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

FzioMed17 sites in 1 country135 target enrollmentApril 23, 2018

ConditionsHerniated Lumbar Disk

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Herniated Lumbar Disk
Sponsor: FzioMed
Enrollment: 135
Locations: 17
Primary Endpoint: Change in ipsilateral leg pain
Status: Completed
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

April 23, 2018

End Date

March 27, 2024

Last Updated

last year

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

FzioMed

Responsible Party

Sponsor

Eligibility Criteria

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;

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;

Outcomes

Primary Outcomes

Change in ipsilateral leg pain

Time Frame: Pre-op; 6 weeks; 3 months; 6 months

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".