Rampart Duo Clinical (RaDical) Post-Market Study

NCT03974711 | Completed DMC

• 1 other identifier: 62-229
• Study Type: observational
• Target: 197
• Locations: 1 country
• Sites: 10

Brief 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.

Conditions

Lumbar Degenerative Disc Disease

Outcome Measures

Primary Outcomes (7)

• 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

• 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

• Short-term objective 2: Hospital economics -- Blood Loss

  Estimated blood loss (EBL) shall be compared to published literature.

  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.

  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.

  Perioperative.

• 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.

• 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 Outcomes (1)

• Additional Outcomes 1 - Radiographic Assessments

  Assessed at 12 months postoperative.

Study Arms (1)

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.

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.

Interventions

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.

All study subjects

Eligibility Criteria

• Age: 21 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Real-world population consistent with cleared labeling for the product.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Spineology, Inc: lead

Study Sites (10)

Bell Neuroscience Institute/Washington Township Medical Foundation

Fremont, California, 94538, United States

Location

Loma Linda University

Loma Linda, California, 92354, United States

Location

Napa Valley Orthopaedic Medical Group

Napa, California, 94558, United States

Location

Georgetown University Hospital

Washington D.C., District of Columbia, 20734, United States

Location

South Florida Spine & Orthopedics

Coconut Creek, Florida, 33073, United States

Location

Orthopaedic Institute of Western Kentucky

Paducah, Kentucky, 42001, United States

Location

Spine Institute of Louisiana

Shreveport, Louisiana, 71101, United States

Location

Orthopedic Institute of Pennsylvania

Camp Hill, Pennsylvania, 17011, United States

Location

Austin Spine Specialists

Austin, Texas, 78705, United States

Location

Spine Works Institute

North Richland Hills, Texas, 76182, United States

Location

MeSH Terms

Conditions

Intervertebral Disc Degeneration

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Study Officials

• Donald Erickson, MD

  Retired

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 29, 2019
• First Posted: June 5, 2019
• Study Start: October 2, 2017
• Primary Completion: April 21, 2022
• Study Completion: October 3, 2022
• Last Updated: December 1, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (10)