Zusammenfassung (Niederländisch oder Französisch oder Englisch)
Trial Description
| Title | Intrathecal baclofen pump versus selective dorsal rhizotomy for non-ambulatory children with cerebral palsy (ITB vs. SDR) |
| Participants (P) | Children aged ≥ 4 years and < 18 years with spastic cerebral palsy (CP). Who have gross motor function classification system (GFMCS) grade 4 or 5. And whose spasticity is insufficiently controlled with conservative therapy and/or oral baclofen or who have intolerable side effects. |
| Intervention (I) | Selective Dorsal Rhizotomy (SDR) is a neurosurgical intervention which is exclusively performed in large university hospitals. In brief, a L1 laminectomy and durotomy is performed and approximately one third of each dorsal root between L2 and S1 is cut bilaterally under neurophysiological monitoring, followed by a ~1 week inpatient rehabilitation period. |
| Control (C) | Intrathecal baclofen (ITB) is a neurosurgical intervention which is typically performed in large academic centres in NL and BE. In brief, in the low lumbar area, the thecal sac is punctured and a spinal catheter is inserted under fluoroscopic guidance. Next, an abdominal wall pocket is created, and a subcutaneous catheter is tunnelled between both incisions and connected to a subcutaneous pump. Postoperative schedule is similar to SDR. |
| Outcome (O) | 1. Change in CP-CHILD caregiver version (in absolute value) during the 1st year postoperatively vs. immediately preoperatively (comparing SDR to ITB, non-inferiority design, 5/100 as clinically meaningful difference and noninferiority margin). 2. AE, SAE and SUSAR frequency, severity and causality in the first year postoperatively (comparing SDR to ITB). 3. Cost-effectiveness and cost-utility during the first postoperative year (comparing SDR to ITB). |
| Trial Design | Randomized (1:1), international, multicentric, parallel group, unblinded, pragmatic controlled trial testing non-inferiority (for the primary outcome CP-CHILD) / superiority (for all other outcomes). |
| Sample Size | 48 participants |
| Trial duration | 81 months from FPI to CSR (excluding LT-FU) and 148 months including LT-FU |
| Budget | 730.000 € |
Trial team
| Sponsor | UZ Leuven |
| Chief Investigator | Prof. Dr. Philippe De Vloo |
| External partners | Annemieke Buizer, Amsterdam UMC, The Netherlands |
| Number of participating sites in Belgium | UZ Leuven, UZ Antwerpen, UZ Gent, Cliniques Universitaires Saint-Luc & UZ Brussel |
