Orteq reports knee improvement with Actifit meniscal tissue repair
1 Oct 2010
Orteq Sports Medicine has reported that a two-year study has
found significant pain reduction and functional improvement in patients'
knees repaired with its meniscal scaffold product Actifit.
Actifit is a meniscal scaffold for the treatment of irreparable
partial meniscal tears.
Meniscal tears are the most common injury of the knee, affecting
at least 1.5 million people globally each year. In young patients,
meniscal tears normally occur as a result of sports injuries, with
the most common mechanism involving twisting on a loaded bent knee
with the knee then giving way. The knee's menisci are two half-moon,
wedge-shaped pieces of cartilage that act as a shock absorber
distributing forces evenly between the femur (upper leg) and tibia
(lower leg) in the knee joint.
Developed over the last two decades by leading polymer scientists
and orthopaedic surgeons treating sports injuries, Actifit is
designed to help patients regain an active lifestyle after suffering
a meniscal injury.
The arthroscopically implanted polyurethane scaffold provides a
temporary structure that supports the ingrowth of new tissue to
replace the surgically removed damaged meniscal tissue. In time,
Actifit degrades and is replaced by new functional tissue with
Close-up of the honeycomb structure that
promotes new tissue growth
Professor Rene Verdonk, head of the Department of Orthopaedic
Surgery and Traumatology at the University Hospital in Gent,
Belgium, and lead investigator of the Actifit EU study group, gave
his overall impression of the two year results:
“I am delighted with the two-year results. Young patients
previously hindered by pain have returned to pre-injury activity
levels and can now enjoy a normal life having been treated with
Actifit. The product is safe and reliable, and we had a very low
"It can be clearly seen securely in place on MRI at two years and
the biopsies done of patients at one year showed there is consistent
in-growth of vital new tissue in each biopsy. Actifit appears to be
the next generation solution for the treatment of painful
irreparable partial meniscus tissue loss.”
Dr Eva-Lisa Heinrichs, Chief Medical Officer of Orteq commented:
“The most exciting data from the study is related to the patients’
decreased pain at the same time function has increased. After a
period of rehabilitation, patients can gradually increase their
activity level and return to pre-injury activities.
"In fact, statistically significant improvements were seen in all
clinical scores used in the study (VAS, IKDC, KOOS, and Lysholm),
with the biggest improvement observed in pain reduction and in the
KOOS subscales which assess return to sports and quality of life.
“It has been great to work with the Actifit Study Group, as well
as the specialists in the Orthopaedic, Radiology and Cell Biology
departments at the University Hospital of Gent, Belgium. Their
expertise has been invaluable in completing and analysing the
Actifit EU clinical study data.”
Professor Hans Pässler of the ATOS Klinik in Heidelberg, Germany,
a knee surgeon and key member of the study group, commented: “Having
worked with numerous new technologies for addressing knee injuries,
Actifit seems a most promising breakthrough. Importantly, I find it
easy to use in the operating room and it works very effectively when
used in the right patients.”
Dr Heinz Laprell, from the Lubinus Clinicum in Kiel, Germany and
one of the most experienced users of Actifit, said: “My Actifit
patients have significantly improved. I was very happy to be part of
the Actifit study for this exciting next generation technology for
symptomatic irreparable meniscus tears. I look forward to sharing my
Actifit results at various congresses in the coming months and I
will publish my results separately in addition to the Actifit study
Orteq CEO Dianne Blanco said: “The Actifit 2 year results are
outstanding. We have both excellent patient pain and efficacy
scores. This robust clinical data underpins our belief that Actifit
offers patients an important new option for the treatment of
irreparable partial meniscal tears.”
Actifit has been launched across Europe through a network of
independent distributors and is available in the following
countries: Germany, United Kingdom, Italy, France, Spain, Portugal,
Belgium, Netherlands, Switzerland, Austria, Norway, Sweden, Finland,
Denmark and Greece.
What is a meniscus tear?
The knee joint is the most complex and remarkable joint in the
body. It is capable of withstanding high load and shear stresses.
Integral to the knee's functionality is the meniscus. The knee's
menisci are two half-moon, wedge-shaped pieces of cartilage (the
lateral and medial meniscus), acting as a shock absorber, lubricant
and elastic buffer, distributing forces evenly between the femur
(upper leg) and tibia (lower leg) in the knee joint.
two-thirds of the meniscus is both thin and avascular (has no blood
supply). About 80% of meniscal damage occurs in the avascular area
where successful long-term tissue repair is not possible.
Each year, orthopaedic/sports medicine surgeons treat some 1.5
million meniscal injuries in Europe and the United States alone.
Many of these injuries are originally sports-related from golf,
skiing, soccer or other active pursuits. A sudden twist of the knee
can result in a pinch or tear of the meniscus. At present, if the
tear is in the non-vascularised area, there is only one surgical
option and the damaged tissue is removed by performing a partial
meniscectomy. This leads to a permanent reduction in the
functionality of the knee joint.
When injuries occur in the vascularized area of the meniscus
(about 20% of the time), it is possible to repair the tear by
suturing or using fixation devices. However, treatment fails in
approximately 20% of these cases within two years of the initial
surgery at which stage there is no option but to remove the injured
There is overwhelming clinical evidence that removal of meniscal
tissue leads to a degenerative condition over time. This is followed
by articular cartilage damage, often leading to painful
osteoarthritis (bone and cartilage degeneration) and frequently
results in a total knee replacement. There is a strong demand for
products that will promote the regeneration of new meniscus tissue.