Status:
COMPLETED
Confirmatory Clinical Study of Oxiplex
Lead Sponsor:
FzioMed
Conditions:
Herniated Lumbar Disk
Eligibility:
All Genders
22-70 years
Phase:
NA
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...
Eligibility Criteria
Inclusion
- 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
- Pre-Operative
Key Trial Info
Start Date :
April 23 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 27 2024
Estimated Enrollment :
135 Patients enrolled
Trial Details
Trial ID
NCT03433391
Start Date
April 23 2018
End Date
March 27 2024
Last Update
June 27 2024
Active Locations (17)
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1
Desert Institute for Spine Care
Phoenix, Arizona, United States, 85020
2
Center for Neurosciences
Tucson, Arizona, United States, 85718
3
UC Davis Spine Center
Sacramento, California, United States, 95816
4
Kennedy-White Orthopaedic Center
Sarasota, Florida, United States, 34232