Clinical trial NCT03433391: Confirmatory Clinical Study of Oxiplex
Official title: Confirmatory Clinical Study to Support the Effectiveness and Safety of Oxiplex for the Reduction of Pain and Symptoms Following Lumbar Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Herniated Lumbar Disk
Lead sponsor: FzioMed
Sponsor class: INDUSTRY
First posted: 2018-02-14
Enrollment: 135
Sex: ALL
Minimum age (years): 22
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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 Exclusion Criteria:

1. Radiographic confirmation (via MRI) of severe facet disease or facet degeneration at the index lumbar level;
2. Prior spine surgery at any lumbar level;
3. Subject requires spinal surgery other than a partial discectomy (with or without laminotomy) to treat leg/back pain (osteophyte removal is allowed);
4. Previous trauma to the lumbar spine resulting in fracture or documented ligament injury;
5. Documented presence of a free nuclear fragment at lumbar levels other than the study level;
6. Axial back pain only (no radicular symptoms);
7. Recent history (within previous six months) of chemical or alcohol dependence;
8. Active systemic infection;
9. Infection at the site of surgery;
10. Cauda equina syndrome or neurogenic bowel/bladder dysfunction;
11. Any terminal, systemic or autoimmune disease;
12. 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;
13. Any disease, condition or surgery which might impair healing, such as:

    * Diabetes mellitus requiring daily insulin management,
    * Active malignancy,
    * History of metastatic malignancy;
14. Treatment with any epidural steroids within four (4) weeks prior to the surgery;
15. Treatment with any oral steroids within ten (10) days prior to the surgery;
16. Treatment with aspirin or other non-steroidal anti-inflammatory drugs within seventy-two (72) hours prior to the surgery;
17. 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;
18. Pregnancy at time of enrollment, or planning to become pregnant, since this would contraindicate surgery2;
19. Currently a prisoner;
20. Currently involved in litigation which may influence the subject's reporting of symptoms including workers comp;
21. Participation in any other investigational drug, biologic or medical device study within the last six months prior to study surgery;
22. Requires removal of far lateral disc herniations at L4/5 or L5/S1.

Intra-operative Exclusion Criteria:

In case the surgeon identifies during surgery any circumstance that contradicts to the patient's participation in the trial, the surgeon should exclude the patient from trial participation. Exclusion reasons are:

1. Severe facet disease or facet degeneration at the index lumbar level;
2. Dural entry during surgery;
3. Discovery of intraspinal tumor during surgery;
4. Requires spinal fusion;
5. Multilevel herniation or the need to involve more than one level;
6. Exploration of contralateral side;
7. Epidural fat placement;
8. Application of products to the exposed neural element, including:

   * Amniotic tissue or fluids
   * Adhesives
   * Steroids
   * Platelet rich plasma
   * Gelfoam
   * Allograft tissue
   * Fibrin glue
   * Dural patches
9. Surgical determination that a hemostatic agent must remain at the surgery site;
10. Surgical determination of the need for any other device (that would interfere with interpretation of the study results) to remain at the surgery site (e.g., surgical drains);
11. Adverse events or complications assessed during surgery that rule out the use of Oxiplex (e.g., infection, local osteoporosis);
12. Application of a sealant or other attempt to repair annular tear;
13. Implantation of antibiotic powder into the surgical wound. (Antibiotic irrigation may be used in the treatment group prior to Oxiplex application and the control group following surgery. No irrigation is allowed after Oxiplex application.);
14. The presence of a dural tear and/or opening found during the surgical procedure.

Primary outcomes:
measure: Change in ipsilateral leg pain
timeFrame: Pre-op; 6 weeks; 3 months; 6 months
Secondary outcomes:
measure: Change in back pain
timeFrame: Pre-op; 6 weeks; 3 months; 6 months
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Desert Institute for Spine Care
state: Arizona
city: Tucson
country: United States
facility: Center for Neurosciences
state: Arizona
city: Sacramento
country: United States
facility: UC Davis Spine Center
state: California
city: Sarasota
country: United States
facility: Kennedy-White Orthopaedic Center
state: Florida
city: Winter Park
country: United States
facility: Orlando Neurosurgery
state: Florida
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
city: Evanston
country: United States
facility: NorthShore University Health System
state: Illinois
city: Urbana
country: United States
facility: Carle Foundation Hospital
state: Illinois
city: Carmel
country: United States
facility: Indiana Spine Group
state: Indiana
city: Paducah
country: United States
facility: Orthopaedic Institute of Western Kentucky
state: Kentucky
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
city: Royal Oak
country: United States
facility: William Beaumont Hospital
state: Michigan
city: Kansas City
country: United States
facility: St. Luke's Hospital
state: Missouri
city: Great Neck
country: United States
facility: Northwell Health Physician Partners
state: New York
city: Charlotte
country: United States
facility: OrthoCarolina Research Insitute
state: North Carolina
city: Durham
country: United States
facility: M3 Emerging Medical Research
state: North Carolina
city: Plano
country: United States
facility: Texas Back Institute
state: Texas
Study officials:
affiliation: Beaumont Health
name: Jeffrey Fischgrund, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Rhyne AL, Blumenthal SL, Frank EH, Hsu KY, Kim KD, Youssef JA, Wang JC, Arnold P, BenDebba M, Block KM, Juarez TG, Chiacchierini RP, Ehmsen RJ, Krelle JS, diZerega GS; Oxiplex Clinical Study Group. Oxiplex reduces leg pain, back pain, and associated symptoms after lumbar discectomy. Spine (Phila Pa 1976). 2012 Apr 15;37(8):631-41. doi: 10.1097/BRS.0b013e3182309af7.
citation: Kim KD, Wang JC, Robertson DP, Brodke DS, Olson EM, Duberg AC, BenDebba M, Block KM, diZerega GS. Reduction of radiculopathy and pain with Oxiplex/SP gel after laminectomy, laminotomy, and discectomy: a pilot clinical study. Spine (Phila Pa 1976). 2003 May 15;28(10):1080-7; discussion 1087-8. doi: 10.1097/01.BRS.0000062354.26905.B8.