Clinical Evaluation of the ReLeaf Analgesic Infusion Catheter & Wound Drain

• Status: Withdrawn
• Trial end date: 2016-01-01
• Target enrollment: 0
• Participant gender: All

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 receive continuous local analgesic fusion during the post-operative period while the other half will received continuous local saline.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Vital 5, LLC
• Treatments: Analgesics; Morphine; Oxycodone; Ropivacaine

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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