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: July 14, 2014
Last verified: July 2014
  Purpose

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.


Condition Intervention
Vertebra; Degeneration
Spinal Trauma
Spinal Deformity
Procedure: Surgery

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: SOLAS® Spinal Surgery Registry: Prospective Clinical and Radiographic Outcomes Data Collection in Degenerative, Deformity, and Trauma Patients

Resource links provided by NLM:


Further study details as provided by NuVasive:

Primary Outcome Measures:
  • 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 ]

Estimated Enrollment: 10000
Study Start Date: March 2011
Estimated Primary Completion Date: December 2023 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Degenerative
Patients being treated for degenerative spine conditions.
Procedure: Surgery
Patients will receive standard of care surgical treatment dependent on his/her spinal condition.
Deformity
Patients being treated for a deformity spine condition.
Procedure: Surgery
Patients will receive standard of care surgical treatment dependent on his/her spinal condition.
Trauma
Patients being treated for a trauma related spine condition.
Procedure: Surgery
Patients will receive standard of care surgical treatment dependent on his/her spinal condition.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

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

Criteria

Inclusion Criteria:

  • Candidate for spinal surgery
  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: NCT01372592

  Show 23 Study Locations
Sponsors and Collaborators
NuVasive
  More Information

Additional Information:
No publications provided

Responsible Party: NuVasive
ClinicalTrials.gov Identifier: NCT01372592     History of Changes
Other Study ID Numbers: NUVA.REG1101
Study First Received: March 25, 2011
Last Updated: July 14, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Congenital Abnormalities
Wounds and Injuries

ClinicalTrials.gov processed this record on July 31, 2014