Sacroiliac; FusionSPINENCT04176562
Prospective SPINE Registry
An observational study of Sacroiliac; Fusion and Sacroiliac, run by Xtant Medical at 12 sites in 3 countries.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sacroiliac; Fusion, Sacroiliac, Joint Diseases
- What is being tested?
- RTI Spine products
- Type of treatment
- Medical device
- How many people
- 5,000 participants
- Where
- 12 sitesin 3 countries
- Study dates
- 28 Jan 2020to Jun 2025
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients that have spinal problems requiring treatment with an RTI Surgical spine product.
Who may be able to join
- Candidate for RTI spine product.
- Willing and able to consent to the study.
Who cannot join
- Patient who is, or is expected to be inaccessible for follow-up.
- Patient meets any exclusion criteria required by local law (e.g. age, mental capacity, etc.).
- 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.
Trial locations and contacts
12 sites in 3 countries.
12 sites in 3 countries
United States7 sites
- Terminated
Suburban Orthopaedics
Bartlett, Illinois, 60103
- Active, not recruiting
Florida Back Institute
Boca Raton, Florida, 33496
- Withdrawn
Indiana Spine Group
Carmel, Indiana, 46032
- Active, not recruiting
Lindner Center for Research & Education at The Christ Hospit
Cincinnati, Ohio, 45219
- Completed
DK Orthopedics
Crown Point, Indiana, 46307
- Active, not recruiting
Spine Institute of South Florida
Delray Beach, Florida, 33484
- Active, not recruiting
Hartford Hospital
Hartford, Connecticut, 06102
Germany4 sites
- Withdrawn
STENUM Ortho Fachklinik
Ganderkesee, 27777
- Active, not recruiting
Wirbelsäulenzentrum Fulda | Main | Kinzig
Gelnhausen, 63571
- Withdrawn
Katholisches Klinikum Koblenz - Montabaur
Koblenz, D-56073
- Withdrawn
St. Christopherus Krankenhaus - Katholisches Klinikum
Werne, 59368
Spain1 site, 1 recruiting
- Recruiting
Hospital Nacional de Parapléjicos
Toledo, 45004
María Elena Alonso, 34 925 24 77 00
About this study
Official title: 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.
- Conditions
- Sacroiliac; Fusion, Sacroiliac, Joint Diseases, Musculoskeletal Diseases, Spinal Disease, Spinal Stenosis
- Being tested
- RTI Spine products
- Medical subject headings
- Joint Diseases, Musculoskeletal Diseases, Spinal Diseases, Spinal Stenosis, Ankylosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RTI Spine productsDevice
- 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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Intervention Rates
Rates of reoperation and/or revision procedures at index level
Measured: 1 month, 3 months, 6 months, 12 months, and 24 months
Secondary outcomes (7)
Fusion
Fusion success measures by radiological assessment (x-ray, CT scan, MRI, etc.)
Measured: 1 month, 3 months, 6 months, 12 months, and 24 months
Radiographic Findings
Change in radiographic findings
Measured: 1 month, 3 months, 6 months, 12 months, and 24 months
Adverse Events
Number of procedure and device related adverse events
Measured: 1 month, 3 months, 6 months, 12 months, and 24 months
Disability (Cervical)
Change in Neck Disability Index
Measured: 1 month, 3 months, 6 months, 12 months, and 24 months
Disability (non-Cervical)
Change in Oswestry Disability Index
Measured: 1 month, 3 months, 6 months, 12 months, and 24 months
Pain Change
Change in pain as determined by Visual Analogue Scale (VAS)
Measured: 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
Measured: 1 month, 3 months, 6 months, 12 months, and 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2019
- Study start28 Jan 2020
- Primary completionMar 2025 (estimated)
- Study completionJun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sacroiliac; FusionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 5,000 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Xtant Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04176562
- Sponsor's protocol ID
- 19094
- Acronym
- SPINE
- Status last verified
- Mar 2024
- First submitted
- 20 Nov 2019
- Last updated
- 12 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: There is no plan to share IPD
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Study on Safety and Performance of Surgalign spINE Products
- ClinicalTrials.gov ID
- NCT04176562
- Acronym / sponsor ID
- SPINE / 19094
- Conditions
- Sacroiliac; Fusion, Sacroiliac, Joint Diseases, Musculoskeletal Diseases, Spinal Disease, Spinal Stenosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 5,000 participants (estimated)
- Lead sponsor
- Xtant MedicalIndustry (pharma, biotech, devices)
- Study start
- 28 Jan 2020 (actual)
- Primary completion
- Mar 2025 (estimated)
- Study completion
- Jun 2025 (estimated)
- First posted
- 25 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients that have spinal problems requiring treatment with an RTI Surgical spine product.
Key inclusion criteria (2 listed)
- Candidate for RTI spine product.
- Willing and able to consent to the study.
Key exclusion criteria (3 listed)
- Patient who is, or is expected to be inaccessible for follow-up.
- Patient meets any exclusion criteria required by local law (e.g. age, mental capacity, etc.).
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | – |
Primary outcome
Intervention Rates
Time frame: 1 month, 3 months, 6 months, 12 months, and 24 months
Rates of reoperation and/or revision procedures at index level
7 secondary outcomes
Fusion
Time frame: 1 month, 3 months, 6 months, 12 months, and 24 months
Radiographic Findings
Time frame: 1 month, 3 months, 6 months, 12 months, and 24 months
Adverse Events
Time frame: 1 month, 3 months, 6 months, 12 months, and 24 months
Disability (Cervical)
Time frame: 1 month, 3 months, 6 months, 12 months, and 24 months
Disability (non-Cervical)
Time frame: 1 month, 3 months, 6 months, 12 months, and 24 months
Pain Change
Time frame: 1 month, 3 months, 6 months, 12 months, and 24 months
Time to Intervention
Time frame: 1 month, 3 months, 6 months, 12 months, and 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2024.
- Individual participant dataSharing planned: No. There is no plan to share IPD
Related trials for Sacroiliac; Fusion
Enrolling by invitationObservational study
Sacroiliac Joint Fusion Intervention For Mobility, Pain Relief, and Lasting Improvement in Functional Recovery "SIMPLIFY"
Degenerative Sacroiliitis, Sacroiliac Disorder
RecruitingPhase 4
LINQ® Procedure vs. Conventional Medical Management for Sacroiliac Dysfunction
Sacroiliac Joint Pain
RecruitingObservational study
Real World Evidence of SI-BONE's iFuse TORQ TNT Advancing Treatment of Pelvic Ring Fractures
Fracture; Pelvic, Insufficiency Fractures
Active, not recruitingPhase 4
iFuse TORQ for the Treatment of Sacroiliac Joint Dysfunction
Sacroiliac Joint Dysfunction, Sacroiliac; Fusion
Not yet recruitingObservational study
Posterior-Inferior Intra-articular Cortical Piercing Titanium Implant for Sacroiliac Joint Fusion: Evaluation of Safety and Effectiveness Outcomes
Sacro Iliac Joint Pain, Sacro-iliac Joints
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
12 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sacroiliac; Fusion and Sacroiliac, run by Xtant Medical at 12 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in United States, Germany, Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Isabella M Rosales, BS (406-924-5884, irosales@xtantmedical.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intervention Rates (time frame: 1 month, 3 months, 6 months, 12 months, and 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2024.