Confirmatory Clinical Study of Oxiplex

Study Overview
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Brief Summary
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This is a prospective, multi-center, randomized, controlled, patient and evaluator-blinded clinical study to assess the safety and effectiveness for the reduction of pain and symptoms following lumbar surgery.

Official Title
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Confirmatory Clinical Study to Support the Effectiveness and Safety of Oxiplex for the Reduction of Pain and Symptoms Following Lumbar Surgery

Conditions
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Herniated Lumbar Disk

Intervention / Treatment
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* Device: Oxiplex
* Other: Surgery Only


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Be between 22 and 70 years of age; Have symptomatic posterior or posterolateral disc herniation at L4-L5 or L5-S1 with radiographic confirmation of nerve compression using MRI that requires partial surgical discectomy with or without laminotomy; Have radiculopathy (e.g., decreased motor strength, sensory deficits, decreased reflexes) from specific nerve root distribution from L4 to S1 with positive straight leg raise (0-60 degrees); Have at least one of the following: At least six weeks of prior conservative treatment (e.g., physical therapy and/or use of anti-inflammatory medications, narcotics, and muscle relaxants at the manufacturer's recommended therapeutic dose); The patient is experiencing intractable pain; or There is substantial progression of loss of neurological function. Have VAS leg pain score in the ipsilateral leg of at least 60mm on a 100mm scale; Have VAS back pain score of at least 50mm on a 100mm scale; Be appropriate for treatment using a posterior surgical approach; Be likely to return for all follow-up visits; and Be willing and able to provide Informed Consent for study participation. Exclusion Criteria: Pre-Operative Exclusion Criteria: Radiographic confirmation (via MRI) of severe facet disease or facet degeneration at the index lumbar level; Prior spine surgery at any lumbar level; Subject requires spinal surgery other than a partial discectomy (with or without laminotomy) to treat leg/back pain (osteophyte removal is allowed); Previous trauma to the lumbar spine resulting in fracture or documented ligament injury; Documented presence of a free nuclear fragment at lumbar levels other than the study level; Axial back pain only (no radicular symptoms); Recent history (within previous six months) of chemical or alcohol dependence; Active systemic infection; Infection at the site of surgery; Cauda equina syndrome or neurogenic bowel/bladder dysfunction; Any terminal, systemic or autoimmune disease; Metabolic bone disease (e.g., osteoporosis/osteopenia, gout, osteomalacia, Paget's disease); as defined by use of anti-resorptive medications or a history of fragility fracture; Any disease, condition or surgery which might impair healing, such as: Diabetes mellitus requiring daily insulin management, Active malignancy, History of metastatic malignancy; Treatment with any epidural steroids within four (4) weeks prior to the surgery; Treatment with any oral steroids within ten (10) days prior to the surgery; Treatment with aspirin or other non-steroidal anti-inflammatory drugs within seventy-two (72) hours prior to the surgery; Currently experiencing an episode of major mental illness (psychosis, major affective disorder, or schizophrenia), or manifesting physical symptoms without a diagnosable medical condition to account for the symptoms, which may indicate symptoms of psychological rather than physical origin; Pregnancy at time of enrollment, or planning to become pregnant, since this would contraindicate surgery2; Currently a prisoner; Currently involved in litigation which may influence the subject's reporting of symptoms including workers comp; Participation in any other investigational drug, biologic or medical device study within the last six months prior to study surgery; Requires removal of far lateral disc herniations at L4/5 or L5/S1. Intra-operative Exclusion Criteria: In case the surgeon identifies during surgery any circumstance that contradicts to the patient's participation in the trial, the surgeon should exclude the patient from trial participation. Exclusion reasons are: Severe facet disease or facet degeneration at the index lumbar level; Dural entry during surgery; Discovery of intraspinal tumor during surgery; Requires spinal fusion; Multilevel herniation or the need to involve more than one level; Exploration of contralateral side; Epidural fat placement; Application of products to the exposed neural element, including: Amniotic tissue or fluids Adhesives Steroids Platelet rich plasma Gelfoam Allograft tissue Fibrin glue Dural patches Surgical determination that a hemostatic agent must remain at the surgery site; Surgical determination of the need for any other device (that would interfere with interpretation of the study results) to remain at the surgery site (e.g., surgical drains); Adverse events or complications assessed during surgery that rule out the use of Oxiplex (e.g., infection, local osteoporosis); Application of a sealant or other attempt to repair annular tear; Implantation of antibiotic powder into the surgical wound. (Antibiotic irrigation may be used in the treatment group prior to Oxiplex application and the control group following surgery. No irrigation is allowed after Oxiplex application.); The presence of a dural tear and/or opening found during the surgical procedure.

Ages Eligible for Study
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Minimum Age: 22 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Surgery Plus Oxiplex<br>Oxiplex will be applied after hemostasis is achieved and prior to closure, in adult patients undergoing single level partial discectomy. | Device: Oxiplex<br>* Oxiplex is a clear, viscoelastic gel that is applied to operative site during lumbar spine surgery in order to coat the nerve root with a protective barrier.<br>|
| Other: Surgery Only<br>Standard of care procedures for adult patients undergoing single level partial discectomy will be followed. | Other: Surgery Only<br>* Single level partial discectomy as per standard of care procedures.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in ipsilateral leg pain | Subjects will complete a Visual Analogue Scale (VAS) for their ipsilateral leg pain at each visit. The VAS is a continuous and linear, scale ranging from No Pain to Worst Possible Pain. | Pre-op; 6 weeks; 3 months; 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in back pain | Subjects will complete a Visual Analogue Scale (VAS) for their back pain at each visit.The VAS is a continuous and linear, scale ranging from No Pain to Worst Possible Pain. | Pre-op; 6 weeks; 3 months; 6 months |