Clinical trial NCT01751841: Outcome Analysis for Minimally Invasive Spine Surgery and Navigation
Official title: Outcome Analysis for Minimally Invasive Spine Surgery and Navigation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Degenerative Disc Disease
Lead sponsor: Weill Medical College of Cornell University
Sponsor class: OTHER
First posted: 2012-12-18
Enrollment: 200
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Our prospectively collected institutional database will be reviewed to identify all consecutive patients with spinal fusion procedures using Silicate-Substituted Calcium Phosphate as a bone graft substitute. Surgeries have been performed at our hospital between 2007 and 2011. The estimated number of patients enrolled in the study is 200 patients. Patient demographics will be extracted using the database. The study population are from different age, gender and ethnicity groups. The indications for surgery will be recorded for each patient, as well. Institutional Research Board approval has been granted. All patients have provided informed consent for data collection regarding their treatment and outcomes.

Brief summary: Prospective/Retrospective data analysis, chart reviews and clinical outcomes of minimally invasive spine surgery

Detailed description: STUDY RATIONALE AND PRIMARY OBJECTIVE/HYPOTHESIS To assess the clinical and radiographic outcome of spinal fusion procedures using Silicate-Substituted Calcium Phosphate (Si-CaP), a newer-generation of synthetic ceramics designed to maximize osteoinduction and osteoconduction.

STUDY DESIGN Retrospective Study

PURPOSE OF THE STUDY Providing compelling evidence for the efficacy of Si-CaP in terms of resulting in satisfactory fusion.

SUMMARY OF METHODS A prospectively collected database will be reviewed retrospectively, to retrieve data of 200 patients who have undergone different spinal fusion procedures using Silicate-Substituted Calcium Phosphate (Si-CaP). An average follow up duration of at least 12 months will be considered. Clinical outcomes will be assessed using the visual analog scale (VAS), Oswestry Disability Index (ODI), and Neck Disability Index (NDI). Pre-operative scores will be compared to the latest follow-up scores. A board certified Neuro-radiologist will assess the fusion rate. Fusion will be determined by the presence of bony bridging on 2 consecutive sections in at least 2 planes on computed tomographic imaging.

SECONDARY ENDPOINTS AND EXPECTED RESULTS The purpose of this study is to evaluate the level of clinical and radiographic improvement in patients implanted with Silicate-Substituted Calcium Phosphate (Si-CaP) as a bone graft substitute material for spinal fusions. More comprehensive long term studies will be able to provide compelling evidence for the efficacy of Si-CaP in terms of resulting in satisfactory fusion. They can more strongly support the previously published data implying that Si-CaP can be utilized as an alternative to autogenous bone graft in spinal arthrodesis procedures.

Eligibility criteria: Inclusion Criteria:

- Patients with different spinal fusion procedures (including axial lumbar interbody fusion, transforaminal lumbar interbody fusion, extreme lateral interbody fusion, posterior cervical fusion, and anterior discectomy and fusion using Silicate-Substituted Calcium Phosphate as a bone graft substitute.

Exclusion Criteria:

- Utilization of any other bone extenders in addition to Si-CaP as a bone graft substitute.

Primary outcomes:
measure: Visual analog scale (VAS)
timeFrame: Up to 2 years
Secondary outcomes:
measure: Fusion on CT imaging or flexion-extension radiographs.
timeFrame: Up to 2 years
measure: Oswestry Disability Index (ODI)
timeFrame: Up to 2 years
measure: Neck Disability Index (NDI)
timeFrame: Up to 2 years
Other outcomes:
Locations:
city: New York
country: United States
facility: Weill Cornell Brain and Spine Center
state: New York
Study officials:
affiliation: Weill Cornell Neurological Surgery Department
name: Roger Härtl, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Nagineni VV, James AR, Alimi M, Hofstetter C, Shin BJ, Njoku I Jr, Tsiouris AJ, Hartl R. Silicate-substituted calcium phosphate ceramic bone graft replacement for spinal fusion procedures. Spine (Phila Pa 1976). 2012 Sep 15;37(20):E1264-72. doi: 10.1097/BRS.0b013e318265e22e.