Intrathecal baclofen pump versus selective dorsal rhizotomy for non-ambulatory children with cerebral palsy

Condition studied

Cerebral Palsy

Investigational medicinal product(s)

Eligibility

Primary endpoint

Change in CP-CHILD caregiver version (in absolute value) in the first year postoperatively vs. immediately preoperatively (non-inferiority margin = clinically meaningful difference = 5/100).

Endpoint detail

Key secondary endpoints: Adverse events; cost-effectiveness and cost-utility. Additional secondary endpoints: Spasticity; range of motion; trunk control; communication; orobulbar function; sleep; urinary symptoms; spinal/hip deformities; medication use; quality of life; treatment goals; parental distress; patient satisfaction; healthcare costs; complications.