Prospective, multi-center, single-arm clinical study to assess the performance of an Hernia Blocking System in preventing clinically symptomatic recurrent lumbar disc herniation.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Hernia Blocking System device implanted during a lumbar discectomy procedure
Hospital Germans Trias i Pujol
Badalona, Spain
Hospital QuirónSalud Barcelona
Barcelona, Spain
Hospital Universitari de Bellvitge
Barcelona, Spain
Hospital General Universitario Gregorio Marañón
Madrid, Spain
Incidence of clinically symptomatic recurrent lumbar disc herniation
Time frame: 24 months
The 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
Disc height maintenance [mm] related to baseline
Time frame: 6 weeks, 6 months, 12 months, and 24 months
Change in leg and low back pain assessed by NRS (numeric rating scale), related to baseline
0-10 NRS
Time frame: 6 weeks, 6 months, 12 months, and 24 months
Change in Low back related disability according to the Oswestry Disability Index (ODI), related to baseline
Time frame: 6 weeks, 6 months, 12 months, and 24 months
The change in quality of life according to EQ-5D-5L, compared to baseline
Time frame: 6 weeks, 6 months, 12 months, and 24 months
The change in the patient work status, compared to baseline
Time frame: 6 weeks, 6 months, 12 months, and 24 months
The change in patient neurological status: straight leg raise test, reflexes, motor muscle strength and sensory neurological evaluations, compared to baseline
Time frame: 6 weeks, 6 months, 12 months, and 24 months
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Hospital Universitario Fundación Jiménez Díaz
Madrid, Spain
Hospital Universitario de Canarias
San Cristóbal de La Laguna, Spain
The change in the kinematics of the intervertebral disc at the index level, compared to baseline
Time frame: 6 weeks, 6 months, 12 months, and 24 months
The change in the disc degeneration (Pfirrmann scale), compared to baseline
Time frame: 6 months, 12 months, and 24 months
The change in the endplate lesions (MODIC scale), compared to baseline
Time frame: 6 months, 12 months, and 24 months