Outcome Analysis for Minimally Invasive Spine Surgery
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|ClinicalTrials.gov Identifier: NCT01751841|
Recruitment Status : Recruiting
First Posted : December 18, 2012
Last Update Posted : January 30, 2018
|Condition or disease|
|Degenerative Disc Disease|
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.
|Study Type :||Observational|
|Estimated Enrollment :||200 participants|
|Official Title:||Outcome Analysis for Minimally Invasive Spine Surgery|
|Study Start Date :||May 2012|
|Estimated Primary Completion Date :||September 2020|
|Estimated Study Completion Date :||December 2020|
Spinal fusion patients with MIS surgery
Spinal fusion patients for whom Silicate-Substituted Calcium Phosphate Ceramic has been used as the Bone Graft
- Visual analog scale (VAS) [ Time Frame: Up to 2 years ]Pre-operative pain scores will be compared to the latest follow-up pain scores.
- Fusion on CT imaging or flexion-extension radiographs. [ Time Frame: Up to 2 years ]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.
- Oswestry Disability Index (ODI) [ Time Frame: Up to 2 years ]Pre-operative scores will be compared to the latest follow-up scores.
- Neck Disability Index (NDI) [ Time Frame: Up to 2 years ]Pre-operative scores will be compared to the latest follow-up scores.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01751841
|Contact: Alyson Hignightfirstname.lastname@example.org|
|United States, New York|
|Weill Cornell Brain and Spine Center||Recruiting|
|New York, New York, United States, 10065|
|Contact: Roger Härtl, MD 212-746-5543 email@example.com|
|Principal Investigator: Roger Härtl, MD|
|Principal Investigator:||Roger Härtl, MD||Weill Cornell Neurological Surgery Department|