Gelified Radiopaque Ethanol (Absolute Gel) for Cervical Disc Herniation: an Observational Study in Routine Clinical Practice - GENESIS Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Proportion of participants with a reduction of at least 30% in neck pain intensity (VAS) at 1 month
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Absolute Gel in routine clinical practice
Adults with cervical disc herniation and chronic discogenic neck pain who receive, or have already received, intradiscal radiopaque gelified ethanol (Absolute Gel) as part of routine clinical practice, based exclusively on the decision of the treating physician. The single cohort includes both retrospectively and prospectively enrolled participants. No treatment is assigned by the study.
干预措施: Absolute Gel (radiopaque gelified ethanol) (Device)
结局指标
主要结局
Proportion of participants with a reduction of at least 30% in neck pain intensity (VAS) at 1 month
时间窗: Baseline and 1 month (+/-14 days) after treatment
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.
Change from baseline in neck pain intensity (VAS) at 1 month
时间窗: Baseline and 1 month (+/-14 days) after treatment
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.
次要结局
- Change from baseline in neck pain intensity (VAS) over time(Baseline, 3, 12, 24, 36 and 48 months)
- Proportion of participants with a reduction of at least 50% in neck pain intensity (VAS)(Baseline, 1, 3, 12, 24, 36 and 48 months)
- Patient Global Impression of Change (PGIC)(1, 3, 12, 24, 36 and 48 months)
- Change from baseline in cervical function measured with the Copenhagen Neck Functional Disability Scale (CNFDS)(Baseline, 1, 3, 12, 24, 36 and 48 months)
- Change from baseline in cervical function measured with the Neck Pain and Disability Scale (NPAD)(Baseline, 1, 3, 12, 24, 36 and 48 months)
- Use of analgesic and anti-inflammatory medication compared with baseline(Baseline, 1, 3, 12, 24, 36 and 48 months)
- Number of participants with adverse events, serious adverse events and serious adverse device effects(From the procedure up to 48 months)
- Number of participants with adverse events of special interest (AESI)(From the procedure up to 48 months)
- Number of participants undergoing surgical re-intervention at the treated level(30, 90 and 365 days after the procedure)
- Number of device deficiencies or device malfunctions reported(From the procedure up to 48 months)
- Radiological findings on cervical MRI performed as part of routine care(Baseline (MRI not older than 6 months) and approximately 3 months, when performed for clinical reasons)
研究者
Aurel Mengri
Principal Investigator and Sponsor-Investigator
ASST Brianza - Ospedale di Vimercate