NCT03433391

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
135

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

17 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 8, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 14, 2018

Completed
2 months until next milestone

Study Start

First participant enrolled

April 23, 2018

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 23, 2020

Completed
3.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 27, 2024

Completed
Last Updated

June 27, 2024

Status Verified

June 1, 2024

Enrollment Period

2.2 years

First QC Date

February 8, 2018

Last Update Submit

June 25, 2024

Conditions

Herniated Lumbar Disk

Outcome Measures

Primary Outcomes (1)

  • 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".

    Pre-op; 6 weeks; 3 months; 6 months

Secondary Outcomes (1)

  • Change in back pain

    Pre-op; 6 weeks; 3 months; 6 months

Study Arms (2)

Surgery Plus Oxiplex

OTHER

Oxiplex will be applied after hemostasis is achieved and prior to closure, in adult patients undergoing single level partial discectomy.

Device: Oxiplex

Surgery Only

OTHER

Standard of care procedures for adult patients undergoing single level partial discectomy will be followed.

Other: Surgery Only

Interventions

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 Plus Oxiplex
Surgery OnlyOTHER

Single level partial discectomy as per standard of care procedures.

Surgery Only

Eligibility Criteria

Age22 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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;
  • 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,
  • +32 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (17)

Desert Institute for Spine Care

Phoenix, Arizona, 85020, United States

Location

Center for Neurosciences

Tucson, Arizona, 85718, United States

Location

UC Davis Spine Center

Sacramento, California, 95816, United States

Location

Kennedy-White Orthopaedic Center

Sarasota, Florida, 34232, United States

Location

Orlando Neurosurgery

Winter Park, Florida, 32789, United States

Location

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

NorthShore University Health System

Evanston, Illinois, 60201, United States

Location

Carle Foundation Hospital

Urbana, Illinois, 61801, United States

Location

Indiana Spine Group

Carmel, Indiana, 46032, United States

Location

Orthopaedic Institute of Western Kentucky

Paducah, Kentucky, 42003, United States

Location

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

William Beaumont Hospital

Royal Oak, Michigan, 48073, United States

Location

St. Luke's Hospital

Kansas City, Missouri, 64111, United States

Location

Northwell Health Physician Partners

Great Neck, New York, 11021, United States

Location

OrthoCarolina Research Insitute

Charlotte, North Carolina, 28207, United States

Location

M3 Emerging Medical Research

Durham, North Carolina, 27704, United States

Location

Texas Back Institute

Plano, Texas, 75093, United States

Location

Related Publications (2)

  • 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.

    PMID: 21897344BACKGROUND

  • 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.

    PMID: 12768153BACKGROUND

Related Links

Study Officials

  • Jeffrey Fischgrund, MD

    Beaumont Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 8, 2018

First Posted

February 14, 2018

Study Start

April 23, 2018

Primary Completion

June 23, 2020

Study Completion

March 27, 2024

Last Updated

June 27, 2024

Record last verified: 2024-06

Data Sharing

IPD Sharing
Will not share

Locations

US(17)