Outcome Analysis for Minimally Invasive Spine Surgery and Navigation

Degenerative Disc Disease Clinical Trial

Official title:

Outcome Analysis for Minimally Invasive Spine Surgery and Navigation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01751841
• Other study ID #: 19-12021199
• Status: Completed
• Start date: May 1, 2012
• Est. completion date: October 31, 2023

Study information

• Verified date: March 2024
• Source: Weill Medical College of Cornell University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: October 31, 2023
• Est. primary completion date: October 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Degenerative Disc Disease
• Intervertebral Disc Degeneration

Locations

Country	Name	City	State
United States	Weill Cornell Brain and Spine Center	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Weill Medical College of Cornell University

Country where clinical trial is conducted

United States, 

References & Publications (1)

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/B — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual analog scale (VAS)	Pre-operative pain scores will be compared to the latest follow-up pain scores.	Up to 2 years
Secondary	Fusion on CT imaging or flexion-extension radiographs.	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.	Up to 2 years
Secondary	Oswestry Disability Index (ODI)	Pre-operative scores will be compared to the latest follow-up scores.	Up to 2 years
Secondary	Neck Disability Index (NDI)	Pre-operative scores will be compared to the latest follow-up scores.	Up to 2 years

External Links

•   Silicate-substituted calcium phosphate ceramic bone graft replacement for spinal fusion procedures.