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Reduction of Pain and Symptoms Following Lumbar Surgery Study

Clinical Trial Title: 
Confirmatory clinical study to support the effectiveness and safety of oxiplex for the reduction of pain and symptoms following lumbar surgery.
Clinical Trial Protocol ID: 
17120401
Clinical Trial Investigator Name: 
Harel Deutsch, MD
Clinical Trial Protocol Description: 

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.

Clinical Trial Eligibility Criteria: 

In order to participate you must meet the following criteria:

  • Are 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:
  1. Have had 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).
  2. Are experiencing intractable pain.
  3. Have substantial progression of loss of neurological function.

You will be excluded from the study if any of the following criteria apply to you:

  • Have radiographic confirmation (via MRI) of severe facet disease or facet degeneration at the index lumbar level.
  • Have had prior spine surgery at any lumbar level.
  • Require spinal surgery other than a partial discectomy (with or without laminotomy) to treat leg/back pain (osteophyte removal is allowed).
  • Have had previous trauma to the lumbar spine resulting in fracture or documented ligament injury.

This is a partial list of inclusion and exclusion criteria.

Clinical Trial Area: 
Pain Management
Spine and Back Disorders
Contact Phone: 
(312) 942-8681
Contact Name: 
Chris Keegan