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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:
Participants will be implanted with DISC Care and followed up for two years (7 visits).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DISC Care | Experimental | DISC Care implant |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DISC Care | Device | Medical device to prevent disc herniation recurrence |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of clinically symptomatic recurrent lumbar disc herniation | 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence and type of all adverse events (AE) and serious adverse events (SAE). | 6 weeks, 6 months, 12 months, and 24 months | |
| Incidence of clinically asymptomatic recurrent disc herniation | 6 months, 12 months, and 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Description of the impact of the procedure (implantation of the device) on the perioperative parameters | Blood loss (mL) | Surgery |
| Description of the impact of the procedure (implantation of the device) on the perioperative parameters |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Laia Rofes, PhD | Contact | +34 935944726 | lrofes@neosurgery.com | |
| Daniel Alvarez, PhD | Contact | +34 935944726 | dalvarez@neosurgery.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitari de Bellvitge | Recruiting | L'Hospitalet de Llobregat | Barcelona | 08907 | Spain |
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| ID | Term |
|---|---|
| D007405 | Intervertebral Disc Displacement |
| ID | Term |
|---|---|
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D006547 | Hernia |
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| Incidence of re-interventions | 6 weeks, 6 months, 12 months, and 24 months |
| Disc height maintenance [mm] related to baseline | 6 months, 12 months, and 24 months |
| Change in leg and low back pain, related to baseline | 0-10 NRS (numeric rating scale) | 6 weeks, 6 months, 12 months, and 24 months |
| Change in Low back related disability, related to baseline | Oswestry Disability Index (ODI) | 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) | 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 | 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) | 6 months, 12 months, and 24 months |
| the direct and indirect costs of the disease and the intervention. | Custom-made questionnaire | 6 weeks, 6 months, 12 months, and 24 months |
X-ray exposition (seconds of x-ray exposition)
| Surgery |
| Description of the impact of the procedure (implantation of the device) on the perioperative parameters | Surgery duration (minutes) | Surgery |
| Hospital La Princesa | Not yet recruiting | Madrid | Madrid | 28006 | Spain |
|
| Hospital General Universitario Gregorio Marañón | Recruiting | Madrid | Madrid | 28007 | Spain |
|
| Hospital Universitario Fundación Jiménez Díaz | Recruiting | Madrid | Madrid | 28040 | Spain |
|
| Hospital Universitario la Paz | Recruiting | Madrid | Madrid | 28046 | Spain |
|
| Hospital QuirónSalud Barcelona | Recruiting | Barcelona | Spain |
|
| Hospital Universitario de Canarias | Not yet recruiting | San Cristóbal de La Laguna | Spain |
|
| D020763 |
| Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |