Herniated Lumbar Disk
Conditions
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.
Interventions
DEVICEOxiplex
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.
OTHERSurgery Only
Single level partial discectomy as per standard of care procedures.
Sponsors
FzioMed
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
22 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
1. Be between 22 and 70 years of age; 2. 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; 3. 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); 4. Have at least one of the following: 1. 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. The patient is experiencing intractable pain; or 3. There is substantial progression of loss of neurological function. 5. Have VAS leg pain score in the ipsilateral leg of at least 60mm on a 100mm scale; 6. Have VAS back pain score of at least 50mm on a 100mm scale; 7. Be appropriate for treatment using a posterior surgical approach; 8. Be likely to return for all follow-up visits; and 9. Be willing and able to provide Informed Consent for study participation.
Exclusion criteria
Pre-Operative
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in ipsilateral leg pain | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in back pain | Pre-op; 6 weeks; 3 months; 6 months | 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. |
Countries
United States
Outcome results
None listed