Lumbar Degenerative Disc DiseaseRaDicalNCT03974711
Rampart Duo Clinical (RaDical) Post-Market Study
An observational study of Lumbar Degenerative Disc Disease, run by Spineology, Inc at 10 sites in United States.
Trial summary
This exempt, minimal risk, prospective, post-market, registry, multi-center, Institution Review Board (IRB) approved observational clinical evaluation was conducted at 10 centers. A total of 197 patients were enrolled. Read more about this study
- Who is it for?
- Ages 21 to 80 years
- Conditions the study is for
- Lumbar Degenerative Disc Disease
- How many people
- 197 participants
- Where
- 10 sitesUnited States
- Study dates
- 2 Oct 2017to 3 Oct 2022
- How long will I take part?
- 1 Year
- 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 21 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Real-world population consistent with cleared labeling for the product.
Who may be able to join
- A clinical decision has been made to treat the patient with the Rampart Duo Interbody Spacer prior to enrollment into this research evaluation. This decision is independent (made outside) of the decision to take part in the research.
Who cannot join
- Previous interbody fusion or total disc replacement at the index level(s).
- Enrolled in a concurrent clinical investigation that may confound the findings of the present investigation.
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United States10 sites
Austin Spine Specialists
Austin, Texas, 78705
Orthopedic Institute of Pennsylvania
Camp Hill, Pennsylvania, 17011
South Florida Spine & Orthopedics
Coconut Creek, Florida, 33073
Bell Neuroscience Institute/Washington Township Medical Foundation
Fremont, California, 94538
Loma Linda University
Loma Linda, California, 92354
Napa Valley Orthopaedic Medical Group
Napa, California, 94558
Spine Works Institute
North Richland Hills, Texas, 76182
Orthopaedic Institute of Western Kentucky
Paducah, Kentucky, 42001
Spine Institute of Louisiana
Shreveport, Louisiana, 71101
Georgetown University Hospital
Washington D.C., District of Columbia, 20734
About this study
Official title: Rampart Duo Clinical (RaDical) Study: An Exempt Minimal Risk Post-Market Evaluation of Clinical Outcomes
This exempt, minimal risk, prospective, post-market, registry, multi-center, Institution Review Board (IRB) approved observational clinical evaluation was conducted at 10 centers. A total of 197 patients were enrolled. The evaluation collected data in a real-world patient population and was a data collection initiative only. No patient treatments or care were performed as a component of the protocol. All patient care received was on-label and standard of care for lateral lumbar interbody fusions. The data collected in this evaluation is intended to contribute to the body of literature for lateral lumbar interbody fusions.
Read the detailed description
The purpose of this study was to collect data that reports on the clinical outcomes of patients that were treated with the Spineology Rampart DUO device in a standard of care instrumented lateral lumbar interbody fusion procedure at one or two contiguous levels from L2-L5. Data was collected prospectively at specified time points per protocol and included both objective and subjective measures. The study concluded when the final patient achieved their 12-month evaluation.
- Conditions
- Lumbar Degenerative Disc Disease
- Being tested
- In this evaluation, no interventions are performed. It is a data collection effort only. The "procedure" for this study is the data collection effort.
- Medical subject headings
- Intervertebral Disc Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
In this evaluation, no interventions are performed. It is a data collection effort only. The "procedure" for this study is the data collection effort.Other
There is no intervention performed in this evaluation. Data is being collected in an on-label standard of care lateral lumbar interbody fusion procedure.
| Study group | Role | What they receive |
|---|---|---|
| All study subjects | Note: No interventions are administered under this evaluation.
This is a real-world population. The determination to undergo a lateral lumbar interbody fusion procedure is made outside of this evaluation and is a standard of care, on-label procedure. Receives: Other: In this evaluation, no interventions are performed. It is a data collection effort only. The "procedure" for this study is the data collection effort. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Short-term objective 1: New onset of thigh symptoms -- Anterior Thigh Pain Change from Baseline
Change from Baseline anterior thigh pain score through 3-months. Pain assessment captured on 100 mm VAS. A higher VAS score represents a worsening of pain.
Measured: 3 months
Short-term objective 1: New onset of thigh symptoms -- Thigh Neurological Change from Baseline
Change from baseline in anterior thigh neurological assessment through 3 months. Anterior Thigh Neurological deficit defined as a negative change in strength (hip/flexor weakness) or sensation (anterior thigh).
Measured: 3 months
Short-term objective 2: Hospital economics -- Blood Loss
Estimated blood loss (EBL) shall be compared to published literature.
Measured: EBL collected at time of surgery.
Short-term objective 2: Hospital economics -- Duration of Surgery
Duration of surgery (DoS) defined as time from incision to closure shall be compared to published literature.
Measured: DoS collected at time of surgery.
Short-term objective 2: Hospital economics -- Time-to-Discharge
Time-to-discharge (TTD) defined as time from hospital admission to the time the subject is discharged from the hospital and it shall be compared to published literature.
Measured: Perioperative.
Long-term objective 1: Patient Low back pain change over time
Pain measured on 100 mm VAS and compared to baseline.
Measured: Through 12 months postoperative.
Long-term objective 1: Patient Low back function change over time
Low back function determined on Oswestry Disability Index (ODI) and compared to baseline.
Measured: Through 12 months postoperative.
Secondary outcomes (1)
Additional Outcomes 1 - Radiographic Assessments
Assess for fusion status
Measured: Assessed at 12 months postoperative.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2019
- Study start2 Oct 2017
- Primary completion21 Apr 2022
- Study completion3 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lumbar Degenerative Disc DiseaseStudies 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
- 197 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Spineology, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Donald Erickson, MD, Study chair, Retired
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03974711
- Sponsor's protocol ID
- 62-229
- Acronym
- RaDical
- Status last verified
- Nov 2023
- First submitted
- 29 May 2019
- Last updated
- 1 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will be shared with study researchers for purposes of publication and presentation purposes.
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rampart Duo Clinical (RaDical) Study: An Exempt Minimal Risk Post-Market Evaluation of Clinical Outcomes
- ClinicalTrials.gov ID
- NCT03974711
- Acronym / sponsor ID
- RaDical / 62-229
- Conditions
- Lumbar Degenerative Disc Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 197 participants (actual)
- Lead sponsor
- Spineology, IncIndustry (pharma, biotech, devices)
- Study start
- 2 Oct 2017 (actual)
- Primary completion
- 21 Apr 2022 (actual)
- Study completion
- 3 Oct 2022 (actual)
- First posted
- 5 Jun 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 exempt, minimal risk, prospective, post-market, registry, multi-center, Institution Review Board (IRB) approved observational clinical evaluation was conducted at 10 centers. A total of 197 patients were enrolled. The evaluation collected data in a real-world patient population and was a data collection initiative only. No patient treatments or care were performed as a component of the protocol. All patient care received was on-label and standard of care for lateral lumbar interbody fusions. The data collected in this evaluation is intended to contribute to the body of literature for lateral lumbar interbody fusions.
Detailed description
The purpose of this study was to collect data that reports on the clinical outcomes of patients that were treated with the Spineology Rampart DUO device in a standard of care instrumented lateral lumbar interbody fusion procedure at one or two contiguous levels from L2-L5. Data was collected prospectively at specified time points per protocol and included both objective and subjective measures. The study concluded when the final patient achieved their 12-month evaluation.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All study subjects | – | Other: In this evaluation, no interventions are performed. It is a data collection effort only. The "procedure" for this study is the data collection effort.Note: No interventions are administered under this evaluation. This is a real-world population. The determination to undergo a lateral lumbar interbody fusion procedure is made outside of this evaluation and is a standard of care, on-label procedure. |
Who may qualify
- Ages
- 21 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Real-world population consistent with cleared labeling for the product.
Key inclusion criteria (1 listed)
- A clinical decision has been made to treat the patient with the Rampart Duo Interbody Spacer prior to enrollment into this research evaluation. This decision is independent (made outside) of the decision to take part in the research.
Key exclusion criteria (2 listed)
- Previous interbody fusion or total disc replacement at the index level(s).
- Enrolled in a concurrent clinical investigation that may confound the findings of the present investigation.
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 |
|---|---|---|
| In this evaluation, no interventions are performed. It is a data collection effort only. The "procedure" for this study is the data collection effort.There is no intervention performed in this evaluation. Data is being collected in an on-label standard of care lateral lumbar interbody fusion procedure. | Other | All study subjects |
Primary outcome
Short-term objective 1: New onset of thigh symptoms -- Anterior Thigh Pain Change from Baseline
Time frame: 3 months
Change from Baseline anterior thigh pain score through 3-months. Pain assessment captured on 100 mm VAS. A higher VAS score represents a worsening of pain.
Short-term objective 1: New onset of thigh symptoms -- Thigh Neurological Change from Baseline
Time frame: 3 months
Change from baseline in anterior thigh neurological assessment through 3 months. Anterior Thigh Neurological deficit defined as a negative change in strength (hip/flexor weakness) or sensation (anterior thigh).
Short-term objective 2: Hospital economics -- Blood Loss
Time frame: EBL collected at time of surgery.
Estimated blood loss (EBL) shall be compared to published literature.
Short-term objective 2: Hospital economics -- Duration of Surgery
Time frame: DoS collected at time of surgery.
Duration of surgery (DoS) defined as time from incision to closure shall be compared to published literature.
Short-term objective 2: Hospital economics -- Time-to-Discharge
Time frame: Perioperative.
Time-to-discharge (TTD) defined as time from hospital admission to the time the subject is discharged from the hospital and it shall be compared to published literature.
Long-term objective 1: Patient Low back pain change over time
Time frame: Through 12 months postoperative.
Pain measured on 100 mm VAS and compared to baseline.
Long-term objective 1: Patient Low back function change over time
Time frame: Through 12 months postoperative.
Low back function determined on Oswestry Disability Index (ODI) and compared to baseline.
1 secondary outcome
Additional Outcomes 1 - Radiographic Assessments
Time frame: Assessed at 12 months postoperative.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2023.
- Individual participant dataSharing planned: No. IPD will be shared with study researchers for purposes of publication and presentation purposes.
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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.
Donald Erickson, MD study chair
Retired
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lumbar Degenerative Disc Disease, run by Spineology, Inc at 10 sites in United States.
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 1 inclusion and 2 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: finished, as of the sponsor's last update on 1 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Short-term objective 1: New onset of thigh symptoms -- Anterior Thigh Pain Change from Baseline (time frame: 3 months). The study lists 7 primary outcomes in all. 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 1 Dec 2023.