Table 3 Inclusion and exclusion criteria
Initial inclusion criteria | A disc herniation with back and/or leg pain (radicular pain) |
Indication for sequestrectomy according to the guidelines of German Society of Neurosurgery and the German Society of Orthopedics and Orthopedic Surgery | |
Age between 18 and 60 years | |
Physically and mentally able to participate in the study and able to understand the study, its goals, and the possible risk factors involved | |
Willing and able to participate in the follow-up visit plan at the study site and able to understand and to complete a study-relevant questionnaire in German language | |
Sufficiently informed about this trial orally and in writing. She/he had enough time for consideration, is willing to participate in the study, and gives her/his written informed consent | |
No participation in a clinical study 90 days prior to study inclusion. She/he agrees to refrain from participating in another clinical study during the NOVOCART™ Disc Study and for another 90 days after study termination | |
Initial exclusion criteria | Previous surgery at the lumbar level(s) and has been treated with NOVOCART™ Disc plus or NOVOCART™ Disc basic |
Recurrent disc herniation treated with nucleotomy/sequestrectomy of the relevant disc | |
Degenerative muscular or neurological conditions that would interfere with evaluation of outcome measures, including but not limited to Parkinson’s disease, amyotropic lateral sclerosis, multiple sclerosis, muscular dystrophy, and myelopathic diseases of different causes | |
Body Mass Index?>?35 kg/m2 | |
Current or recent history of illicit drug, nicotine (more than 20 cigarettes per day) or alcohol abuse or dependence | |
CRP?>?10 mg/dl | |
Pregnant, breastfeeding or planning to become pregnant. Female patients must be either at least 2 years postmenopausal or using one of the following means of birth control during the treatment phase, that is, for transplantation | |
• surgical sterility | |
• double barrier methods, for example, condom or diaphragm in combination with spermicide | |
• intrauterine contraceptive device | |
• bilateral vasectomy of sexual partner at least 90 days prior to enrollment in combination with barrier methods (for example, condom or diaphragm) | |
• birth control pill | |
History of known allergies or a suspicion of allergies to any of the NOVOCART™ Disc plus or basic product components, including hyaluronan, polyethylene glycol or albumin | |
Immune defects or the affinity for infections of known or unknown causes | |
Active systematic or local microbial infection, eczematization, or inflammable skin alterations at the site of surgery | |
Unable to undergo magnetic resonance imaging | |
History or suspicion of a disease with chronically inflammable character, as rheumatoid arthritis, gout, pseudo-gout, metabolic bone diseases, Crohn’s disease, ulcerative colitis, lupus erythematosus, or other autoimmune disorders | |
Known osteoporosis | |
Primary hyperparathyroidism or hyperthyroidism, chronic renal failure, or previous fragility fractures | |
Systematic connective tissue or collagen disease | |
Hereditary ocular degeneration with unclear diagnosis, retinopathies based on connective tissue-defined causes, macular corneal dystrophy | |
Immune suppression | |
History of blood coagulation disease of different genesis, including known hemorrhagic diathesis of unknown cause | |
Chemo or radiotherapy within the past 5 years or had any cancer other than nonmelanoma skin cancer treated with curative intent within the past 5 years | |
Known diabetes, drug treated | |
Ulterior concomitant diseases or functional impairments of specific organs, which exclude study participation by the assessment of the investigator | |
Radiological inclusion criteria | Single level lumbar disc herniation |
More than 50 % remaining disc height in the herniated disc in comparison to unaffected discs in the lumbar spine. If all discs show degenerative signs, disc height must be at least 5 mm | |
No obvious signs of osteophytes and no endplate sclerosis in the lumbar segment to be treated with NOVOCART™ Disc plus or NOVOCART™ Disc basic | |
Patients without adjacent degenerative discs (HD): adjacent proximal disc has no degenerative signs according to Pfirrmann Score stage 3 to 5 | |
Patients with adjacent degenerative discs (AAD): additional degenerative signs in the proximal adjacent lumbar level according to Pfirrmann 3 to 4 but no more than 25 % disc height reduction | |
Radiological exclusion criteria | Degenerative changes in the lumbar spine as determined by Modic Changes 2 to 3 |
One or more dysplastic vertebral bodies within the lumbar spine | |
Sacralized lumbar vertebra LWK 5 at the level to be treated with NOVOCART™ Disc plus or NOVOCART™ Disc basic | |
Previous or acute spondylodiscitis | |
Segmental instability (spondylolisthesis?>?5 mm) or translation?>?3 mm | |
Isthmic spondylolisthesis, ankylosing spondylitis, or spondylolysis | |
Lumbar scoliosis (>11° deformation) | |
Previous trauma, discography or any other surgical intervention at the lumbar spine | |
Previous compression or burst fracture at the level(s) to be treated with NOVOCART™ Disc plus or NOVOCART™ Disc basic | |
Central spinal canal stenosis with evidence of a narrowing of?<?8 mm (by sagittal MRI) | |
Spinal tumor | |
Metabolic bone disease | |
Facet ankylosis or severe facet degeneration | |
Lumbar kyphosis | |
Intra-surgery exclusion criteria | Extensive damage of annulus, which subsequently poses a significantly greater risk of recurrence |
Exclusion criteria after sequestrectomy | HIV, Treponema pallidum, active hepatitis B or C infection |
Exclusion criteria prior transplantation | Recurrent disc herniation after surgery and prior transplantation |