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
  Purpose

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?


Condition
Spine Tumor

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Retrospective
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

Resource links provided by NLM:


Further study details as provided by AOSpine International:

Primary Outcome Measures:
  • overall survival [ Time Frame: Average of 10 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • local recurrence [ Time Frame: Average of 10 years ] [ Designated as safety issue: No ]

Enrollment: 1600
Study Start Date: February 2012
Study Completion Date: May 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
Surgical treatment

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Retrospective chart review and selection

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01643174

Locations
Canada
Charles Fisher
Vancouver, Canada
Sponsors and Collaborators
AOSpine International
  More Information

No publications provided

Responsible Party: AOSpine International
ClinicalTrials.gov Identifier: NCT01643174     History of Changes
Other Study ID Numbers: PT retro
Study First Received: April 17, 2012
Last Updated: June 19, 2013
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on August 26, 2014