Rampart Duo Clinical (RaDical) Post-Market Study (RaDical)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03974711|
Recruitment Status : Recruiting
First Posted : June 5, 2019
Last Update Posted : June 5, 2019
|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.|
|Study Type :||Observational [Patient Registry]|
|Estimated Enrollment :||200 participants|
|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|
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.
- 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.
- Additional Outcomes 1 - Radiographic Assessments [ Time Frame: 24 months ]Assess for radiographic changes over time
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03974711
|Contact: Rose Griffith||6512568503||Rgriffith@spineology.com|
|Contact: Mike Grillo||651-256-8482||Mgrillo@spineology.com|
|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.|
|Study Chair:||Donald Erickson, M.D.||Independent|