Clinical trial NCT01643174: Predictors of Mortality and Morbidity in the Surgical Management of Primary Tumors of the Spine
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Spine Tumor
Lead sponsor: AO Foundation, AO Spine
Sponsor class: OTHER
First posted: 2012-07-18
Enrollment: 1600
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Retrospective chart review and selection

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.

Eligibility criteria: 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

Primary outcomes:
measure: overall survival
timeFrame: Average of 10 years
Secondary outcomes:
measure: local recurrence
timeFrame: Average of 10 years
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: Charles Fisher
Study officials:
References:
citation: 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.