Lumbar Degenerative Disc Disease Clinical Trial
— RaDicalOfficial title:
Rampart Duo Clinical (RaDical) Study: An Exempt Minimal Risk Post-Market Evaluation of Clinical Outcomes
NCT number | NCT03974711 |
Other study ID # | 62-229 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | October 2, 2017 |
Est. completion date | October 3, 2022 |
Verified date | November 2023 |
Source | Spineology, Inc |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational [Patient Registry] |
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.
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. |
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 |
Lead Sponsor | Collaborator |
---|---|
Spineology, Inc |
United States,
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. |
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