Vertebra; DegenerationNCT01372592
SpineTRACK Registry - Spinal Outcomes Registry
An observational study of Vertebra; Degeneration and Spinal Trauma, run by NuVasive at 28 sites in 2 countries.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Vertebra; Degeneration, Spinal Trauma, Spinal Deformity
- What is being tested?
- Surgery
- Type of treatment
- Surgery or procedure
- How many people
- 8,079 participants
- Where
- 28 sitesin 2 countries
- Study dates
- Mar 2011to 6 Dec 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- Candidate for spinal surgery
Who cannot join
None listed.
Trial locations and contacts
28 sites in 2 countries.
28 sites in 2 countries
United States26 sites
Piedmont Physicians
Atlanta, Georgia, 30309
University of Buffalo
Buffalo, New York, 14203
Midwest Orthopaedics at Rush University
Chicago, Illinois, 60612
Durango Orthopaedics
Durango, Colorado, 81301
Morehead NeuroSpine
Eden, North Carolina, 27288
NeuroSpine Institute
Eugene, Oregon, 97401
Houston Methodist Orthopedics & Sports Medicine
Houston, Texas, 77030
OrthoIndy Northwest
Indianapolis, Indiana, 46278
Spine Midwest
Jefferson City, Missouri, 65101
SD Center for Spinal Disorders
La Jolla, California, 92037
Austin Spine
Lakeway, Texas, 78738
Western Regional Center for Brain & Spine Surgery, Surgery Center of S. Nevada
Las Vegas, Nevada, 89109
Team2 Solutions, LLC
Medford, Oregon, 97504
University of Minnesota Medical
Minneapolis, Minnesota, 55454
Orthopaedic Specialty Institute
Orange, California, 92868
Spine Group Arizona
Phoenix, Arizona, 85251
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213
NeoSpine
Puyallup, Washington, 98372
Bone & Joint Surgery Clinic
Raleigh, North Carolina, 27609
Wake Orthopaedics
Raleigh, North Carolina, 27610
Salt Lake Orthopedic Clinic
Salt Lake City, Utah, 84124
UCSF Dept. of Orthopaedic Surgery
San Francisco, California, 94143
Northwest Orthopaedic Specialists, PS
Spokane, Washington, 99208
Spinemore, LLC
St Louis, Missouri, 63128
University of South Florida Department of Neurosurgery, Tampa General Hospital
Tampa, Florida, 33606
Ocean Orthopaedics
Tomas River, New Jersey, 08755
About this study
Official title: SpineTRACK (Translating Radiographic and Clinical Knowledge) Registry: Outcomes Data Collection in Degenerative, Deformity, and Trauma Patients
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.
- Conditions
- Vertebra; Degeneration, Spinal Trauma, Spinal Deformity
- Being tested
- Surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SurgeryProcedure or surgery
Patients will receive standard of care surgical treatment dependent on his/her spinal condition.
| Study group | Role | What they receive |
|---|---|---|
| Degenerative | Patients being treated for degenerative spine conditions. Receives: Procedure: Surgery | |
| Deformity | Patients being treated for a deformity spine condition. Receives: Procedure: Surgery | |
| Trauma | Patients being treated for a trauma related spine condition. Receives: Procedure: Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
To create a database of radiographic and clinical outcome measures of spinal surgery patients to evaluate the efficacy of various procedures for multiple diagnoses.
Measured: 24 months then annually thereafter
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2011 (estimated)
- Study startMar 2011
- Primary completion6 Dec 2016
- Study completion6 Dec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vertebra; DegenerationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 8,079 participants (actual)
Sponsor and investigators
- Lead sponsor
- NuVasive
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kyle Malone, MS, Study director, NuVasive
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01372592
- Sponsor's protocol ID
- NUVA.REG1101
- Status last verified
- Dec 2025
- First submitted
- 25 Mar 2011
- Last updated
- 24 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SpineTRACK (Translating Radiographic and Clinical Knowledge) Registry: Outcomes Data Collection in Degenerative, Deformity, and Trauma Patients
- ClinicalTrials.gov ID
- NCT01372592
- Acronym / sponsor ID
- NUVA.REG1101
- Conditions
- Vertebra; Degeneration, Spinal Trauma, Spinal Deformity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 8,079 participants (actual)
- Lead sponsor
- NuVasiveIndustry (pharma, biotech, devices)
- Study start
- Mar 2011
- Primary completion
- 6 Dec 2016 (actual)
- Study completion
- 6 Dec 2016 (actual)
- First posted
- 14 Jun 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Degenerative | – | Procedure: SurgeryPatients being treated for degenerative spine conditions. |
| Deformity | – | Procedure: SurgeryPatients being treated for a deformity spine condition. |
| Trauma | – | Procedure: SurgeryPatients being treated for a trauma related spine condition. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- Candidate for spinal surgery
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SurgeryPatients will receive standard of care surgical treatment dependent on his/her spinal condition. | Procedure or surgery | Deformity, Degenerative, Trauma |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2025.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kyle Malone, MS study director
NuVasive
28 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Vertebra; Degeneration and Spinal Trauma, run by NuVasive at 28 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 28 sites in United States, Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Dec 2025.