Herniated Lumbar DiskNCT03433391
Confirmatory Clinical Study of Oxiplex
A study testing Oxiplex and Surgery Only in people with Herniated Lumbar Disk, run by FzioMed at 17 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 22 to 70 years
- Conditions the study is for
- Herniated Lumbar Disk
- What is being tested?
- Oxiplex and Surgery Only
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 135 participants
- Where
- 17 sitesUnited States
- Study dates
- 23 Apr 2018to 27 Mar 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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;
Show all 50Show fewer
- 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;
- Cauda equina syndrome or neurogenic bowel/bladder dysfunction;
- Any terminal, systemic or autoimmune disease;
- 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;
- Any disease, condition or surgery which might impair healing, such as:
- Diabetes mellitus requiring daily insulin management,
- Active malignancy,
- History of metastatic malignancy;
- Treatment with any epidural steroids within four (4) weeks prior to the surgery;
- Treatment with any oral steroids within ten (10) days prior to the surgery;
- Treatment with aspirin or other non-steroidal anti-inflammatory drugs within seventy-two (72) hours prior to the surgery;
- 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;
- Pregnancy at time of enrollment, or planning to become pregnant, since this would contraindicate surgery2;
- Currently a prisoner;
- Currently involved in litigation which may influence the subject's reporting of symptoms including workers comp;
- Participation in any other investigational drug, biologic or medical device study within the last six months prior to study surgery;
- 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:
- Severe facet disease or facet degeneration at the index lumbar level;
- Dural entry during surgery;
- Discovery of intraspinal tumor during surgery;
- Requires spinal fusion;
- Multilevel herniation or the need to involve more than one level;
- Exploration of contralateral side;
- Epidural fat placement;
- 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
- Surgical determination that a hemostatic agent must remain at the surgery site;
- 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);
- Adverse events or complications assessed during surgery that rule out the use of Oxiplex (e.g., infection, local osteoporosis);
- Application of a sealant or other attempt to repair annular tear;
- 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.);
- The presence of a dural tear and/or opening found during the surgical procedure.
Trial locations and contacts
17 sites in 1 country.
17 sites in 1 country
United States17 sites
Brigham and Women's Hospital
Boston, Massachusetts, 02115
Indiana Spine Group
Carmel, Indiana, 46032
OrthoCarolina Research Insitute
Charlotte, North Carolina, 28207
Rush University Medical Center
Chicago, Illinois, 60612
M3 Emerging Medical Research
Durham, North Carolina, 27704
NorthShore University Health System
Evanston, Illinois, 60201
Northwell Health Physician Partners
Great Neck, New York, 11021
St. Luke's Hospital
Kansas City, Missouri, 64111
Orthopaedic Institute of Western Kentucky
Paducah, Kentucky, 42003
Desert Institute for Spine Care
Phoenix, Arizona, 85020
Texas Back Institute
Plano, Texas, 75093
William Beaumont Hospital
Royal Oak, Michigan, 48073
UC Davis Spine Center
Sacramento, California, 95816
Kennedy-White Orthopaedic Center
Sarasota, Florida, 34232
Center for Neurosciences
Tucson, Arizona, 85718
Carle Foundation Hospital
Urbana, Illinois, 61801
Orlando Neurosurgery
Winter Park, Florida, 32789
About this study
Official title: Confirmatory Clinical Study to Support the Effectiveness and Safety of Oxiplex for the Reduction of Pain and Symptoms Following Lumbar Surgery
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.
- Conditions
- Herniated Lumbar Disk
- Being tested
- Oxiplex, Surgery Only
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OxiplexDevice
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.
Surgery OnlyOther
Single level partial discectomy as per standard of care procedures.
| Study group | Role | What they receive |
|---|---|---|
| Surgery Plus Oxiplex | Other | Oxiplex will be applied after hemostasis is achieved and prior to closure, in adult patients undergoing single level partial discectomy. Receives: Device: Oxiplex |
| Surgery Only | Other | Standard of care procedures for adult patients undergoing single level partial discectomy will be followed. Receives: Other: Surgery Only |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in ipsilateral leg pain
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".
Measured: Pre-op; 6 weeks; 3 months; 6 months
Secondary outcomes (1)
Change in back pain
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".
Measured: Pre-op; 6 weeks; 3 months; 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2018
- Study start23 Apr 2018
- Primary completion23 Jun 2020
- Study completion27 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Herniated Lumbar DiskStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 135 participants (actual)
Sponsor and investigators
- Lead sponsor
- FzioMed
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jeffrey Fischgrund, MD, Principal investigator, Beaumont Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03433391
- Sponsor's protocol ID
- FZ-SP007
- Status last verified
- Jun 2024
- First submitted
- 8 Feb 2018
- Last updated
- 27 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 21897344Kim 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.
PubMed 12768153
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Confirmatory Clinical Study to Support the Effectiveness and Safety of Oxiplex for the Reduction of Pain and Symptoms Following Lumbar Surgery
- ClinicalTrials.gov ID
- NCT03433391
- Acronym / sponsor ID
- FZ-SP007
- Conditions
- Herniated Lumbar Disk
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 135 participants (actual)
- Lead sponsor
- FzioMedIndustry (pharma, biotech, devices)
- Study start
- 23 Apr 2018 (actual)
- Primary completion
- 23 Jun 2020 (actual)
- Study completion
- 27 Mar 2024 (actual)
- First posted
- 14 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Surgery Plus Oxiplex | Other | Device: OxiplexOxiplex will be applied after hemostasis is achieved and prior to closure, in adult patients undergoing single level partial discectomy. |
| Surgery Only | Other | Other: Surgery OnlyStandard of care procedures for adult patients undergoing single level partial discectomy will be followed. |
Who may qualify
- Ages
- 22 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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:
- Have VAS leg pain score in the ipsilateral leg of at least 60mm on a 100mm scale;
Key exclusion criteria (50 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OxiplexOxiplex 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. | Device | Surgery Plus Oxiplex |
| Surgery OnlySingle level partial discectomy as per standard of care procedures. | Other | Surgery Only |
Primary outcome
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".
1 secondary outcome
Change in back pain
Time frame: Pre-op; 6 weeks; 3 months; 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2024.
- Background: PubMed 21897344Rhyne 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.
- Background: PubMed 12768153Kim 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.
- Sponsor WebsiteLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jeffrey Fischgrund, MD principal investigator
Beaumont Health
17 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oxiplex and Surgery Only in people with Herniated Lumbar Disk, run by FzioMed at 17 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 50 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in ipsilateral leg pain (time frame: Pre-op; 6 weeks; 3 months; 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03433391, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jun 2024; AzTrials last refreshed its copy on 1 Nov 2026.