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Neoligaments
A division of Xiros
Springfield House
Whitehouse Lane
Leeds LS19 7UE UK

LAB 142 A

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Tel. +44(0)113 238 7202

Fax. +44(0)113 238 7201
enquiries@neoligaments.com
www.neoligaments.com

Neoligaments, Xiros, Poly-Tape,

Ortho-Tape MPFL System, Jewel ACL,
Rota-Lok, AchilloCordPLUS and Fastlok
are trademarks of Xiros.

Registered in England No.1664824

All rights reserved Neoligaments

2010. Worldwide patents and patents
pending.

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.

Device: Textile implant

Type: General
Size: 5 x 500 mm to
50 x 800 mm
Shape: Flat
Structure: Open
Finish: Standard
Construction: Weave

Device: Textile implant

Type: General
Size: 3 & 400/600 mm
Shape: Flat
Structure: Dense
Finish: Standard
Construction: Weave

Device: Textile implant

Type: Speciality
Size: 5 x 800 mm
Shape: Flat / Tube
Structure: Dense
Finish: Standard
Construction: Weave

Device: Textile implant

Type: Speciality
Size: 10 x 500 mm
Shape: Flat
Structure: Open / Dense
Finish: Standard
Construction: Weave

Device: Textile implant

Type: Speciality
Size: 7 x 710 mm
Shape: Flat / Tube
Structure: Open / Dense
Finish: Plasma
Construction: Weave

Device: Fixation Device

Size: 6 & 8 mm
Shape: N/A
Structure: N/A
Finish: N/A
Construction: Ti

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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

foot & Ankle

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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Textile implants offer

many benefits
The factors that made textile implants so
appealing when they were first introduced
remain as relevant and valid as ever. Their
use for ligament and tendon reconstruction
offers the following benefits:
they remove the need for harvesting
autologous tissues and so eliminate the
pain, muscle deficiency and donor site
morbidity associated with the harvesting
procedure;
where they are used instead of allografts,
the risk of cross infection is eliminated;
their use shortens the surgical procedure
by the time consumed in graft harvesting
and/or preparation;
textile implants offer consistency as they
have uniform properties and dimensions
whereas tissue grafts vary in both
properties and dimensions;
textile implants retain their initial strength,
which is sufficient to permit earlier weight
bearing and earlier return to activities
than do tissue grafts because of the
debilitating necrotic stage they go
through, when they loose much of their
strength that is recovered over a long
period postoperatively;
because textile implants are readily
available in abundance they facilitate
complex reconstruction procedures
where a recipient has sustained multiple
injuries to ligaments in one joint.

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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All our implants are

biologically safe
The process of manufacturing ensures that
the implants are free from contaminants
before they are supplied, sterile with gamma
irradiation, in sealed double blister or pouch
packages. The intended shelf life of the
product has been validated.
The products have been thoroughly
evaluated for biological safety using a range
of tests following ISO 10993-1 Biological
evaluation of medical devices Part 1:
Evaluation and testing within a risk
management process. A quarter of a
century of extensive clinical use with
extremely low levels of reported problems
is evidence of the outstanding safety of
the products.

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The implants possess

high strength so can
allow early rehabilitation

The structure provides

a scaffold for tissue
ingrowth

Our unique plasma

treatment process
speeds cell growth

The textile implants have been thoroughly tested

to determine their initial strength and stiffness
characteristics and their response to simulated
exercise. As an example, the Neoligaments
ESP3000 ACL ligament which is used for young
active patients, has undergone cyclic testing
equivalent to both one and six years of simulated
exercise from implantation. The results
demonstrate that the implant can withstand the
loads placed on it without failure. It also indicates
that the stiffness is similar to that of the natural
ACL so permits correct load transfer to
encourage cell growth.

Neoligaments textile implants are predominantly

of woven construction, comprising parallel
longitudinal (warps) and transverse (weft) fibres
which cross at right angles. The implants
typically possess an open structure that acts
as a scaffold allowing bone and tissue ingrowth.
This new tissue protects the device from
abrasion and, as it matures, it provides
additional strength. This scaffold implant is not
to be confused with the permanent type
implant, such as the Gore-Tex device, which is
designed to last a lifetime with no contribution
from the host tissue or new tissue growth.

Selected textile implants are subjected to

a proprietary low-power cold gas plasma
treatment process. This forms oxidized
chemical groups on the material surface,
turning the standard hydrophobic polyester
into a hydrophilic material.

Strength (N)

This has a dramatic effect, increasing the speed

and extent of cell recruitment and their
adherence to the implant. In vitro studies have
found that tissue ingrowth is approximately four
times faster [Rowland et al. 2003; Tsukazaki et
al. 2003]. Prompt tissue growth has also been
noted clinically via postoperative arthroscopy,
biopsy and transmission electron microscope
studies on scaffold textile implants used for ACL
reconstructions [Sugihara et al. 2006].

Stiffness (N/mm)

4000
3000
2000
1000
0

ACL
Native tissue

ESP3000
Leeds-Keio

Scanning electron microscopy (SEM) showing portions of

control (left) and plasma treated (right) polyester scaffolds
five days after incubation. Note the greater coverage of the
treated materials by synovial stromal cells.

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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.

Both pre-clinical and

clinical studies have
confirmed that the
Neoligaments open
structure provides a
scaffold for tissue
ingrowth

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The natural canine

ACL

8 weeks
postoperatively

24 weeks
postoperatively

32 and 36 weeks
postoperatively

Most salient of
findings

(Top) Morphology has a superficial

vascular network highlighted by the
blue acrylic dye.

(Top) The implant is surrounded with

tissue that is hypervascular.

(Top) Vascularity is greatly reduced in the

new tissue that completely surrounds the
implant seen through the tunnel in the
tibia.

(Top and bottom respectively) The new

tissue has remodelled further into
ligament-like tissue, with even more
reduced cellularity.

For the tissue remodelling procedure to

occur, it is essential that the cells within
the scaffold experience repeated tensile
strain. For this strain to occur, the
ligament must be correctly placed, taut
and securely anchored. Both ligaments
in the pictures have been implanted for
12 weeks. A slack reconstructed ligament
(bottom) does not experience any tensile
strains and so induced tissue would not
remodel as in a taut ligament (top).

(Bottom) Histology shows densely

aligned collagen interspersed with few
cells that are spindle shaped.

(Bottom) The histology shows a random

and hypercellular structure. The cells are
of an oblate morphology.

(Bottom) The tissue is better organized,

with reduced cellularity. Most of the cells
have differentiated into the spindle form
typical of ligament fibroblasts.

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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

slack the tissue was fibrotic and immature.

The process of tissue induction and
remodelling observed in the human model
is identical to that observed in the canine,
except it is much slower.
In another paper [Zaffagnini et al. 2008],
the authors performed a histological and
ultrastructural evaluation of an intact LeedsKeio ACL ligament that had been implanted
for over 20 years. Arthroscopic evaluation of
the intra-articular portion of the Leeds-Keio
ACL ligament revealed a completely
covered implant that was stable during
drawer test, was well fixed at insertion
and stable during palpation.

Mr Kenji Inoeu

Mr Yoshihiro Nakao

Occupation: Professional Freestyle wrestler

Occupation: Professional Freestyle wrestler.

Country:

Japan

Country:

Japan

Surgery:

Bilateral ACL reconstruction using Leeds-Keio ACL

ligament and Poly-Tape.

Surgery:

ACL reconstruction using Leeds-Keio ACL ligament

and Poly-Tape.

Outcome:

At 26 years of age, as a result of injuries sustained in training

sessions and matches, Kenji suffered ACL ligament rupture
in both knees. This resulted in severe knee instability which
prevented him from wrestling. Treatment was undertaken by
Professor Fujikawa at the National Defense Medical School
(NDMS) clinic, initially with the reconstruction of his left knee,
followed by the right knee three months later. Only two
months after the second operation he returned to sport
specific training at the Japanese national training camp for
free style wrestling. Six months and three weeks after the
operation he participated in the All Japan Open Wrestling
Games, winning first prize. Two years and seven months
postoperatively he won the second prize at the All Japan
Wrestling Games. Three years after the operation he won
the bronze medal in the Men's Freestyle 60kg at the 2004
Summer Olympics.

Outcome:

At 22 years of age Yoshihiro sustained an injury to his

right knee joint during training. A ruptured ACL was
diagnosed but was treated conservatively and
training was resumed. A second injury to the joint was
soon sustained, preventing any further training. The
subject was referred to Professor Fujikawa at the NDMS
clinic for ACL reconstruction to the right knee. Two
months after the operation, training was resumed. Seven
months and two weeks postoperatively he participated
in the All Japan wresting games, where he achieved
second place. However, three years after the operation
he again suffered injury to his right knee joint. Following
arthroscopic examination a meniscal tear was observed,
which was repaired accordingly. It was further observed
that the ACL reconstruction was unaffected by the injury,
had good tension and was completely covered with
autogenous tissue giving the appearance of an
original ACL. Yoshihiro was able to resume his
professional career.

Arthroscopic appearance of the tissue induced

around the scaffold implant in a reconstructed ACL
at 12 months postoperatively.

Tissue ingrowth in the Neoligaments

scaffold implants has been reported in
numerous other publications including
extra articular applications such as
medial patellofemoral ligament (MPFL)
reconstruction [Nomura et al. 2005].
Further information can be can be found
in the document Neoligaments
Scientific Articles (LAB 144).

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:

Achilles tendon repair with AchilloCord.

Mr Timm

Outcome:

After three weeks of pain I saw Dr Steel on 5 June who

immediately recognised the problem and quickly
referred me to Darlington Memorial Hospital (DMH)
where I saw Mr Duffy on 7 June. Following an ultrasound
scan, he took the trouble to refer me on to Mr Jennings,
Consultant Orthopaedic Surgeon, North Durham, who
saw me on 8 June and agreed to operate on 12 June.
The ligament reconstruction saved me from weeks in
plaster and meant I was able to enjoy my summer tour
of France. Although I am still having physiotherapy the
operation has been a great success.

Country:

UK

Surgery:

Achilles tendon repair with Poly-Tape.

Outcome:

Mr Timm was initially treated in Scunthorpe with a plaster

cast which resulted in a poor repair. He had difficulty in
working, walking and driving as his Achilles tendon
hadnt healed. The injury was therefore revised by Mr
Jennings, Consultant Orthopaedic Surgeon, North
Durham, with a surgical procedure using the
AchilloCord. Mr Timm commented, Fantastic! Two
weeks after surgery Im walking in normal shoes
without a plaster!

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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.

Tsukazaki S, Kikuchi T, Fujikawa K, Kobayashi T,

Seedhom BB. Comparative study of the covered
area of Leeds-Keio (LK) artificial ligament and
radio frequency generated glow discharge
treated Leeds-Keio (Bio-LK) ligament with
synovial cells. J Long Term Eff Med Implants.
2003;13(4):355-362.
Sugihara A, Fujikawa K, Watanabe H, Murakami
H, Kikuchi T, Tsukazaki S, Aoki Y, Matsunaga M,
Nemoto K. Anterior Cruciate Reconstruction with
Bioactive Leeds- Keio Ligament (LKII): Preliminary
Report. J Long Term Eff Med Implants.
2006;16(1):41-49.
LOWER LIMB
Jones AP, Sidhom S, Sefton G. Long-term
clinical review (10-20 years) after reconstruction
of the anterior cruciate ligament using the LeedsKeio synthetic ligament. J Long Term Eff Med
Implants. 2007;17(1):59-69.
Toms AD, Smith A, White SH. Analysis of the
Leeds-Keio ligament for extensor mechanism
repair: favourable mechanical and functional
outcome. Knee. 2003;10 (2):131-134.
Jennings AG, Sefton GK. Chronic rupture of
tendo Achillis. Long-term results of operative
management using polyester tape. J Bone Joint
Surg. 2002;84B (3):361-3.

Jennings AG, Sefton GK, Newman RJ. Repair of

acute rupture of the Achilles tendon: a new
technique using polyester tape without external
splintage. Ann R Coll Surg Engl. 2004;86(6):
445-8.
Nomura E, Horiuchi Y, Kihara M. A mid-term
followup of medial patellofemoral ligament
reconstruction using an artificial ligament for
recurrent patellar dislocation. Knee.
2000;7(4):211-5.
Usami N, Inokuchi S, Hiraishi E, Miyanaga M,
Waseda A. Clinical application of artificial
ligament for ankle instability--long-term follow-up.
J Long Term Eff Med Implants. 2000;10(4):239-50.
UPPER LIMB
Sanchez M, Cuellar R, Garcia A, Albillos J,
Azofra J. Anterior Stabilization of the Shoulder by
Means of an Artificial Capsular Reinforcement
and Arthroscopy - Part II: Results. J Long Term Eff
Med Implants. 2000;10 (3):199-209.
Nada A, Rogers C, Debnath U. Dacron ligament
augmentation of massive rotator cuff tear. AAOS
75th Annual Meeting Poster Presentations. San
Francisco. 2008:P313.