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Clinical Trial Details — Status: Completed

Administrative data

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

Study information

Verified date November 2023
Source Spineology, Inc
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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.


Description:

The purpose of this study was to collect data that reports on the clinical outcomes of patients that were treated with the Spineology Rampart DUO device in a standard of care instrumented lateral lumbar interbody fusion procedure at one or two contiguous levels from L2-L5. Data was collected prospectively at specified time points per protocol and included both objective and subjective measures. The study concluded when the final patient achieved their 12-month evaluation.


Recruitment information / eligibility

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.

Study Design


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.

Locations

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

Sponsors (1)

Lead Sponsor Collaborator
Spineology, Inc

Country where clinical trial is conducted

United States, 

Outcome

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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