Gelified Radiopaque Ethanol (Absolute Gel) in Cervical Disc Herniation: an Observational Study in Routine Clinical Practice (GENESIS)

Aurel Mengri45 enrolled

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.

Cervical disc herniation with chronic discogenic neck pain is commonly managed with conservative treatment, which may show limited long-term effectiveness, or with surgery, which carries higher risks and longer recovery times. Intradiscal chemonucleolysis with radiopaque gelified ethanol is a minimally invasive option already used in routine clinical practice with a CE-marked device (Absolute Gel, Class III). Published clinical evidence remains limited, particularly with long-term follow-up.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Cervical Disc Herniation Intervertebral Disc Displacement

Interventions

Absolute Gel (radiopaque gelified ethanol)DEVICE

CE-marked Class III medical device used within its approved indications as part of standard clinical care. Intradiscal injection of radiopaque gelified ethanol at the cervical level, performed under fluoroscopic guidance through an antero-lateral approach with local anaesthesia, typically 0.3 to 0.4 mL per disc. The study does not assign, impose or modify the treatment, the technique or the peri-procedural management; it records the procedure as performed in routine practice.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Proportion of participants with a reduction of at least 30% in neck pain intensity (VAS) at 1 month

Neck pain intensity is measured with the Visual Analogue Scale (VAS), a 0 to 10 scale where 0 = no pain and 10 = worst imaginable pain. Lower scores indicate less pain. The measure is the proportion of participants whose VAS score at 1 month is reduced by at least 30% compared with baseline, reported with exact 95% binomial confidence intervals. Descriptive only; no hypothesis testing is performed.

Time frame: Baseline and 1 month (+/-14 days) after treatment

Change from baseline in neck pain intensity (VAS) at 1 month

Continuous change from baseline in VAS score (0 to 10; lower scores indicate less pain), summarised with mean, standard deviation, median, interquartile range and range. Descriptive only.

Time frame: Baseline and 1 month (+/-14 days) after treatment

Secondary Outcomes

Change from baseline in neck pain intensity (VAS) over time

VAS scores (0 to 10; lower scores indicate less pain) and changes from baseline at each scheduled follow-up, summarised descriptively.

Time frame: Baseline, 3, 12, 24, 36 and 48 months

Proportion of participants with a reduction of at least 50% in neck pain intensity (VAS)

Proportion of participants achieving a reduction of at least 50% in VAS score compared with baseline, reported descriptively as an indicator of a more pronounced clinical response.

Time frame: Baseline, 1, 3, 12, 24, 36 and 48 months

Patient Global Impression of Change (PGIC)

Self-reported perception of overall change assessed with the PGIC scale (7 categories, from "very much improved" to "very much worse"; lower scores indicate greater perceived improvement). Reported as frequency distributions; the proportion of participants reporting "much improved" or "very much improved" may be reported with 95% confidence intervals, for descriptive purposes only.

Time frame: 1, 3, 12, 24, 36 and 48 months

Change from baseline in cervical function measured with the Copenhagen Neck Functional Disability Scale (CNFDS)

CNFDS is a validated 15-item questionnaire assessing neck-related functional disability, with a total score from 0 to 30; higher scores indicate greater disability. Changes from baseline are summarised descriptively.

Time frame: Baseline, 1, 3, 12, 24, 36 and 48 months

Change from baseline in cervical function measured with the Neck Pain and Disability Scale (NPAD)

NPAD is a validated 20-item questionnaire assessing neck pain and related disability, with a total score from 0 to 100; higher scores indicate greater pain and disability. Changes from baseline are summarised descriptively.

Time frame: Baseline, 1, 3, 12, 24, 36 and 48 months

Use of analgesic and anti-inflammatory medication compared with baseline

Qualitative and quantitative documentation of analgesic, NSAID and corticosteroid use (type, dose, duration, indication) recorded during routine follow-up and compared with pre-treatment use. Descriptive only.

Time frame: Baseline, 1, 3, 12, 24, 36 and 48 months

Number of participants with adverse events, serious adverse events and serious adverse device effects

Incidence, type, severity, outcome and relatedness (device, procedure, other) of adverse events (AE), serious adverse events (SAE) and serious adverse device effects (SADE), collected within predefined windows: 0-24 hours, day 1-30, day 31-90, day 91-365 and beyond 365 days up to 48 months.

Time frame: From the procedure up to 48 months

Number of participants with adverse events of special interest (AESI)

Predefined AESIs: discitis/osteomyelitis; procedure-related meningitis; worsening radiculopathy with new or progressive neurological deficit.

Time frame: From the procedure up to 48 months

Number of participants undergoing surgical re-intervention at the treated level

Surgical re-intervention at the treated disc level, recorded as a clinically relevant marker of treatment failure or complication.

Time frame: 30, 90 and 365 days after the procedure

Number of device deficiencies or device malfunctions reported

Device deficiencies and malfunctions documented and reported in accordance with ISO 14155 and Regulation (EU) 2017/745.

Time frame: From the procedure up to 48 months

Radiological findings on cervical MRI performed as part of routine care

Descriptive reporting of morphological disc findings (treated level, herniation morphology, Pfirrmann grade, nerve root compression, other structural findings). No imaging is mandated by the study; MRI data are collected only if performed as part of routine clinical care.

Time frame: Baseline (MRI not older than 6 months) and approximately 3 months, when performed for clinical reasons

Gelified Radiopaque Ethanol (Absolute Gel) in Cervical Disc Herniation: an Observational Study in Routine Clinical Practice (GENESIS)

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts