Clinical trial NCT01372592: SpineTRACK Registry - Spinal Outcomes Registry
Official title: SpineTRACK (Translating Radiographic and Clinical Knowledge) Registry: Outcomes Data Collection in Degenerative, Deformity, and Trauma Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Vertebra; Degeneration
Spinal Trauma
Spinal Deformity
Lead sponsor: NuVasive
Sponsor class: INDUSTRY
First posted: 2011-06-14
Enrollment: 8079
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

Brief 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.


Eligibility criteria: Inclusion Criteria:

* Candidate for spinal surgery

Primary outcomes:
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.
timeFrame: 24 months then annually thereafter
Secondary outcomes:
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Spine Group Arizona
state: Arizona
city: La Jolla
country: United States
facility: SD Center for Spinal Disorders
state: California
city: Orange
country: United States
facility: Orthopaedic Specialty Institute
state: California
city: San Francisco
country: United States
facility: UCSF Dept. of Orthopaedic Surgery
state: California
city: Durango
country: United States
facility: Durango Orthopaedics
state: Colorado
city: Tampa
country: United States
facility: University of South Florida Department of Neurosurgery, Tampa General Hospital
state: Florida
city: Atlanta
country: United States
facility: Piedmont Physicians
state: Georgia
city: Chicago
country: United States
facility: Midwest Orthopaedics at Rush University
state: Illinois
city: Indianapolis
country: United States
facility: OrthoIndy Northwest
state: Indiana
city: Minneapolis
country: United States
facility: University of Minnesota Medical
state: Minnesota
city: Jefferson City
country: United States
facility: Spine Midwest
state: Missouri
city: Saint Louis
country: United States
facility: Spinemore, LLC
state: Missouri
city: Las Vegas
country: United States
facility: Western Regional Center for Brain & Spine Surgery, Surgery Center of S. Nevada
state: Nevada
city: Toms River
country: United States
facility: Ocean Orthopaedics
state: New Jersey
city: Buffalo
country: United States
facility: University of Buffalo
state: New York
city: Eden
country: United States
facility: Morehead NeuroSpine
state: North Carolina
city: Raleigh
country: United States
facility: Bone & Joint Surgery Clinic
state: North Carolina
city: Raleigh
country: United States
facility: Wake Orthopaedics
state: North Carolina
city: Eugene
country: United States
facility: NeuroSpine Institute
state: Oregon
city: Medford
country: United States
facility: Team2 Solutions, LLC
state: Oregon
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center
state: Pennsylvania
city: Houston
country: United States
facility: Houston Methodist Orthopedics & Sports Medicine
state: Texas
city: Lakeway
country: United States
facility: Austin Spine
state: Texas
city: Salt Lake City
country: United States
facility: Salt Lake Orthopedic Clinic
state: Utah
city: Puyallup
country: United States
facility: NeoSpine
state: Washington
city: Spokane
country: United States
facility: Northwest Orthopaedic Specialists, PS
state: Washington
city: Sao Paulo
country: Brazil
facility: Luis Pimenta, MD
state: BR
city: Minas Gerais
country: Brazil
facility: Hospital Ortopedico
Study officials:
affiliation: NuVasive
name: Kyle Malone, MS
role: STUDY_DIRECTOR
References: