SOLAS® Spinal Surgery Registry
This study is enrolling participants by invitation only.
Sponsor:
NuVasive
Information provided by (Responsible Party):
NuVasive
ClinicalTrials.gov Identifier:
NCT01372592
First received: March 25, 2011
Last updated: October 19, 2012
Last verified: October 2012
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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 |
| 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01372592
Locations
| United States, Colorado | |
| Durango Orthopaedics | |
| Durango, Colorado, United States, 81301 | |
| United States, Florida | |
| University of South Florida Department of Neurosurgery, Tampa General Hospital | |
| Tampa, Florida, United States, 33606 | |
| United States, Georgia | |
| Georgia Spine and Neurosurgery Center | |
| Atlanta, Georgia, United States, 30033 | |
| Pinnacle Orthopedics & Sports Medicine Specialists | |
| Marrietta, Georgia, United States, 30060 | |
| United States, Illinois | |
| Midwest Orthopaedics at Rush University | |
| Chicago, Illinois, United States, 60612 | |
| United States, Missouri | |
| Spine Midwest | |
| Jefferson City, Missouri, United States, 65101 | |
| United States, Nevada | |
| Western Regional Center for Brain & Spine Surgery, Surgery Center of S. Nevada | |
| Las Vegas, Nevada, United States, 89109 | |
| United States, North Carolina | |
| Duke University Medical Center | |
| Durham, North Carolina, United States, 27710 | |
| United States, Oregon | |
| The NeuroSpine Institute | |
| Eugene, Oregon, United States, 97401 | |
| Southern Oregon Orthopaedics | |
| Medford, Oregon, United States, 97504 | |
| United States, Pennsylvania | |
| University of Pittsburgh Medical Center | |
| Pittsburgh, Pennsylvania, United States, 15213 | |
| United States, Texas | |
| Spine Pain Be Gone | |
| San Antonio, Texas, United States, 78229 | |
| United States, Utah | |
| Salt Lake Orthopaedic Clinic | |
| Salt Lake, Utah, United States, 84124 | |
| United States, Washington | |
| South Sound Neurosurgery | |
| Puyallup, Washington, United States, 98372 | |
| Northwest Orthopaedic Specialists, PS | |
| Spokane, Washington, United States, 99208 | |
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: | October 19, 2012 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Congenital Abnormalities Wounds and Injuries |
ClinicalTrials.gov processed this record on May 23, 2013