Prospective SPINE Registry

NCT ID: NCT04176562

Last Updated: 2024-03-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

5000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-01-28

Study Completion Date

2025-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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RTI Spine products

* 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.

Intervention Type DEVICE

Eligibility Criteria

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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.
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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Xtant Medical

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Hartford Hospital

Hartford, Connecticut, United States

Site Status ACTIVE_NOT_RECRUITING

Florida Back Institute

Boca Raton, Florida, United States

Site Status ACTIVE_NOT_RECRUITING

Spine Institute of South Florida

Delray Beach, Florida, United States

Site Status ACTIVE_NOT_RECRUITING

Suburban Orthopaedics

Bartlett, Illinois, United States

Site Status TERMINATED

Indiana Spine Group

Carmel, Indiana, United States

Site Status WITHDRAWN

DK Orthopedics

Crown Point, Indiana, United States

Site Status COMPLETED

Lindner Center for Research & Education at The Christ Hospit

Cincinnati, Ohio, United States

Site Status ACTIVE_NOT_RECRUITING

STENUM Ortho Fachklinik

Ganderkesee, , Germany

Site Status WITHDRAWN

Wirbelsäulenzentrum Fulda | Main | Kinzig

Gelnhausen, , Germany

Site Status ACTIVE_NOT_RECRUITING

Katholisches Klinikum Koblenz - Montabaur

Koblenz, , Germany

Site Status WITHDRAWN

St. Christopherus Krankenhaus - Katholisches Klinikum

Werne, , Germany

Site Status WITHDRAWN

Hospital Nacional de Parapléjicos

Toledo, , Spain

Site Status RECRUITING

Countries

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United States Germany Spain

Central Contacts

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Isabella M Rosales, BS

Role: CONTACT

406-924-5884

Laura Henderson

Role: CONTACT

406-813-4107

Facility Contacts

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María Elena Alonso

Role: primary

34 925 24 77 00

Other Identifiers

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19094

Identifier Type: -

Identifier Source: org_study_id

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