IMAGISTIC AND MORPHOLOGIC EVALUATION OF THE ARTIFICIAL
MENISCAL IMPLANT
Introduction
The meniscus is a fibercartilagenous structure, which
plays a significant role in maintaining healthy
articular cartilage, lubrication, nutrition, examination as a first-time method in
biomechanics, equal distribution of forces between
femoral condylos and the tibial platou and in the
stability of the knee joint. Also, it is the most
vulnerable part of the knee. Even small lesions can
cause problems in the knee joint by increasing
1,2,3,4
contact stress. Currently, the role of meniscal
lesions in the development and progression of
1,5
osteoarthritis is unanimously accepted. Partial or
total menisctomy may have numerous negative
effects on the joint eventually resulting in
6,7
degenerative changes. Therefore, the primary
intention in the surgical treatment of these lesions is
to preserve meniscus meniscus by practicing the
meniscus suture. This procedure is an elective
option, having only succeeded in lesions in the
vascularized area of the meniscus, in the rest of the
situations, partial or total meniscectomy can’t be
avoided. 1,8,9 However, there are situations where
partial or total meniscectomy can’t be avoided. 10,11
In active population, and between injuries about 15%
this case, in order to slow down the process of
inevitable articulation degeneration, the artificial
implant is an increasingly common
12
alternative.
The symptomatology, clinical examination
and conventional radiology are often insufficient to
be able to put an exact diagnosis, then additional
diagnostic methods are required to lead us to a
correct therapeutic management, including even
conservative therapy.
Until 1980, arthroscopy was considered the
gold standard in the assessment of the knee injuries,
but since then the imagistic evaluation has gained
increasing ground as a non-invasive imaging method
in the therapeutic orientation in terms of the structure
of soft tissue and abnormalities of the bones.
Thus, more surgeons have dropped their
arthroscopic examination and accepted MRI
diagnosis.10,13,14
Methods
A comprehensive search was performed on
PubMed, Medline and Google Scholar databases
using various combinations of the following
keywords: “meniscus implant”, “collagen meniscus
implant”, “Actifit meniscus implant”. In the study
were included the studies evaluating medial or
lateral meniscus, using clinical scale to evaluate the
meniscus before and after the surgery, and which
used MRI to assess the results. We reviewed articles
about Collagen meniscus implant and Actifit
implant, and a comparative study including both of
the implants.
Meniscal tears
The knee is the most exposed joint in the young
are meniscal lesions.15,16 In the stable knee or
associated with a chronic pathology of ACL, more
frequently is affected the medial compartment and
the lateral being associated more often with acute
lesions of ACL.17,18 There are various causes
involved in the occurrence of meniscal lesions. Acute
or traumatic lesions are the result of a forced knee
movement and affect the integrity of the meniscus.
These occur especially in young active
people and may be associated with lesions of the
ligament or joint surface. At the same time, injuries
that do not cause a traumatic one can also occur.
Degenerative or corneal lesions are the result of
changes in cartilage degradation due to the natural
aging process.16,18,19,20 The incidence of meniscal
lesions increases with the age. It was rated 4 times
more frequent the risk of meniscal injury in a group
older than 40 years of age compared to a group of up
to 20 years of age.16
The meniscal lesions can be classified
according to their place of appearance: radial,
horizontal, circumferential and root injuries. The 1/3
middle (red-white area) and 1/3 peripheral (red-red
area) have favorable healing potential compared to
the less vascularized white area.
The radiological examination is extremely
limited in the diagnosis of meniscal lesions. It is
especially used to evaluate unexpected lesions, such
as osteochondrosis. The best non-invasive method of
assessing meniscal lesions and their consequences is
currently imaging through the MRI. It is widely used
to detect knee pathologies and has a low risk of
complications.21
TREATMENT
Meniscal repair
Only 10% of the meniscal lesions have a restorative
indication, the other lesions, located in the white area
of the meniscus, lacking vascular support, are
doomed to failure. In the meniscal reconstruction, we
have to take into account three criteria: the lesion
stability, the integrity of the fragment and the level at
which the lesion is located.11,22,23
Partial or total meniscectomy
In current practice, the most common treatment is the
resection of partial tissue / meniscectomy, most
commonly performed arthroscopically. Although in
most of the lesions meniscectomy can’t be avoided,
this procedure should nevertheless be done as
conservatively, trying to preserve as much as
possible from meniscal tissue. 6,11,24
Meniscal substitution
Currently, two types of artificial implants treat
postmeniscectomy syndrome in Europe: The
collagen meniscus implant (CMI), a type I collagen
fiber structure (purified from the Achilles tendon of
bovines) and Actifit, a synthetic biodegradable
polyurethane structure. They have indisposition in
meniscal lesions that can’t be repaired and in the
treatment of pain, and in order to be successfully
implanted they require an intact vascular edge and
fixation horns.
These implants favor the regeneration of new
meniscal tissue by forming a 3D extracellular matrix
on which the new cells are fixed.2
Collagen meniscus implant
CMI is a type I collagen structure and
glycosaminoglycans (chondroitin and hyaluronic
acid), whose matrix favors neoangiogenesis and
finally the formation of new meniscal tissue.
Samples obtained by biopsy puncture showed new
collagen vessels and fibers and progressive
replacement of the CMI matrix with immature
collagen.2,25,26,27
In 1992 Kevin R. Stone, tested a copolymeric
collagen-based prosthesis to regenerate the meniscal
fibrocartilage in the canine knee joint, and have been
evaluated clinically, histologically and
biochemically, both in vivo and in vitro. The results
showed that a resorbable regeneration template can
be surgically successfully implanted and can support
significant meniscal regeneration, with no
immunologic rejection. As a result of meniscal
regeneration, may be provided stability of the knee,
pain relieve and prevent arthritic changes (as
arthritis, synovitis).12,28,29
Zaffagnini and colleaques implanted the
CMI in patients with irreparable partial lateral
meniscal defects, accompanied by pain and
decreased function. Twenty-four patients underwent
arthroscopic lateral collagen meniscus implantation,
and were evaluated at 6 months and 2 years after the
implantation. At the follow up, 96% of the patients
showed decreased pain and improved knee function.
In addition, the CMI prevents, or at least minimizes,
the degenerative effects of a partial meniscectomy.
The MRI scan showed that the implant size
decreased to a normal meniscus size.30
Bulgheroni et al (2010) evaluate at 2 and 5
years the clinical outcomes and the progression of
osteoarthritis in a study which involved an
arthroscopic placement of the CMI in 34 patients.
The author reported an arthroscopic second look
evaluation just in eight cases, and these patients had
a good to excellent clinical results at 5 years after the
CMI implantation and a good improvement in
stopping degenerative progression on the chondral
surface of the medial meniscus. The MRI evaluation
showed progressively decreasing signal intensity at 2
and 5 years after implantation of the CMI, and a
reduced size of it comparing to the normal meniscus,
but was still not completely similar to a normal
meniscus.31
Grasi et al, in 2014, have done a systematic
review of eleven studies including 396 patients,
evaluating the clinical outcomes of collagen
meniscus implant (CMI) and it’s complications, after
six months to 10 years after surgery. All clinical
outcomes included in the study (Lysholm scale,
visual analogue scale (VAS) for pain, Tegner activity
scale and subjective or objective International Knee
Documentation Comittee (IKDC) scores) showed
significant improvement levels after post-
operative examination, almost in all patients. As a
conclusion, the review states that the CMI reduces
pain and improves the functioning of the knee, also
with low rates of complications and reinteventions.32
Zaffagnini et al. and Monllau et al
evaluated CMI at a minimum follow-up of ten years
and showed improved functional results for several
clinical outcome scores. The studies in which MRI
was used to assess the results, all showed a reduction
in the size of the CMI in the course of the follow-up
period and a very different signal intensity compared
to what is found in the healthy meniscus.33,34
ACTIFIT
Actifit is a synthetic polymerpolycaprolactone and
urethane accelular meniscal scaffold, indicated for
both medial and lateral partial meniscal replacement.
It is slowly degrading (after 5 years) and has good
mechanical properties, is resistant to surgical
procedures, has an increased absorbtion rate which
allows full tissue regeneration. The clinical
application of this meniscal implant started recently,
but despite this, the clinical trials show that is
effective in meniscal replacement.1,2
A study titled “Treatment of Painful,
Irreparable Partial Meniscal Defects with a
Polyurethane Scaffold”1, used a biodegradable
polyurethane scaffold designed to fulfill a
challenging clinical need in the treatment of patients
with painful, irreparable partial meniscal defects.
The treatment objective of the scaffold is to provide
pain relief and restore lost meniscus functionality. It
is already well known that even a minor lesions to
the meniscus can increase contact stress to the
underlying cartilage, therefor can develop and
progress early osteoarthritis due to the meniscal
injury. The polyurethane scaffold, as a porous
structure that encourages tissue ingrowth,
theoretically reduces the risk of osteoarthritis.
In the study were included 44 patients with
irreparable, partial meniscal defects (29 medial and
15 lateral), which were implanted with a
polyurethane scaffold, with a minimum 5-year
follow-up. Patients were clinically and prospectively
evaluated with use of the Knee injury and
Osteoarthritis Outcome Score (KOOS), the
International Knee Documentation Committee
(IKDC) subjective knee evaluation form, and the
visual analog scale (VAS) for pain preoperatively
and at 2- and 5- year follow-up. An independent
orthopedic surgeon performed the clinical follow-up
investigations. Also Magnetic resonance imaging
(MRI) was used to evaluate the implant ant the
cartilage status.
The study reveals that during the follow-up
period, 62.2% of the implants survived. The medial
implants were more successful than the lateral ones.
At final follow-up with a mean of 5.1 years, 66.7%
of the medial scaffolds were still functioning versus
53.8% of the lateral scaffolds. A higher failure rate
for patients with repair in the lateral compartment
was observed, this could be consequent to the higher
stressed observed on the later meniscus than on the
right one. Removal of the scaffold, conversion to a
meniscal transplant, or unicompartmental/total knee
arthroplasty was used as endpoints. The midterm
survival rate of the polyurethane scaffold is favorable
compared with meniscal repair but unfavorable
compared with meniscal transplantation.
The conclusions of the study were that the
polyurethane meniscal implant can improve knee
joint function and significantly reduce pain in
patients with segmental medial meniscus deficiency
up to 5 years after implantation. A stable cartilage
status of the index compartment at 5 years of follow-
up was demonstrated in 46.7% of patients, but there
are still questions about the chondroprotective ability
of the implant. 1
Another study35, accomplished in Belgium,
included fifty-two patients with painful, irreparable
partial meniscal defects (34 medial and 18 lateral,
88% with at least 1 previous surgery), were
implanted with a polyurethane scaffold. At 2 years
after implantation, the clinically improvements were
statistically significant, demonstrating pain and
function improvements, although there were
reported 9 failures, but none of them were considered
to in relationship with the scaffold. Also, the
polyurethane scaffold does not harm the cartilage,
but long-term follow-up controlled studies are
required to confirm a potential chondroprotective
effect.35
Turgay Efe et al, accomplished a study in
Germany, including 20 patients with chronic
segmental medial meniscus deficiency with partial
medial meniscectomy, and who received
arthroscopic implantation of a polyurethane meniscal
implant. The patients were followed-up at 6, 12, 24
and 48 months, clinically (KOOS, KSS, UCLA
activity scale, VAS for pain outcomes scales) and
imagistically (MRI). At follow-up, the clinical
outcomes were significantly improved and the MRI
scan showed no significant changes of the articular
cartilage, with pain reduction and improved knee
functioning, suggesting that the arthroscopic
polyurethane meniscal implant is suitable for chronic
segmental meniscal loss.36
COMPARATIV
The 2 different meniscal scafolds (CMI and Actifit)
have been compared in a study, which included 28
patients who underwent CMI and 25 with an Actifit
scaffold, after they already suffered a partial medial
meniscectomy. All patients were clinically,
histologically and imagistically evaluated, at 6
months, 1 and 2 year. In both groups were showed
clinical improvements, but no statistically significant
improvements were observed intergroups. The MRI
evaluation showed in both groups no progression of
degenerative arthritis, which could mean that the
implant can have a protective effect on articular
cartilage. The histological evaluation showed that in
the CMI group was better developed the fibrous
tissue with blood vessels, and in the Actifit group
appeared avascular cartilaginous features. The
conclusion of the study is that both the CMI and the
Actifit implant are effective in reducing the
symptoms associated with meniscal tear and
increasing the joint functionality.12
TOTAL MENISCUS SUBSTITUTION
Surgeons today are trying to conserve as much as
possible of the damaged meniscus. There are some
lesions that need a complete meniscectomy and for
this patients the best surgical treatment is an allograft
transplant. On long term follow-up periods, up to 20
years, current literature has successfully tried to
prove the stopping of the OA progression. However,
the allograft transplant cannot always be an available
solution. Problems of size matching, disease
transmission and graft availability can occur on the
way. To solve this issues, a total synthetic meniscus
replacement has become a nowadays challenge, but
no anatomically shaped which resists the load forces
in the human knee, has been found.
From the beginning of the 90’s several
biomaterials have been tried to replace the meniscus,
and Messner et al. was the first who published about
the potential of Teflon and Darcon to serve as
permanent meniscal substitutes. But at that time
there wasn’t any access to materials that could
provide the biocompatibility and the properties of a
human meniscus. In time several materials like
porous polyurethane, hyaluronic acid and
polycaprolactone matrix augmented with
circumferential polylactic acid fibers and polyvinyl
alcohol (PVA) hydrogel has been studied, but they
had poor resistance and no benefits on chondral
protection.37
(file:///C:/Users/user/Desktop/pt%20articol/264_20
12_Article_1682.pdf)
MRI
MRI has become increasingly used to diagnose
meniscal tears, for characterizing both the tear
pattern and tissue quality. Being a noninvasive
advanced imaging, it has been shown that MRI
examination has a high accuracy in evaluating the
efficacy of meniscal repair. It has been shown that on
MRI examination, T2-weighted sequences had
higher specificity and accuracy, while proton density
and T1-weighted sequences had higher sensitivity.
MRI of the artificial meniscus implants (CMI
and Actifit), however they have a different
compositions, shows that the shape and the
dimensions are irregular. Both implants have a high
signal intensity on the MRI (higher on T2- weighted
images than on the T1-weighted images), probably
because of the highly porous structure and water
content and absence of a collagen fiber network on
the artificial implant. (1). The scaffold maturation
and the cell and collagen network ingrowth tend to
diminish the hyperintense signal of the implant, but
it never reaches the aspect of a normal
fibrocartilaginous meniscus, which has a low signal
on the MRI.38
In the studies that we reviewed before, the
Collagen Meniscus Implant, was observed on MRI
to have a reduced size over time, with a minimal or
1 5
Aad Dhollander, M. P. (2016). Treatment of Painful,
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absent joint-space narrowing. The signal intensity
progressively decreased over time, although there
was showed a myxoid degeneration in most
implants.
The Actifit scaffold was observed on the MRI
to have a good integration with the native meniscus,
no loosening of sutures or malposition, with tissue
ingrowth.
The biomechanical and architectural features
of the implant can influence the quality of the MRI,
presenting a high variability for each patient, therefor
the quality and regeneration may vary. However, the
MRI is an excellent modality for the imaging of
meniscus replacement strategies.
CONCLUSIONS
Several treatments have been available in the last
decades, but the partial meniscectomy remains the
gold standard treating the meniscus lesions. Meniscal
suture is an option available only for some patients.
For the patients who present a post-meniscectomy
syndrome, have been created some possibilities to
replace the meniscus. A total meniscus substitution
can be achieved with an allograft transplant of
meniscus or with an artificial polycarbonate-
urethane implant (NUsurface). For partial meniscus
substitution CMI and Actifit can be used as an
artificial meniscus implant. The MRI is propitious to
evaluate the postoperative knee and the meniscus
implant.
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37
fkdnsf
38
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