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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AOSpine International
ClinicalTrials.gov Identifier:
NCT01643174
First received: April 17, 2012
Last updated: June 19, 2013
Last verified: June 2013

April 17, 2012
June 19, 2013
February 2012
January 2013   (final data collection date for primary outcome measure)
overall survival [ Time Frame: Average of 10 years ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01643174 on ClinicalTrials.gov Archive Site
local recurrence [ Time Frame: Average of 10 years ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Predictors of Mortality and Morbidity in the Surgical Management of Primary Tumors of the Spine
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?

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.

Observational
Observational Model: Case-Only
Time Perspective: Retrospective
Not Provided
Not Provided
Probability Sample

Retrospective chart review and selection

Spine Tumor
Not Provided
Surgical treatment
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1600
May 2013
January 2013   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT01643174
PT retro
No
AOSpine International
AOSpine International
Not Provided
Not Provided
AOSpine International
June 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP