About this trial
Multi-center, prospective, non-randomized study to evaluate outcomes of surgically treated patients with adult cervical spinal deformity.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
≥18 years old at time of treatment
C2-C7 sagittal kyphosis (Cobb > 15 degrees)
T1S-CL > 35o
Segmental cervical kyphosis > 10 degrees between any 2 vertebra between C2-T1 or > 15 degrees across any 3 vertebra between C2-T1
Disqualifiers
Active spine tumor or infection
Deformity due to acute trauma
Unwilling to provide consent or to complete study forms
Prisoner
Trial population
Spine Surgeon Clinic
Trial design
Cohort
Prospective
Treatments tested in this trial
Surgical intervention
Procedure/SurgerySurgical interventions will be patient specified by treating surgeon.
Treatment groups
Trial outcomes
Primary outcomes
Pain Numeric rating scale (NRS) - Headaches
Self-reported pain in Head where 0=no pain/10=severe pain
Pain Numeric rating scale (NRS) - Neck
Self-reported pain in Neck where 0=no pain/10=severe pain
Pain Numeric rating scale (NRS) - Upper extremity
Self-reported pain in Arms where 0=no pain/10=severe pain
Pain Numeric rating scale (NRS) - Lower extremity
Self-reported pain in Legs where 0=no pain/10=severe pain
Secondary outcomes
EAT-10
Measures swallowing difficulties as reported by the patient.
Voice Handicap Index (VHI-10)
Measures voice handicap as reported by the patient.
Adverse evnts
Any adverse events occurring \& meeting study established reporting criteria
Edmonton Frail Scale
Frailty scale from 0 to 17 where the higher the score the more frail the patient
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
International Spine Study Group Foundation
Lead sponsor
DePuy Synthes
Collaborator
Orthofix Inc.
Collaborator