Predictors of Mortality and Morbidity in the Surgical Management of Primary Tumors of the Spine (PT)

Predictors of Mortality and Morbidity in the Surgical Management of Primary Tumors of the Spine: A Multi-center Retrospective Cohort Study With a Cross-Sectional Survival Check

Within defined groups of primary malignant and benign bone and soft tissue spine tumors, what variables (clinical, diagnostic, therapeutic, and/or demographic) are associated with overall survival?

Study Overview

• Status: Completed
• Conditions: Spine Tumor

Detailed Description

Primary tumors of the spine are exceedingly rare and therefore the literature has been limited to case series of limited size and significant heterogeneity. These tumors comprise 11% of all Primary Musculoskeletal Tumors and 4.2% of all spine tumors. Of all primary spine tumors only 6% are malignant, but it is the malignant tumors that present the greatest therapeutic challenges. Through this multi-center retrospective cohort study performed at 13 spine oncology referral, data on at least 2.000 patients with specific primary benign and malignant spine tumors will be collected. This will provide power to determine the influence of many previously hypothesized variables on outcome.

The purpose of this study is to determine clinical, imaging and treatment factors that influence patient survival, local recurrence rate, and peri-operative/post-operative morbidity. Most surgical options carry significant morbidity and consume vast resources. In contrast, there is emerging evidence that incomplete or oncologically inappropriate resection increases local recurrence rate and decreases overall survival. These data will be used to refine existing study questions regarding patient outcomes and to develop new study questions that will be assessed in the future using prospectively collected data.

• Study Type: Observational
• Enrollment (Actual): 1600

Contacts and Locations

Study Locations

• Canada
  • Vancouver, Canada
    • Charles Fisher

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Retrospective chart review and selection

Description

Inclusion Criteria:

• Were admitted to one of the participating spine centers with a diagnosis of primary tumor of the spine and were treated surgically.
• At least one follow-up detectable in the medical charts

Exclusion Criteria:

• metastatic tumor of the spine
• primary spinal cord tumor

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Surgical treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
overall survival	Average of 10 years

Secondary Outcome Measures

Outcome Measure	Time Frame
local recurrence	Average of 10 years

Collaborators and Investigators

• Sponsor: AO Foundation, AO Spine

Publications and helpful links

General Publications

• Fisher CG, Goldschlager T, Boriani S, Varga PP, Rhines LD, Fehlings MG, Luzzati A, Dekutoski MB, Reynolds JJ, Chou D, Berven SH, Williams RP, Quraishi NA, Bettegowda C, Gokaslan ZL. An evidence-based medicine model for rare and often neglected neoplastic conditions. J Neurosurg Spine. 2014 Nov;21(5):704-10. doi: 10.3171/2014.7.SPINE13954. Epub 2014 Sep 5.

Study record dates

Study Major Dates

• Study Start: February 1, 2012
• Primary Completion (ACTUAL): January 1, 2013
• Study Completion (ACTUAL): May 1, 2013

Study Registration Dates

• First Submitted: April 17, 2012
• First Submitted That Met QC Criteria: July 16, 2012
• First Posted (ESTIMATE): July 18, 2012

Study Record Updates

• Last Update Posted (ESTIMATE): June 20, 2013
• Last Update Submitted That Met QC Criteria: June 19, 2013
• Last Verified: June 1, 2013

More Information

Terms related to this study

• Other Study ID Numbers: PT retro