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
  Purpose

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


Condition
Degenerative Disc Disease

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Outcome Analysis for Minimally Invasive Spine Surgery

Further study details as provided by Weill Medical College of Cornell University:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 200
Study Start Date: May 2012
Estimated Study Completion Date: April 2013
Estimated Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
Spinal fusion patients with MIS surgery
Spinal fusion patients for whom Silicate-Substituted Calcium Phosphate Ceramic has been used as the Bone Graft

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

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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 (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.

Criteria

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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01751841

Locations
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    roger@hartlmd.net   
Principal Investigator: Roger Härtl, MD         
Sponsors and Collaborators
Weill Medical College of Cornell University
Investigators
Principal Investigator: Roger Härtl, MD Weill Cornell Neurological Surgery Department
  More Information

Additional Information:
Publications:
Responsible Party: Weill Medical College of Cornell University
ClinicalTrials.gov Identifier: NCT01751841     History of Changes
Other Study ID Numbers: 0806009851
Study First Received: November 7, 2012
Last Updated: December 13, 2012
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Intervertebral Disc Degeneration
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on August 28, 2014