Confirmatory Clinical Study of Oxiplex

Completed · Not applicable

Conditions studied: Herniated Lumbar Disk

In brief

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.

Key facts

Study ID

NCT03433391

Run by

FzioMed

People needed

135

Starts

2018-04-23

Expected to finish

2024-03-27

Last updated by the study team

2024-06-27

Who can join

Age: 22 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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;

Where it is running

• Desert Institute for Spine Care — Phoenix, Arizona, United States
• Center for Neurosciences — Tucson, Arizona, United States
• UC Davis Spine Center — Sacramento, California, United States
• Kennedy-White Orthopaedic Center — Sarasota, Florida, United States
• Orlando Neurosurgery — Winter Park, Florida, United States
• Rush University Medical Center — Chicago, Illinois, United States
• NorthShore University Health System — Evanston, Illinois, United States
• Carle Foundation Hospital — Urbana, Illinois, United States
• Indiana Spine Group — Carmel, Indiana, United States
• Orthopaedic Institute of Western Kentucky — Paducah, Kentucky, United States
• Brigham and Women's Hospital — Boston, Massachusetts, United States
• William Beaumont Hospital — Royal Oak, Michigan, United States
• St. Luke's Hospital — Kansas City, Missouri, United States
• Northwell Health Physician Partners — Great Neck, New York, United States
• OrthoCarolina Research Insitute — Charlotte, North Carolina, United States
• M3 Emerging Medical Research — Durham, North Carolina, United States
• Texas Back Institute — Plano, Texas, United States

Full record on ClinicalTrials.gov

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