Clinical trial NCT04176562: Prospective SPINE Registry
Official title: Prospective Study on Safety and Performance of Surgalign spINE Products
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Sacroiliac; Fusion
Sacroiliac
Joint Diseases
Musculoskeletal Diseases
Spinal Disease
Spinal Stenosis
Spinal Instability
Fusion of Joint
Fusion of Spine
Spinal Fusion
Spine
Lead sponsor: Xtant Medical
Sponsor class: INDUSTRY
First posted: 2019-11-25
Enrollment: 5000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients that have spinal problems requiring treatment with an RTI Surgical spine product.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Intervention Rates
timeFrame: 1 month, 3 months, 6 months, 12 months, and 24 months
Secondary outcomes:
measure: Fusion
timeFrame: 1 month, 3 months, 6 months, 12 months, and 24 months
measure: Radiographic Findings
timeFrame: 1 month, 3 months, 6 months, 12 months, and 24 months
measure: Adverse Events
timeFrame: 1 month, 3 months, 6 months, 12 months, and 24 months
measure: Disability (Cervical)
timeFrame: 1 month, 3 months, 6 months, 12 months, and 24 months
measure: Disability (non-Cervical)
timeFrame: 1 month, 3 months, 6 months, 12 months, and 24 months
measure: Pain Change
timeFrame: 1 month, 3 months, 6 months, 12 months, and 24 months
measure: Time to Intervention
timeFrame: 1 month, 3 months, 6 months, 12 months, and 24 months
Other outcomes:
Locations:
city: Hartford
country: United States
facility: Hartford Hospital
state: Connecticut
city: Boca Raton
country: United States
facility: Florida Back Institute
state: Florida
city: Delray Beach
country: United States
facility: Spine Institute of South Florida
state: Florida
city: Bartlett
country: United States
facility: Suburban Orthopaedics
state: Illinois
city: Carmel
country: United States
facility: Indiana Spine Group
state: Indiana
city: Crown Point
country: United States
facility: DK Orthopedics
state: Indiana
city: Cincinnati
country: United States
facility: Lindner Center for Research & Education at The Christ Hospit
state: Ohio
city: Ganderkesee
country: Germany
facility: STENUM Ortho Fachklinik
city: Gelnhausen
country: Germany
facility: Wirbelsäulenzentrum Fulda | Main | Kinzig
city: Koblenz
country: Germany
facility: Katholisches Klinikum Koblenz - Montabaur
city: Werne
country: Germany
facility: St. Christopherus Krankenhaus - Katholisches Klinikum
city: Toledo
country: Spain
facility: Hospital Nacional de Parapléjicos
Study officials:
References: