993:173-207.
Fujikawa K, Iseki F, Seedhom BB. Arthroscopy
after anterior cruciate reconstruction with the
Leeds-Keio ligament. J Bone Joint Surg Br.
1989;71(4):566-570.
Zaffagnini S, Marcheggiani Muccioli GM,
Chatrath V, Bondi A, De Pasquale V, Martini D,
Bacchelli B, Marcacci M. Histological and
ultrastructural evaluation of Leeds- Keio ligament
20 years after implant: a case report. Knee Surg
Sports Traumatol Arthrosc. 2008;16(11):10261029.
Nomura E, Inoue M, Sugiura H. Histological
evaluation of medial patellofemoral ligament
reconstructed using th Leeds-Keio ligament
prosthesis. Biomaterials. 2005;26 (15):2663-2670.
PLASMA TREATMENT
Rowland JR, Tsukazaki S, Kikuchi T, Fujikawa K,
Kearney J, Lomas R, Wood E, Seedhom BB.
Radiofrequency-generated glow discharge
treatment: potential benefits for polyester
ligaments. J Orthop Sci.
2003;8(2):198-206.