Overview

GENESIS is a single-centre, observational, non-interventional, no-profit, investigator-initiated study conducted at Ospedale di Vimercate, ASST Brianza (Italy).

The study describes the clinical and functional course of adult patients with cervical disc herniation and chronic discogenic neck pain who receive intradiscal radiopaque gelified ethanol (Absolute Gel), a CE-marked Class III medical device, as part of routine clinical practice and within its approved indications.

The study does not assign, introduce or modify any treatment, procedure, medication or follow-up schedule. The decision to treat is taken exclusively by the treating physician according to standard clinical practice. The study only collects clinical and radiological data generated during routine care, both retrospectively (patients already treated) and prospectively (patients treated independently of study participation).

Approximately 45 participants are planned. The main descriptive measure is the proportion of participants achieving a reduction of at least 30% in neck pain intensity (Visual Analogue Scale, VAS) at 1 month compared with baseline. Participants are followed up to 48 months after treatment.

All analyses are descriptive. The study is not designed to demonstrate efficacy, to support causal inference, or to perform comparisons with other treatments.

Eligibility

Inclusion Criteria:

• Male or female, aged 18 to 75 years, already treated with or candidate for Absolute Gel for cervical disc herniation as part of standard clinical practice
• Signed informed consent to participate in the study (prospective participants; retrospective participants according to the conditions approved by the Ethics Committee)
• Discogenic neck pain confirmed by a history of cervical neck pain, with at least 3 months of continuous pain or 6 months of acute recurrent episodes despite conservative treatment including analgesics and physiotherapy
• Baseline neck pain intensity VAS greater than 4 out of 10
• Cervical disc herniation documented by MRI
• Contained herniation without complete annulus tear, with integrity of the posterior longitudinal ligament and no free fragments, assessed by MRI or CT

Exclusion Criteria:

• Active local or systemic infection (systemic or cervical)
• Known contraindications to ethanol or to device components
• Coagulopathy or anticoagulant therapy that cannot be discontinued according to clinical practice
• Serious medical or systemic disease making the treatment inappropriate according to clinical judgement
• Psychiatric or cognitive disorders preventing a reliable assessment
• Pregnancy or breastfeeding
• Sequestered or migrated disc herniation
• Severe disc degeneration not compatible with the clinical use of Absolute Gel (for example disc collapse greater than 60%, Pfirrmann grade IV-V according to clinical judgement)
• Clinically significant severe foraminal or central stenosis
• Instability (for example spondylolisthesis greater than Meyerding grade I)
• Significant vertebral abnormalities (for example fractures, active angiomas, severe scoliosis greater than 20 degrees Cobb, significant kyphosis)
• Severe posterior osteophytes compromising access or treatment safety
• Clinically significant facet joint disorders (for example severe osteoarthritis)
• Inadequate skin coverage or local conditions impeding the procedure
• Previous cervical surgery at the treated disc level
• Severe neurological deficit (for example motor strength less than 3/5) not exclusively attributable to the contained herniation
• Any other condition that, in the judgement of the treating physician, makes the treatment inappropriate in routine clinical practice