Prospective SPINE Registry (SPINE)

March 8, 2024 updated by: Xtant Medical

Prospective Study on Safety and Performance of Surgalign spINE Products

This study is a prospective, multi-center, open label registry designed to collect real-world data on performance and safety data on RTI's spine products.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
5000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Germany
      • Ganderkesee, Germany, 27777
        • Withdrawn
        • STENUM Ortho Fachklinik
      • Gelnhausen, Germany, 63571
        • Active, not recruiting
        • Wirbelsäulenzentrum Fulda | Main | Kinzig
      • Koblenz, Germany, D-56073
        • Withdrawn
        • Katholisches Klinikum Koblenz - Montabaur
      • Werne, Germany, 59368
        • Withdrawn
        • St. Christopherus Krankenhaus - Katholisches Klinikum
  • Spain
      • Toledo, Spain, 45004
        • Recruiting
        • Hospital Nacional de Parapléjicos
        • Contact:
          • María Elena Alonso
          • Phone Number: 34 925 24 77 00
  • United States
    • Connecticut
      • Hartford, Connecticut, United States, 06102
        • Active, not recruiting
        • Hartford Hospital
    • Florida
      • Boca Raton, Florida, United States, 33496
        • Active, not recruiting
        • Florida Back Institute
      • Delray Beach, Florida, United States, 33484
        • Active, not recruiting
        • Spine Institute of South Florida
    • Illinois
      • Bartlett, Illinois, United States, 60103
        • Terminated
        • Suburban Orthopaedics
    • Indiana
      • Carmel, Indiana, United States, 46032
        • Withdrawn
        • Indiana Spine Group
      • Crown Point, Indiana, United States, 46307
        • Completed
        • DK Orthopedics
    • Ohio
      • Cincinnati, Ohio, United States, 45219
        • Active, not recruiting
        • Lindner Center for Research & Education at The Christ Hospit

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients that have spinal problems requiring treatment with an RTI Surgical spine product.

Description

Inclusion Criteria:

  1. Candidate for RTI spine product.
  2. Willing and able to consent to the study.

Exclusion Criteria:

  1. Patient who is, or is expected to be inaccessible for follow-up.
  2. Patient meets any exclusion criteria required by local law (e.g. age, mental capacity, etc.).
  3. Other concurrent medical or other condition (chronic or acute in nature) that in the opinion of the investigator may prevent participation or otherwise render patient ineligible for the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Intervention Rates
Time Frame: 1 month, 3 months, 6 months, 12 months, and 24 months
Rates of reoperation and/or revision procedures at index level
1 month, 3 months, 6 months, 12 months, and 24 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Fusion
Time Frame: 1 month, 3 months, 6 months, 12 months, and 24 months
Fusion success measures by radiological assessment (x-ray, CT scan, MRI, etc.)
1 month, 3 months, 6 months, 12 months, and 24 months
Radiographic Findings
Time Frame: 1 month, 3 months, 6 months, 12 months, and 24 months
Change in radiographic findings
1 month, 3 months, 6 months, 12 months, and 24 months
Adverse Events
Time Frame: 1 month, 3 months, 6 months, 12 months, and 24 months
Number of procedure and device related adverse events
1 month, 3 months, 6 months, 12 months, and 24 months
Disability (Cervical)
Time Frame: 1 month, 3 months, 6 months, 12 months, and 24 months
Change in Neck Disability Index
1 month, 3 months, 6 months, 12 months, and 24 months
Disability (non-Cervical)
Time Frame: 1 month, 3 months, 6 months, 12 months, and 24 months
Change in Oswestry Disability Index
1 month, 3 months, 6 months, 12 months, and 24 months
Pain Change
Time Frame: 1 month, 3 months, 6 months, 12 months, and 24 months
Change in pain as determined by Visual Analogue Scale (VAS)
1 month, 3 months, 6 months, 12 months, and 24 months
Time to Intervention
Time Frame: 1 month, 3 months, 6 months, 12 months, and 24 months
Time to first reoperation and/or revision procedure at index leve
1 month, 3 months, 6 months, 12 months, and 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Xtant Medical

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
RTI Surgical

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 28, 2020

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 20, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 21, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 25, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 12, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 8, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 19094

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

There is no plan to share IPD

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings