The goal of this clinical investigation is to learn about DISC Care, an Hernia Blocking System, in patients who have undergone lumbar disc hernia surgery. The main questions it aims to answer are: * if the implant (DISC Care) prevents disc herniation recurrence * if DISC Care is a safe device Participants will be implanted with DISC Care and followed up for two years (7 visits).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
PREVENTION
Masking
NONE
Enrollment
30
Medical device to prevent disc herniation recurrence
Hospital Universitari de Bellvitge
L'Hospitalet de Llobregat, Barcelona, Spain
RECRUITINGHospital La Princesa
Madrid, Madrid, Spain
NOT_YET_RECRUITINGHospital General Universitario Gregorio Marañón
Madrid, Madrid, Spain
Incidence of clinically symptomatic recurrent lumbar disc herniation
Time frame: 24 months
Incidence and type of all adverse events (AE) and serious adverse events (SAE).
Time frame: 6 weeks, 6 months, 12 months, and 24 months
Incidence of clinically asymptomatic recurrent disc herniation
Time frame: 6 months, 12 months, and 24 months
Incidence of re-interventions
Time frame: 6 weeks, 6 months, 12 months, and 24 months
Disc height maintenance [mm] related to baseline
Time frame: 6 months, 12 months, and 24 months
Change in leg and low back pain, related to baseline
0-10 NRS (numeric rating scale)
Time frame: 6 weeks, 6 months, 12 months, and 24 months
Change in Low back related disability, related to baseline
Oswestry Disability Index (ODI)
Time frame: 6 weeks, 6 months, 12 months, and 24 months
The change in quality of life, compared to baseline
EQ-5D-5L (5-level EQ-5D version)
Time frame: 6 weeks, 6 months, 12 months, and 24 months
The change in patient neurological status, compared to baseline
straight leg raise test, reflexes, motor muscle strength and sensory neurological evaluations, classified as normal or abnormal
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Hospital Universitario Fundación Jiménez Díaz
Madrid, Madrid, Spain
RECRUITINGHospital Universitario la Paz
Madrid, Madrid, Spain
RECRUITINGHospital QuirónSalud Barcelona
Barcelona, Spain
RECRUITINGHospital Universitario de Canarias
San Cristóbal de La Laguna, Spain
NOT_YET_RECRUITINGTime frame: 6 weeks, 6 months, 12 months, and 24 months
The degeneration of the disc, in comparison with the preoperative state
Pfirrmann intervertebral disc degeneration scale (I, II, III, IV, V)
Time frame: 6 months, 12 months, and 24 months
the direct and indirect costs of the disease and the intervention.
Custom-made questionnaire
Time frame: 6 weeks, 6 months, 12 months, and 24 months