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出境医 / 临床实验 / Rampart Duo Clinical (RaDical) Post-Market Study (RaDical)

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

Study Description
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.
Study Design
Layout table for study information
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 : December 31, 2022
Estimated Study Completion Date : December 31, 2022
Arms and Interventions
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.
Outcome Measures
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


Eligibility Criteria
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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.
Contacts and Locations

Locations
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United States, California
Bell Neuroscience Institute/Washington Township Medical Foundation
Fremont, California, United States, 94538
Loma Linda University
Loma Linda, California, United States, 92354
Napa Valley Orthopaedic Medical Group
Napa, California, United States, 94558
United States, District of Columbia
Georgetown University Hospital
Washington, District of Columbia, United States, 20734
United States, Florida
South Florida Spine & Orthopedics
Coconut Creek, Florida, United States, 33073
United States, Kentucky
Orthopaedic Institute of Western Kentucky
Paducah, Kentucky, United States, 42001
United States, Louisiana
Spine Institute of Louisiana
Shreveport, Louisiana, United States, 71101
United States, Pennsylvania
Orthopedic Institute of Pennsylvania
Camp Hill, Pennsylvania, United States, 17011
United States, Texas
Austin Spine Specialists
Austin, Texas, United States, 78705
Spine Works Institute
North Richland Hills, Texas, United States, 76182
Sponsors and Collaborators
Spineology, Inc
Investigators
Layout table for investigator information
Study Chair: Donald Erickson, M.D. Independent
Tracking Information
First Submitted Date May 29, 2019
First Posted Date June 5, 2019
Last Update Posted Date October 23, 2020
Actual Study Start Date October 2, 2017
Estimated Primary Completion Date December 31, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 31, 2019)
  • 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: 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.
  • 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.
  • 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.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: May 31, 2019) 		Additional Outcomes 1 - Radiographic Assessments [ Time Frame: 24 months ]
Assess for radiographic changes over time
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Rampart Duo Clinical (RaDical) Post-Market Study
Official Title Rampart Duo Clinical (RaDical) Study: An Exempt Minimal Risk Post-Market Evaluation of Clinical Outcomes
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.
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.
Study Type Observational [Patient Registry]
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration 2 Years
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population Real-world population consistent with cleared labeling for the product.
Condition 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.
Study Groups/Cohorts 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.

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.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Active, not recruiting
Estimated Enrollment
 (submitted: May 31, 2019) 		200
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 31, 2022
Estimated Primary Completion Date December 31, 2022   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study: All
Ages 21 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT03974711
Other Study ID Numbers 62-229
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement
Plan to Share IPD: No
Plan Description: IPD will be shared with study researchers for purposes of publication and presentation purposes.
Responsible Party Spineology, Inc
Study Sponsor Spineology, Inc
Collaborators Not Provided
Investigators
Study Chair: Donald Erickson, M.D. Independent
PRS Account Spineology, Inc
Verification Date October 2020

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