SpineTRACK Registry - Spinal Outcomes Registry

Spinal Deformity Clinical Trial

Official title:

SpineTRACK (Translating Radiographic and Clinical Knowledge) Registry: Outcomes Data Collection in Degenerative, Deformity, and Trauma Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01372592
• Other study ID #: NUVA.REG1101
• Status: Completed
• Start date: March 2011
• Est. completion date: December 6, 2016

Study information

• Verified date: December 2018
• Source: NuVasive
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The Spine TRACK 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8079
• Est. completion date: December 6, 2016
• Est. primary completion date: December 6, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Candidate for spinal surgery

Related Conditions & MeSH terms

• Congenital Abnormalities
• Spinal Deformity
• Spinal Trauma
• Vertebra; Degeneration

Intervention

Procedure:
• Surgery
Patients will receive standard of care surgical treatment dependent on his/her spinal condition.

Locations

Country	Name	City	State
Brazil	Hospital Ortopedico	Minas Gerais
Brazil	Luis Pimenta, MD	Sao Paulo	BR
United States	Piedmont Physicians	Atlanta	Georgia
United States	University of Buffalo	Buffalo	New York
United States	Midwest Orthopaedics at Rush University	Chicago	Illinois
United States	Durango Orthopaedics	Durango	Colorado
United States	Morehead NeuroSpine	Eden	North Carolina
United States	NeuroSpine Institute	Eugene	Oregon
United States	Houston Methodist Orthopedics & Sports Medicine	Houston	Texas
United States	OrthoIndy Northwest	Indianapolis	Indiana
United States	Spine Midwest	Jefferson City	Missouri
United States	SD Center for Spinal Disorders	La Jolla	California
United States	Austin Spine	Lakeway	Texas
United States	Western Regional Center for Brain & Spine Surgery, Surgery Center of S. Nevada	Las Vegas	Nevada
United States	Team2 Solutions, LLC	Medford	Oregon
United States	University of Minnesota Medical	Minneapolis	Minnesota
United States	Orthopaedic Specialty Institute	Orange	California
United States	Spine Group Arizona	Phoenix	Arizona
United States	University of Pittsburgh Medical Center	Pittsburgh	Pennsylvania
United States	NeoSpine	Puyallup	Washington
United States	Bone & Joint Surgery Clinic	Raleigh	North Carolina
United States	Wake Orthopaedics	Raleigh	North Carolina
United States	Spinemore, LLC	Saint Louis	Missouri
United States	Salt Lake Orthopedic Clinic	Salt Lake City	Utah
United States	UCSF Dept. of Orthopaedic Surgery	San Francisco	California
United States	Northwest Orthopaedic Specialists, PS	Spokane	Washington
United States	University of South Florida Department of Neurosurgery, Tampa General Hospital	Tampa	Florida
United States	Ocean Orthopaedics	Toms River	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
NuVasive

Countries where clinical trial is conducted

United States,  Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To create a database of radiographic and clinical outcome measures of spinal surgery patients to evaluate the efficacy of various procedures for multiple diagnoses.		24 months then annually thereafter

External Links

•   Link