Various spinal pathologies requiring surgical stabilization
Conditions
Interventions
Spinal instrumentation using pedicle screws
Sponsors
SentryX
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: - Males and females aged 18 years and older - Planned for open or percutaneous* posterior instrumentation with a minimum of 4 new pedicle screws with a diameter of 5 to 7,5 mm (inclusive). - Concomitant posterolateral fusion, vertebral augmentation, intervertebral body fusion devices, osteotomies and posterior decompression are acceptable - Willing and able to comply with the protocol for the duration of the study - Give written informed consent prior to any study-related procedure not part of the standard practice, with the understanding that the consent may be withdrawn by the patient at any time without prejudice to his/her (post-)surgery care
Exclusion criteria
Exclusion criteria: - Concomitant anterior/lateral procedures (e.g. vertebral cage, anterior plating, ALIF/XLIF) - ASA-classification > 3 - Disrupted pain perception according to the treating physician - High risk of intra-/postoperative complications (e.g. multiple prior procedures) - Indication for surgery being: Active or previous (para)spinal infection; Malignancy; Fracture/other traumatic injury; Indication for an epidural catheter; Indication for local infiltration analgesics with amino-amide anesthetics; Known intolerance to patch adhesives; Participation in an interventional study interfering with standard care
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pain, opioid usage and mobilization | — |
Secondary
| Measure | Time frame |
|---|---|
| Medicine use, side-effects, adverse events, length of stay in the hospital, discharge destination, and patient satisfaction | — |
Contacts
Public ContactSuzanne Bruins
SentryX
Outcome results
None listed