Prospective SPINE Registry

Musculoskeletal Diseases Clinical Trial

— SPINE  

Official title:

Prospective Study on Safety and Performance of Surgalign spINE Products

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04176562
• Other study ID #: 19094
• Status: Recruiting
• Start date: January 28, 2020
• Est. completion date: June 2025

Study information

• Verified date: March 2024
• Source: Xtant Medical
• Contact: Isabella M Rosales, BS
• Phone: 406-924-5884
• Email: irosales[@]xtantmedical.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 5000
• Est. completion date: June 2025
• Est. primary completion date: March 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

Device:
• 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.

Locations

Country	Name	City	State
Germany	STENUM Ortho Fachklinik	Ganderkesee
Germany	Wirbelsäulenzentrum Fulda | Main | Kinzig	Gelnhausen
Germany	Katholisches Klinikum Koblenz - Montabaur	Koblenz
Germany	St. Christopherus Krankenhaus - Katholisches Klinikum	Werne
Spain	Hospital Nacional de Parapléjicos	Toledo
United States	Suburban Orthopaedics	Bartlett	Illinois
United States	Florida Back Institute	Boca Raton	Florida
United States	Indiana Spine Group	Carmel	Indiana
United States	Lindner Center for Research & Education at The Christ Hospit	Cincinnati	Ohio
United States	DK Orthopedics	Crown Point	Indiana
United States	Spine Institute of South Florida	Delray Beach	Florida
United States	Hartford Hospital	Hartford	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
Xtant Medical

Countries where clinical trial is conducted

United States,  Germany,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intervention Rates	Rates of reoperation and/or revision procedures at index level	1 month, 3 months, 6 months, 12 months, and 24 months
Secondary	Fusion	Fusion success measures by radiological assessment (x-ray, CT scan, MRI, etc.)	1 month, 3 months, 6 months, 12 months, and 24 months
Secondary	Radiographic Findings	Change in radiographic findings	1 month, 3 months, 6 months, 12 months, and 24 months
Secondary	Adverse Events	Number of procedure and device related adverse events	1 month, 3 months, 6 months, 12 months, and 24 months
Secondary	Disability (Cervical)	Change in Neck Disability Index	1 month, 3 months, 6 months, 12 months, and 24 months
Secondary	Disability (non-Cervical)	Change in Oswestry Disability Index	1 month, 3 months, 6 months, 12 months, and 24 months
Secondary	Pain Change	Change in pain as determined by Visual Analogue Scale (VAS)	1 month, 3 months, 6 months, 12 months, and 24 months
Secondary	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