Prospective SPINE Registry (SPINE)

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: Recruiting
• Conditions: Joint Diseases; Musculoskeletal Diseases; Spinal Stenosis; Fusion of Spine; Spine; Spinal Fusion; Spinal Disease; Spinal Instability; Sacroiliac; Fusion; Fusion of Joint; Sacroiliac
• Intervention / Treatment: Device: RTI Spine products

• Study Type: Observational
• Enrollment (Estimated): 5000

Contacts and Locations

• Study Contact: Name: Isabella M Rosales, BS; Phone Number: 406-924-5884; Email: irosales@xtantmedical.com
• Study Contact Backup: Name: Laura Henderson; Phone Number: 406-813-4107; Email: lhenderson@xtantmedical.com

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    • Withdrawn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    • Withdrawn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    • Withdrawn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      • Withdrawn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

Eligibility Criteria

• 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

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intervention Rates	Rates of reoperation and/or revision procedures at index level	1 month, 3 months, 6 months, 12 months, and 24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fusion	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	Change in radiographic findings	1 month, 3 months, 6 months, 12 months, and 24 months
Adverse Events	Number of procedure and device related adverse events	1 month, 3 months, 6 months, 12 months, and 24 months
Disability (Cervical)	Change in Neck Disability Index	1 month, 3 months, 6 months, 12 months, and 24 months
Disability (non-Cervical)	Change in Oswestry Disability Index	1 month, 3 months, 6 months, 12 months, and 24 months
Pain Change	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 to first reoperation and/or revision procedure at index leve	1 month, 3 months, 6 months, 12 months, and 24 months

Collaborators and Investigators

• Sponsor: Xtant Medical
• Collaborators: RTI Surgical

Study record dates

Study Major Dates

• Study Start (Actual): January 28, 2020
• Primary Completion (Estimated): March 1, 2025
• Study Completion (Estimated): June 1, 2025

Study Registration Dates

• First Submitted: November 20, 2019
• First Submitted That Met QC Criteria: November 21, 2019
• First Posted (Actual): November 25, 2019

Study Record Updates

• Last Update Posted (Actual): March 12, 2024
• Last Update Submitted That Met QC Criteria: March 8, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Bone Diseases; Joint Diseases; Musculoskeletal Diseases; Spinal Diseases; Spinal Stenosis
• Other Study ID 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