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

Spine Tumor Clinical Trial

— PT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01643174
• Other study ID #: PT retro
• Status: Completed
• Phase: N/A
• First received: April 17, 2012
• Last updated: June 19, 2013
• Start date: February 2012
• Est. completion date: May 2013

Study information

• Verified date: June 2013
• Source: AOSpine International
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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?

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1600
• Est. completion date: May 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Case-Only, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Spine Tumor

Locations

Country	Name	City	State
Canada	Charles Fisher	Vancouver

Sponsors (1)

Lead Sponsor	Collaborator
AOSpine International

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	overall survival		Average of 10 years	No
Secondary	local recurrence		Average of 10 years	No