Status:
WITHDRAWN
Clinical Evaluation of the ReLeaf Analgesic Infusion Catheter & Wound Drain
Lead Sponsor:
Vital 5, LLC
Conditions:
Low Back Pain
Eligibility:
All Genders
18-85 years
Phase:
NA
Brief Summary
The purpose of this study is to evaluate the clinical performance of the ReLeaf infusion catheter \& wound drain in patients following lumbar spinal fusion surgery. One half of the patients will recei...
Detailed Description
Posterior lumbar spinal fusion is commonly used in the management of a wide array of spinal disorders ranging from instability to degenerative disc disease. However, severe postoperative pain is a sig...
Eligibility Criteria
Inclusion
- Skeletally mature
- Diagnosis of lumbar spine disease requiring an open, midline, instrumented posterolateral fusion with or without interbody support at one or two vertebral levels and laminectomy or laminotomy
- Physically and mentally willing to comply with the study requirements
- Signed the study informed consent
Exclusion
- Lumbar spine disease requiring more than two levels of instrumentation
- Any previous operative lumbar procedure, except discectomy or hemi-laminotomy performed a minimum of 2 years prior to current study surgery
- Patients requiring iliac crest bone graft for the procedure
- Intra-operative durotomy
- Any duration of pre-operative morphine or morphine equivalent use exceeding 30 mg of morphine equivalents per day for longer than 3 months
- Physically or mentally compromised (i.e., being currently treated for a psychiatric disorder, senile dementia, Alzheimer's disease, presence of alcohol or substance abuse)
- Diagnosed with Severe Depression and on treatment
- Active infection at the operative level or a symptomatic infection
- Diagnosed systemic disease that would affect the subject's welfare or overall outcome of the research study (i.e. Paget's disease, renal osteodystrophy, Lupus etc)
- Is pregnant or breast feeding
- Has any active malignancy or spinal arthrodesis being performed for a tumor decompression
- Has a known allergy to local analgesics
- Pending litigation related to back pain or injury or Worker's Compensation
Key Trial Info
Start Date :
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2016
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT02293525
End Date
January 1 2016
Last Update
January 22 2016
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