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Rampart Duo Clinical (RaDical) Post-Market Study (RaDical)

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ClinicalTrials.gov Identifier: NCT03974711
Recruitment Status : Recruiting
First Posted : June 5, 2019
Last Update Posted : June 5, 2019
Sponsor:
Information provided by (Responsible Party):
Spineology, Inc

Brief Summary:
This exempt, minimal risk, prospective, post-market, registry, multi-center, Institution Review Board (IRB) approved observational clinical evaluation will be conducted at up to a maximum of 20 investigation centers with no more than 200 study subjects being enrolled. Data is being collected for patients undergoing a standard of care, on-label, lateral lumbar interbody fusion. The data collected in this evaluation will be used for publication and presentation.

Condition or disease Intervention/treatment
Lumbar Degenerative Disc Disease 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.

Detailed Description:
The purpose of this study is to collect data that reports on the clinical outcomes of patients treated with the Spineology Rampart DUO device in a standard of care instrumented lateral lumbar interbody fusion procedure at one or two contiguous levels. Data is collected prospectively at specified time points per protocol and includes both objective and subjective measures. Patients will be followed to a maximum of two years.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 2 Years
Official Title: Rampart Duo Clinical (RaDical) Study: An Exempt Minimal Risk Post-Market Evaluation of Clinical Outcomes
Actual Study Start Date : October 2, 2017
Estimated Primary Completion Date : July 31, 2022
Estimated Study Completion Date : July 31, 2022

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. 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.

  2. 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).

  3. 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.

  4. 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.

  5. Short-term objective 2: Hospital economics -- Time-to-Discharge [ Time Frame: 2 week ]
    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.

  6. Long-term objective 1: Patient Low back pain change over time [ Time Frame: Through a maximum of 24 months. ]
    Pain measured on 100 mm VAS and compared to baseline.

  7. Long-term objective 1: Patient Low back function change over time [ Time Frame: Through a maximum of 24 months. ]
    Low back function determined on Oswestry Disability Index (ODI) and compared to baseline.


Secondary Outcome Measures :
  1. Additional Outcomes 1 - Radiographic Assessments [ Time Frame: 24 months ]
    Assess for radiographic changes over time



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Real-world population consistent with cleared labeling for the product.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03974711


Contacts
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Contact: Rose Griffith 6512568503 Rgriffith@spineology.com
Contact: Mike Grillo 651-256-8482 Mgrillo@spineology.com

Locations
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United States, California
Bell Neuroscience Institute/Washington Township Medical Foundation Recruiting
Fremont, California, United States, 94538
Contact: Kristi LaRock, PA    510-818-1160      
Principal Investigator: Sandeep Kunwar, M.D.         
Napa Valley Orthopaedic Medical Group Recruiting
Napa, California, United States, 94558
Contact: Dawn Sousa    707-254-7117      
Principal Investigator: Jason Huffman, M.D.         
United States, Florida
East Coast Orthopaedics Recruiting
Pompano Beach, Florida, United States, 33064
Contact: Jasmine Nieves    954-942-4433      
Principal Investigator: John Malloy IV, D.O.         
United States, Kentucky
Orthopaedic Institute of Western Kentucky Recruiting
Paducah, Kentucky, United States, 42001
Contact: Rebecca Vinson    270-442-9461      
Principal Investigator: Clint Hill, M.D.         
Sub-Investigator: Brandon K Strenge, M.D.         
United States, Louisiana
Spine Institute of Louisiana Recruiting
Shreveport, Louisiana, United States, 71101
Contact: Marcus Stone, Ph.D.    318-629-5555      
Principal Investigator: Pierce Nunley, M.D.         
United States, Texas
Austin Spine Specialists Recruiting
Austin, Texas, United States, 78705
Contact: Krishna Saina    512-544-8070      
Principal Investigator: Craig Kuhns, M.D.         
Sub-Investigator: Richard Wupperman, M.D.         
Spine Works Institute Recruiting
North Richland Hills, Texas, United States, 76182
Contact: Amy Lee    817-616-0700      
Principal Investigator: Jeff Phelps, M.D.         
Sponsors and Collaborators
Spineology, Inc
Investigators
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Study Chair: Donald Erickson, M.D. Independent

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Responsible Party: Spineology, Inc
ClinicalTrials.gov Identifier: NCT03974711     History of Changes
Other Study ID Numbers: 62-229
First Posted: June 5, 2019    Key Record Dates
Last Update Posted: June 5, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: IPD will be shared with study researchers for purposes of publication and presentation purposes.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
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Intervertebral Disc Degeneration
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases