SOLAS® Spinal Surgery Registry

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
NuVasive
ClinicalTrials.gov Identifier:
NCT01372592
First received: March 25, 2011
Last updated: February 14, 2014
Last verified: February 2014

March 25, 2011
February 14, 2014
March 2011
December 2023   (final data collection date for primary outcome measure)
To create a database of radiographic and clinical outcome measures of spinal surgery patients to evaluate the efficacy of various procedures for multiple diagnoses. [ Time Frame: 24 months then annually thereafter ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01372592 on ClinicalTrials.gov Archive Site
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SOLAS® Spinal Surgery Registry
SOLAS® Spinal Surgery Registry: Prospective Clinical and Radiographic Outcomes Data Collection in Degenerative, Deformity, and Trauma Patients

The SOLAS Spinal Surgery Registry is a prospective multi-center observational data collection initiative, to capture clinical and radiographic outcomes in candidates for spine surgery with degenerative, deformity, and traumatic pathologies. As an observational database, there are no initial driving hypotheses, but rather data will be mined to answer unforeseen questions, but which may include broad topics such as comparative effectiveness between and among various surgical treatment options, and/or outcomes in various subgroups of patients such as defined by demographics, comorbidities, indications and symptoms, treatment variables, and/or outcome variables.

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Observational
Observational Model: Cohort
Time Perspective: Prospective
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Probability Sample

All patients who are evaluated and scheduled to undergo surgical treatment for a spine-related condition are eligible to participate in this registry.

  • Vertebra; Degeneration
  • Spinal Trauma
  • Spinal Deformity
Procedure: Surgery
Patients will receive standard of care surgical treatment dependent on his/her spinal condition.
  • Degenerative
    Patients being treated for degenerative spine conditions.
    Intervention: Procedure: Surgery
  • Deformity
    Patients being treated for a deformity spine condition.
    Intervention: Procedure: Surgery
  • Trauma
    Patients being treated for a trauma related spine condition.
    Intervention: Procedure: Surgery
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Enrolling by invitation
10000
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December 2023   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Candidate for spinal surgery
Both
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No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01372592
NUVA.REG1101
No
NuVasive
NuVasive
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NuVasive
February 2014

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