Rampart Duo Clinical (RaDical) Post-Market Study

Lumbar Degenerative Disc Disease Clinical Trial

— RaDical  

Official title:

Rampart Duo Clinical (RaDical) Study: An Exempt Minimal Risk Post-Market Evaluation of Clinical Outcomes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03974711
• Other study ID #: 62-229
• Status: Completed
• Start date: October 2, 2017
• Est. completion date: October 3, 2022

Study information

• Verified date: November 2023
• Source: Spineology, Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 197
• Est. completion date: October 3, 2022
• Est. primary completion date: April 21, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 80 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Intervertebral Disc Degeneration
• Lumbar Degenerative Disc Disease

Intervention

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.
There is no intervention performed in this evaluation. Data is being collected in an on-label standard of care lateral lumbar interbody fusion procedure.

Locations

Country	Name	City	State
United States	Austin Spine Specialists	Austin	Texas
United States	Orthopedic Institute of Pennsylvania	Camp Hill	Pennsylvania
United States	South Florida Spine & Orthopedics	Coconut Creek	Florida
United States	Bell Neuroscience Institute/Washington Township Medical Foundation	Fremont	California
United States	Loma Linda University	Loma Linda	California
United States	Napa Valley Orthopaedic Medical Group	Napa	California
United States	Spine Works Institute	North Richland Hills	Texas
United States	Orthopaedic Institute of Western Kentucky	Paducah	Kentucky
United States	Spine Institute of Louisiana	Shreveport	Louisiana
United States	Georgetown University Hospital	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Spineology, Inc

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	3 months
Primary	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).	3 months
Primary	Short-term objective 2: Hospital economics -- Blood Loss	Estimated blood loss (EBL) shall be compared to published literature.	EBL collected at time of surgery.
Primary	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.	DoS collected at time of surgery.
Primary	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.	Perioperative.
Primary	Long-term objective 1: Patient Low back pain change over time	Pain measured on 100 mm VAS and compared to baseline.	Through 12 months postoperative.
Primary	Long-term objective 1: Patient Low back function change over time	Low back function determined on Oswestry Disability Index (ODI) and compared to baseline.	Through 12 months postoperative.
Secondary	Additional Outcomes 1 - Radiographic Assessments	Assess for fusion status	Assessed at 12 months postoperative.