Health conditions (Datenquelle: WHO)

Patients must display 1-2 symptomatic, focal cartilage lesion grade IIIIV(according to the grading by the International Cartilage RepairSociety (ICRS)) from 2 to 8 cm2 on the femoral condyle and/or thetrochlea, have to be between 18-65 years old and must consent in oraland written manner in order to be enrolled in the study.;Therapeutic area: Not possible to specify

Interventions (Datenquelle: WHO)

Product Name: N-TEC
Pharmaceutical Form: Implant

Product Name: N-CAM
Pharmaceutical Form: Implant

Inclusion/Exclusion Criteria (Datenquelle: WHO)

Inclusion criteria:
Patient is =18 and =65 years old at time of screening.
• Patient has a localized articular cartilage defect of the femoral
condyle and/or the trochlea of the knee. 2 localized cartilage defects
are accepted if the total defect size is = 8 cm2, both cartilage defects
are located at the femoral condyle and/or the trochlea and both
cartilage defects are to be treated with N-CAM or N-TEC.
• Patient has a defect of grade 3 or 4 according to the ICRS
classification.
• Patient has a defect size =2 and =8 cm2 as assessed by
MRI/arthroscopy.
• Patient has an opposite intact (=ICRS Grade 1 ) articulating joint
surface (no kissing lesions).
• Patient has an intact meniscus (maximum 1/3-resection).
• Patient has a stable knee joint or sufficiently reconstructed
ligaments. If not, ligament repair has to be done during the operation
or within 6 weeks of the planned cartilage treatment.
• Patient has a maximum baseline score of 75/100 in the KOOS
subjective knee evaluation.
• Patient is willing and able to give written informed consent to
participate in the study and to comply with all study requirements,
including attending all follow-up visits and assessments and to
complete postoperative rehabilitation regimen.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 108
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
• Patient is unable to understand the patient information
• Patient is unable to undergo magnetic resonance imaging (MRI) or
is sensitive to gadolinium
• Patient has had prior surgical treatment of the target knee within 12
months using mosaicplasty and/or microfracture (Note: prior
diagnostic arthroscopy with debridement and lavage are acceptable
within 12 months). Anterior cruciate ligament repair is accepted, if the
target knee is stable or a primary ACL reconstruction is performed
within 6 weeks of the planned cartilage treatment.
• Patient has an onset of symptoms of > 5 years.
• Patient has a relevant meniscus tear. Partial meniscal removal
allowed, if not exceeding 1/3. Meniscus suture is not allowed in
parallel, but if successful, cartilage treatment might be added 12
months later.
• Patient has radiologically apparent degenerative joint disease in the
target knee as determined by Kellgren and Lawrence grade >2.
• Patient has evidence of joint disease e.g. chronic inflammatory
arthritis, and/or infectious arthritis.
• Patient has an unstable knee joint or insufficiently reconstructed
ligaments. If ligament repair is necessary, the repair has to be
performed during the operation or within 6 weeks of the planned
cartilage treatment.
• Patient has malalignment (no valgus- or varus-deformity) in the
target knee = 5°. In suspected cases, the mechanical axis must be
established radiographically through complete leg imaging during
standing and in a.p. or rather p.a. projection. If alignment surgery is
necessary, surgery has to be performed within 6 weeks of the planned
cartilage treatment.
• Patient has an osteochondral defect (defined as bony substancedefect of >3mm depth). Bone marrow edema is allowed.
• Any concomitant painful or disabling disease of the spine, hips, or
lower limbs that would interfere with evaluation of the afflicted knee.
• Patient has a known systemic connective tissue disease.
• Patient has a known autoimmune disease.
• Patient has a known immunological suppressive disorder or is taking
immunosuppressives.
• Patient is currently systemically or intra-articularly taking steroids
and/or has used steroids within the 30 days prior to the planned
treatment.
• The patient has a known history of HIV/AIDS. (Protection of staff)
• The patient has a known history of Treponema pallidum (syphilis).
(Protection of staff)
• The patient has an active hepatitis B or C infection with verified
antigens. Patients with a cured hepatitis B or C infection and/or
verified antibodies are not excluded. (Protection of staff)
• The patient has at the site of surgery an active systemic or local
microbial infection, eczematization or inflammable skin alterations
(including Protozoonosis: Babesiosis, Trypanosomiasis (e.g. Chagas-
Disease), Leishmaniasis, persistent bacterial infections, such as
Brucellosis, spotted and typhus fever, other Rickettsiosis, Leprosy,
Recurrent Fever, Melioidosis or Tularaemia).
• Patient has a known history of cancer.
• Patient has a known history of primary hyperparathyroidism,
hyperthyroidism, reduced kidney function (GFR > 80 ml/min), or prior
pathological fractures, independent of the genesis.
• Patient has any degenerative muscular, vascular or neurological
condition that would interfere with evaluation of outcome measuresincluding but not limited to Parkinson's disease, amyotrophic lateral
sclerosis (ALS), or multiple sclerosis (MS).
• Patient has a