Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Outcome Analysis for Minimally Invasive Spine Surgery

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2012 by Weill Medical College of Cornell University
Sponsor:
Information provided by (Responsible Party):
Weill Medical College of Cornell University
ClinicalTrials.gov Identifier:
NCT01751841
First received: November 7, 2012
Last updated: December 13, 2012
Last verified: December 2012

November 7, 2012
December 13, 2012
May 2012
April 2013   (final data collection date for primary outcome measure)
Visual analog scale (VAS) [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]
Pre-operative pain scores will be compared to the latest follow-up pain scores.
Same as current
Complete list of historical versions of study NCT01751841 on ClinicalTrials.gov Archive Site
  • Fusion on CT imaging or flexion-extension radiographs. [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Pre-operative scores will be compared to the latest follow-up scores.
  • Neck Disability Index (NDI) [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]
    Pre-operative scores will be compared to the latest follow-up scores.
Same as current
Not Provided
Not Provided
 
Outcome Analysis for Minimally Invasive Spine Surgery
Outcome Analysis for Minimally Invasive Spine Surgery

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

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.

Observational
Observational Model: Case-Only
Time Perspective: Retrospective
Not Provided
Not Provided
Probability Sample

Our prospectively collected institutional database will be reviewed to identify all consecutive patients with spinal fusion procedures using Silicate-Substituted Calcium Phosphate (Actifuse®, Baxter, Deerfield, IL) 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.

Degenerative Disc Disease
Not Provided
Spinal fusion patients with MIS surgery
Spinal fusion patients for whom Silicate-Substituted Calcium Phosphate Ceramic has been used as the Bone Graft
Nagineni VV, James AR, Alimi M, Hofstetter C, Shin BJ, Njoku I Jr, Tsiouris AJ, Härtl R. Silicate-substituted calcium phosphate ceramic bone graft replacement for spinal fusion procedures. Spine (Phila Pa 1976). 2012 Sep 15;37(20):E1264-72.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
200
April 2013
April 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

- Patients with different spinal fusion procedures (including AxiaLIF (axial lumbar interbody fusion), TLIF (transforaminal lumbar interbody fusion), ELIF (extreme lateral interbody fusion), PCF (posterior cervical fusion), and ACDF (anterior discectomy and fusion)) using Silicate-Substituted Calcium Phosphate (Actifuse®, Baxter, Deerfield, IL) as a bone graft substitute.

Exclusion Criteria:

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

Both
Not Provided
No
United States
 
NCT01751841
0806009851
No
Weill Medical College of Cornell University
Weill Medical College of Cornell University
Not Provided
Principal Investigator: Roger Härtl, MD Weill Cornell Neurological Surgery Department
Weill Medical College of Cornell University
December 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP