Prospective SPINE Registry

NCT04176562 | Recruiting FDA Device

• 1 other identifier: 19094
• Study Type: observational
• Target: 5,000
• Locations: 3 countries
• Sites: 12

Brief Summary

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.

Conditions

Sacroiliac; Fusion; Sacroiliac; Joint Diseases; Musculoskeletal Diseases; Spinal Disease; Spinal Stenosis; Spinal Instability; Fusion of Joint; Fusion of Spine; Spinal Fusion; Spine

Outcome Measures

Primary Outcomes (1)

• Intervention Rates

  Rates of reoperation and/or revision procedures at index level

  1 month, 3 months, 6 months, 12 months, and 24 months

Secondary Outcomes (7)

• Fusion

  1 month, 3 months, 6 months, 12 months, and 24 months

• Radiographic Findings

  1 month, 3 months, 6 months, 12 months, and 24 months

• Adverse Events

  1 month, 3 months, 6 months, 12 months, and 24 months

• Disability (Cervical)

  1 month, 3 months, 6 months, 12 months, and 24 months

• Disability (non-Cervical)

  1 month, 3 months, 6 months, 12 months, and 24 months

Interventions

RTI Spine products DEVICE

* Interbody fusion devices - intended to help facilitate fusion by providing a platform for bone growth, while maintaining height and decompression. * Supplemental fixation and/or stabilization devices - are intended to stabilize the spine to allow for fusion to occur, maintain current spinal movement, correct deformities or curvature, treat trauma, spinal stenosis, tumor and pseudarthrosis. * Bone graft substitute - is intended to aid in fusion.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• Patient who is, or is expected to be inaccessible for follow-up.
• 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.

Sponsors & Collaborators

• Xtant Medical: lead

Study Sites (12)

Hartford Hospital

Hartford, Connecticut, 06102, United States

ACTIVE NOT RECRUITING

Florida Back Institute

Boca Raton, Florida, 33496, United States

ACTIVE NOT RECRUITING

Spine Institute of South Florida

Delray Beach, Florida, 33484, United States

ACTIVE NOT RECRUITING

Suburban Orthopaedics

Bartlett, Illinois, 60103, United States

TERMINATED

Indiana Spine Group

Carmel, Indiana, 46032, United States

WITHDRAWN

DK Orthopedics

Crown Point, Indiana, 46307, United States

COMPLETED

Lindner Center for Research & Education at The Christ Hospit

Cincinnati, Ohio, 45219, United States

ACTIVE NOT RECRUITING

STENUM Ortho Fachklinik

Ganderkesee, 27777, Germany

WITHDRAWN

Wirbelsäulenzentrum Fulda | Main | Kinzig

Gelnhausen, 63571, Germany

ACTIVE NOT RECRUITING

Katholisches Klinikum Koblenz - Montabaur

Koblenz, D-56073, Germany

WITHDRAWN

St. Christopherus Krankenhaus - Katholisches Klinikum

Werne, 59368, Germany

WITHDRAWN

Hospital Nacional de Parapléjicos

Toledo, 45004, Spain

RECRUITING

MeSH Terms

Conditions

Joint Diseases; Musculoskeletal Diseases; Spinal Diseases; Spinal Stenosis; Ankylosis

Condition Hierarchy (Ancestors)

Bone Diseases

Central Study Contacts

Isabella M Rosales, BS

CONTACT

406-924-5884; irosales@xtantmedical.com

Laura Henderson

CONTACT

406-813-4107; lhenderson@xtantmedical.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 20, 2019
• First Posted: November 25, 2019
• Study Start: January 28, 2020
• Primary Completion: March 1, 2025
• Study Completion: June 1, 2025
• Last Updated: March 12, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1); DE (4); US (7)