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

Completed

• Conditions: Spine Tumor

• Registration Number: NCT01643174
• Lead Sponsor: AO Foundation, AO Spine

Brief Summary

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?

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 Timeline

• Study Start: 2012-02
• Study First Submitted: 2012-04-17
• Study First Submitted QC: 2012-07-16
• Study First Posted: 2012-07-18
• Primary Completion: 2013-01
• Study Completion: 2013-05
• Status Verified: 2013-06
• Last Update Submitted: 2013-06-19
• Last Update Posted: 2013-06-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1600

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
overall survival	Average of 10 years

Secondary Outcome Measures

Name	Time	Method
local recurrence	Average of 10 years

Trial Locations

Locations (1)

Charles Fisher; 🇨🇦 Vancouver, Canada