Neurologic Complications in Spinal Deformity Surgery
Completed
Conditions studied: Adult Spinal Deformity
In brief
240 subjects with "high risk" adult spinal deformity requiring surgical correction will be enrolled in a prospective multi-center international study. "High risk" patients are defined by either their diagnoses and/or the type of surgical intervention as listed in the inclusion criteria. Neurologic complications in the form of new motor and sensory deficits will be monitored prospectively in all patients at hospital discharge, and at 6 weeks (± 2 weeks) six months (± 2 months) and 24 months(± 2 months) after the surgery. All new deficits will be adjudicated for relationship to the surgical intervention. Regression analyses will be used to evaluate the association between patient demographics, co morbidities, treatment history, spinal deformity characteristics, surgical characteristics, non-neurologic complications and pre-surgical status to occurrence of a neurologic deficit after surgery.
Key facts
- Study ID
- NCT01305343
- Run by
- AO Foundation, AO Spine
- People needed
- 273
- Starts
- 2011-08-01
- Expected to finish
- 2015-03-01
- Last updated by the study team
- 2015-12-24
Who can join
Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Signed informed consent
- Age 18 to 80 years old inclusive
- Diagnosis of adult spinal deformity with an apex of the major deformity in the cervico-thoracic or thoraco-lumbar region (Apex between C7 and L2 inclusive) with any of the following deformity characteristics
- Primary Scoliosis, Kyphosis or Kyphoscoliosis with major Cobb ≥ 80° in the coronal or sagittal plane
- Congenital Spinal Deformity undergoing corrective spinal osteotomy
- Revision Spinal Deformity undergoing corrective spinal osteotomy
- Any patient undergoing a 3-column spinal osteotomy (i.e. Pedicle Subtraction Osteotomy, Vertebral Column Resection) from C7 to L5 inclusive
- Any patient with preoperative myelopathy due to their spinal deformity
- Any patient with ossification of the Ligamentum Flavum or Posterior Longitudinal Ligament and a deformity that needs concomitant reconstruction along with decompression of the spinal cord
You may not qualify if…
- Unlikely to comply with follow-up
- Recent history ≤ 3 months of substance dependency or psychosocial disturbance
- Presence of active malignancy
- Has active, overt bacterial infection, systemic or local
- Recent (≤3 months) history of significant spinal trauma/injury/ fracture/malignancy in the spinal region
- Patients with complete, long term paraplegia
- Pregnant or nursing women, unable to agree not to become pregnant for a period of 6 months after surgery
- Prisoners
- Institutionalized individuals
Where it is running
- University of California — San Francisco, California, United States
- Norton Leatherman Spine Center — Louisville, Kentucky, United States
- Johns Hopkins University — Baltimore, Maryland, United States
- Mayo Clinic — Rochester, Minnesota, United States
- Department of Orthopaedic Surgery, Washington University School of Medicine — St Louis, Missouri, United States
- Hospital for Special Surgery — New York, New York, United States
- NYU School of Medicine — Yew York, New York, United States
- University of Virginia — Charlottesville, Virginia, United States
- University of Toronto — Toronto, Canada
- University of Hong Kong — Hong Kong, China
- Nanjing Drum Tower Hospital — Nanjing, China
- Rigshospitalet — Copenhagen, Denmark
- University School of Medicine — Hamamatsu, Japan
- Hospital Universitari Vall D'Hebron — Barcelona, Spain
- University Hospital Nottingham, NHS Trust — Nottingham, United Kingdom
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.