Outcome Analysis for Minimally Invasive Spine Surgery and Navigation

NCT01751841 | Completed

• 1 other identifier: 19-12021199
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Degenerative Disc Disease

Outcome Measures

Primary Outcomes (1)

• Visual analog scale (VAS)

  Pre-operative pain scores will be compared to the latest follow-up pain scores.

  Up to 2 years

Secondary Outcomes (3)

• Fusion on CT imaging or flexion-extension radiographs.

  Up to 2 years

• Oswestry Disability Index (ODI)

  Up to 2 years

• Neck Disability Index (NDI)

  Up to 2 years

Study Arms (1)

Spinal fusion patients with minimally invasive spine surgery

Spinal fusion patients for whom Silicate-Substituted Calcium Phosphate Ceramic has been used as the Bone Graft

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• \- 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.

You may not qualify if:

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

Sponsors & Collaborators

• Weill Medical College of Cornell University: lead

Study Sites (1)

Weill Cornell Brain and Spine Center

New York, New York, 10065, United States

Location

Related 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/BRS.0b013e318265e22e.

  PMID: 22744618 RESULT

Related Links

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

MeSH Terms

Conditions

Intervertebral Disc Degeneration

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Study Officials

• Roger Härtl, MD

  Weill Cornell Neurological Surgery Department

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 7, 2012
• First Posted: December 18, 2012
• Study Start: May 1, 2012
• Primary Completion: October 31, 2023
• Study Completion: October 31, 2023
• Last Updated: March 29, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)