Treatment of the Medial Meniscus with the NUsurface® Meniscus Implant.
A Prospective, Multi-Center, Open Label, Non-randomized Study of the NUsurface® Meniscus Implant

Tears of the meniscus are a common source of knee pain. Clinical assessment of
meniscus tears includes non-operative and operative treatment options.
Non-operative treatment includes physical therapy, bracing, rest, activity
modification, analgesics, and inflammatory reduction measures such as icing,
non-steroidal anti-inflammatory medications and occasionally corticosteroid
injections. Non-operative treatment is usually instituted and followed for
approximately six weeks, and patients typically return to full activities after
three months. If the patient does not improve, then surgery must be considered

Operative treatment includes *menisci tears repairs` to relief pain through
tear resection or repair while preserving as much of the meniscus as possible.
Allograft implantation*` with primary indication for the surgery being A
sympyomatic patient having undergone a previous meniscectomy with persistent
pain in the involved compartment and who has failed non-operative treatment.
Other operative treatment are
Meniscal scaffolds and Interpositional devices.
Each of the above treatment options has limitations.

The majority of the aforementioned treatment options are designed primarily to
treat younger patients, most often suffering from traumatic tears rather than
degenerative tears that are most common in people 35 years old and above.
Because of poor regenerative capabilities usually found in these patients,
surgeons are unlikely to choose any of these treatment options. On the other
hand, more aggressive procedures like Unicompartmental Knee Arthroplasty or
Total Knee Arthroplasty may fit in a more severe condition of the cartilage,
e.g., grade 4 OB and relate to older patients (60+), that in many cases, have
three-compartmental disease. Thus, a *treatment gap* can be defined between the
two approaches . Active Implants strongly believes that the NUsurface® Meniscus
Implant can be the preferred treatment that will meet the significant demand
from this patient population in the *treatment gap.*

To evaluate the safety, device-related complications, and performance of the
NUsurface® meniscus implant
as a device for the treatment of patients with degenerative and/or tears of the
medial meniscus. .

This study is a prospective, multi-center, open label, non-randomized study.

All patients fulfilling the criteria for participation in the trial will be
implanted with the NUsurface Meniscus Implant, which received CE Mark approval
in March 2008
The NUsurface devices are available in numerous sizes and are available for
left and right medial meniscus.

The procedure is performed a under anesthesia. The meniscus implant is inserted
during an arthroscopy through a small knee incision (4- 6cm).
The size of the NUsurface implant will be determined based on pre-operatively
X-rays scans trial implants during the intervention.

The burden for the patients is that they have to undergo a more extensive post
operative follow up and rehabilitation progam compared to standard patients
outside this study.

The possible risks of this study are risks associated in general in surgeries,
risks specific for orthopaedic knee implants and add.
The Risks associated with NUsurface®:
The expected life of meniscal implant is difficult to estimate. These
components are made of foreign materials which are placed within the body to
help with the potential restoration of mobility and/or the reduction of pain.
However, because of the many biological, mechanical and physicochemical factors
which affect these devices, the components cannot be expected to withstand the
loads of normal healthy meniscus indefinitely.

The meniscus implant surgery can reduce or eliminate knee pain and improve
mobility of the patient. It could be that the need for more complex procedure
such as a unicompartmental or total knee prosthesis is postponed.